<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03282682</url>
  </required_header>
  <id_info>
    <org_study_id>FSPORT-CU-ADAM</org_study_id>
    <nct_id>NCT03282682</nct_id>
  </id_info>
  <brief_title>Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male</brief_title>
  <official_title>Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male (ADAM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comenius University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian School of Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slovak Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Comenius University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines the effect of 12-week strength training program with and without&#xD;
      testosterone replacement therapy (TRT) on body composition, physical function, selected&#xD;
      biochemical markers of metabolic health, molecular parameters of training adaptation and the&#xD;
      quality of life patients with ADAM. The investigators believe, that strength training program&#xD;
      performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and&#xD;
      gain lean mass), muscle strength, muscle power and general quality of life in all training&#xD;
      groups. In addition, combination TRT and strength training could help decrease fat mass,&#xD;
      improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for&#xD;
      hypogonadal ageing males.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is 3 groups controlled 12-week study to assess the effect of testosterone&#xD;
      replacement therapy (TRT) with strength training (ST) and strength training (ST) for&#xD;
      hypogonadal participants without testosterone replacement therapy (NON-TRT) with control&#xD;
      healthy eugonadal group, that is also engaged in strength training.&#xD;
&#xD;
      Strength training protocol starts one week after all the pre-intervention testing. The&#xD;
      intervention is performed at the Comenius University in Bratislava, Faculty of Physical&#xD;
      Education and Sport (FSPORT CU) in Slovakia. The strength training protocol follows a&#xD;
      modified resistance exercise program. The participants perform strength training sessions two&#xD;
      times per week for 12 weeks. All training sessions are supervised and guided by professional&#xD;
      coaches with university degree in sports training to ensure safety, technique and progression&#xD;
      in training load, with a maximum of three participants per coach.&#xD;
&#xD;
      Each training session include 5-minute general dynamic warm-up followed by progressive&#xD;
      strength training with exercises for the entire body. The strength exercises are performed&#xD;
      with free weights and on machines. The training program consist of 6 exercises for upper and&#xD;
      lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in&#xD;
      eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes.&#xD;
      The participants are instructed to perform concentric action in 2 s and immediately after&#xD;
      eccentric action in also 2 s. The exercises performed are: leg press, split squats, bench&#xD;
      press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell&#xD;
      bench press, incline dumbbell bench press. Training equipment is provided by KOHI Leopoldov,&#xD;
      Slovakia and Technogym, Italia.&#xD;
&#xD;
      Clinical and muscle cellular outcomes are collected before the intervention (pre-testing&#xD;
      assessments) and after the intervention (post-testing assessments). Post intervention&#xD;
      measurements start 7 days after intervention and go up to 3 weeks after intervention.&#xD;
&#xD;
      Clinical outcomes Body composition analysis is measured by Dual-energy X-ray Absorptiometry&#xD;
      using Hologic fan-beam bone densitometer Discovery QDR series. LBM(lean body mass) is&#xD;
      measured in total body and separately for arms, legs and trunk. The changes in lower and&#xD;
      upper body LBM are investigated separately because of differences in androgen sensitivity in&#xD;
      leg muscles compared to neck, chest and shoulder muscles. Body weight is measured by&#xD;
      bioimpedance scale, the height by stadiometer and waist circumference by tape. The body mass&#xD;
      index is calculated.&#xD;
&#xD;
      Biochemical outcomes Fasting morning venous blood is taken from 8:00 am to 10:00 am. The&#xD;
      haematological and biochemical parameters analysed are Haemoglobin, hematocrits, leucocytes,&#xD;
      thrombocytes, glucose, urea, sodium, potassium, calcium, ALAT, total cholesterol, LDL&#xD;
      cholesterol, HDL cholesterol, triglyceride, testosterone, oestrogen, LH, FSH, SHBG, albumin,&#xD;
      bilirubin, total protein, CRP, insulin, PSA.&#xD;
&#xD;
      Physical functioning Muscle strength is measured by novel portable isometric knee dynamometer&#xD;
      (maximal voluntary contraction of isometric knee extension, isometric knee flexion), hand&#xD;
      grip strength dynamometry by Camry Digital Hand Dynamometer, predicted 1RM leg press from&#xD;
      multiple repetition maximum testing. Cardio-respiratory fitness is measured by The Single&#xD;
      Stage Treadmill Walking Test on Woodway Pro Treadmill, 10-m fast walk and 10-m usual walk&#xD;
      measured by Photocells.&#xD;
&#xD;
      Quality of life The general health status is measured by The Short Form (36) Health Survey&#xD;
      patient-reported survey of patient health (SF-36). In addition to that clinically&#xD;
      investigating the health-related quality of life (HRQoL) and symptoms of aging men are&#xD;
      measured by Aging Males' Symptom Scale (AMS).&#xD;
&#xD;
      Muscle cellular outcomes Muscle biopsies are obtain from approximately 80% of the subjects&#xD;
      included in the study. Participants not willing to undergo biopsy are still eligible for&#xD;
      trial participation.&#xD;
&#xD;
      With the participant in a supine position, a 5 mm Muscle Biopsy Cannula (Bergstrom-stille,&#xD;
      Sweden) with manual suction is used to obtain muscle samples (200 mg), under local&#xD;
      anaesthesia (Lidocain 2%,). Before the intervention the biopsy is obtained from the&#xD;
      mid-section of the right musculus vastus lateralis, and after the intervention the biopsy is&#xD;
      obtained 3 cm proximal to the pre-intervention biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is 3 arms 12-week strength training program to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal patients without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Lean Mass</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fat Mass</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Body Mass</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 10-m Usual Walk Test</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured in seconds by Microgates Photocells and than calculated to meters per second.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 10-m Fast Walk Test</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured in seconds by Microgates Photocells than calculated to meters per second</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Handgrip Strength</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured by Camry Digital Hand Dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured by Portable Isometric Knee Dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured by Portable Isometric Knee Dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in The Single Stage Treadmill Walking Test</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Predicted One Repetition Maximum on Leg Press</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Maximal Voluntary Contraction in Benchpress</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measured in N by FiTRO Force Plates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in The Short Form Health Survey (SF-36)</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Aging Males' Symptom (AMS) Scale</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Measuring symptoms of ageing men by numeric score scale.&#xD;
The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire).&#xD;
The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Metabolic Parameters</measure>
    <time_frame>7 days before intervention, 7 days after intervention</time_frame>
    <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Liver Function Blood Parameters</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hormonal Parameters</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ions</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CRP</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Muscle Fiber Size</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Muscle fiber size measured in um2. Analysis of the date are in progress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Regulators of Muscle Fiber Size</measure>
    <time_frame>7 days before intervention, 14 days after intervention</time_frame>
    <description>Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy. Analysis of the date are in progress.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Hypogonadism, Male</condition>
  <condition>Physical Activity</condition>
  <condition>Testosterone Deficiency</condition>
  <arm_group>
    <arm_group_label>hypogonadal males without TRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypogonadal males with TRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Strength training and regular prescribed testosterone therapy given by participant urologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy eugonadal males</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Strength training</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <description>The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
    <arm_group_label>healthy eugonadal males</arm_group_label>
    <arm_group_label>hypogonadal males with TRT</arm_group_label>
    <arm_group_label>hypogonadal males without TRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of secondary hypogonadism on testosterone replacement therapy, newly&#xD;
             diagnosed patients of secondary hypogonadism.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular strength training, medical treating osteoporosis, abnormal digital rectal&#xD;
             results, conditions which are medical contraindications (without adjusting state):&#xD;
             diabetes mellitus, severe cardiac arrhythmia, uncontrolled hypertension, unstable&#xD;
             angina pectoris, chronic obstructive pulmonary disease, epilepsy, unstable bone&#xD;
             lesions with high risk of fracture, prostate cancer or abnormal serum PSA levels&#xD;
             without adverse histological examination.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Milan Sedliak, assoc. prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Comenius University of Bratislava, Faculty Physical Education and Sport</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comenius University in Bratislava, Faculty of physical education and sport</name>
      <address>
        <city>Bratislava</city>
        <zip>814 69</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovakia</country>
  </location_countries>
  <results_reference>
    <citation>Basaria S. Androgen deprivation therapy, insulin resistance, and cardiovascular mortality: an inconvenient truth. J Androl. 2008 Sep-Oct;29(5):534-9. doi: 10.2164/jandrol.108.005454. Epub 2008 Jun 20.</citation>
    <PMID>18567642</PMID>
  </results_reference>
  <results_reference>
    <citation>Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress ME, Ballard R, Schwartz RS. Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels. J Clin Endocrinol Metab. 2013 May;98(5):1891-900. doi: 10.1210/jc.2013-2227. Epub 2013 Mar 26.</citation>
    <PMID>23533227</PMID>
  </results_reference>
  <results_reference>
    <citation>Schwarz ER, Willix RD Jr. Impact of a physician-supervised exercise-nutrition program with testosterone substitution in partial androgen-deficient middle-aged obese men. J Geriatr Cardiol. 2011 Dec;8(4):201-6. doi: 10.3724/SP.J.1263.2011.00201.</citation>
    <PMID>22783306</PMID>
  </results_reference>
  <results_reference>
    <citation>Kadi F, Bonnerud P, Eriksson A, Thornell LE. The expression of androgen receptors in human neck and limb muscles: effects of training and self-administration of androgenic-anabolic steroids. Histochem Cell Biol. 2000 Jan;113(1):25-9. doi: 10.1007/s004180050003.</citation>
    <PMID>10664066</PMID>
  </results_reference>
  <results_reference>
    <citation>Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16.</citation>
    <PMID>24344218</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <results_first_submitted>February 23, 2020</results_first_submitted>
  <results_first_submitted_qc>April 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2020</results_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Comenius University</investigator_affiliation>
    <investigator_full_name>Milan Sedliak</investigator_full_name>
    <investigator_title>Independent researcher, Vice-dean for science, research and international cooperation</investigator_title>
  </responsible_party>
  <keyword>hypogonadism</keyword>
  <keyword>aging male</keyword>
  <keyword>strength training</keyword>
  <keyword>physical activity</keyword>
  <keyword>testosterone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
    <mesh_term>Eunuchism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03282682/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hypogonadal Males Without TRT</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="P2">
          <title>Hypogonadal Males With TRT</title>
          <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="P3">
          <title>Healthy Eugonadal Males</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hypogonadal Males Without TRT</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="B2">
          <title>Hypogonadal Males With TRT</title>
          <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="B3">
          <title>Healthy Eugonadal Males</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.41" spread="7.9"/>
                    <measurement group_id="B2" value="43.03" spread="2.9"/>
                    <measurement group_id="B3" value="50.11" spread="5.1"/>
                    <measurement group_id="B4" value="47.07" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Slovak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Lean Mass</title>
        <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lean Mass</title>
          <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2734" spread="1967"/>
                    <measurement group_id="O2" value="499" spread="1566"/>
                    <measurement group_id="O3" value="2268" spread="2609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fat Mass</title>
        <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fat Mass</title>
          <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1969" spread="2526"/>
                    <measurement group_id="O2" value="-1263" spread="1920"/>
                    <measurement group_id="O3" value="-755" spread="1514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Body Mass</title>
        <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Body Mass</title>
          <description>Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.</description>
          <units>grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="621.53" spread="2922.45"/>
                    <measurement group_id="O2" value="-821.73" spread="3279.29"/>
                    <measurement group_id="O3" value="1435.04" spread="3655.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 10-m Usual Walk Test</title>
        <description>Measured in seconds by Microgates Photocells and than calculated to meters per second.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 10-m Usual Walk Test</title>
          <description>Measured in seconds by Microgates Photocells and than calculated to meters per second.</description>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0.089"/>
                    <measurement group_id="O2" value="-0.06" spread="0.146"/>
                    <measurement group_id="O3" value="-0.05" spread="0.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 10-m Fast Walk Test</title>
        <description>Measured in seconds by Microgates Photocells than calculated to meters per second</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 10-m Fast Walk Test</title>
          <description>Measured in seconds by Microgates Photocells than calculated to meters per second</description>
          <units>m/s</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.255"/>
                    <measurement group_id="O2" value="-0.1" spread="0.172"/>
                    <measurement group_id="O3" value="-0.13" spread="0.253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Handgrip Strength</title>
        <description>Measured by Camry Digital Hand Dynamometer.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Handgrip Strength</title>
          <description>Measured by Camry Digital Hand Dynamometer.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.41" spread="4.00"/>
                    <measurement group_id="O2" value="0.84" spread="2.12"/>
                    <measurement group_id="O3" value="-0.02" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension</title>
        <description>Measured by Portable Isometric Knee Dynamometer.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension</title>
          <description>Measured by Portable Isometric Knee Dynamometer.</description>
          <units>Nm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.65" spread="93.44"/>
                    <measurement group_id="O2" value="8.15" spread="28.97"/>
                    <measurement group_id="O3" value="1.35" spread="69.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion</title>
        <description>Measured by Portable Isometric Knee Dynamometer.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion</title>
          <description>Measured by Portable Isometric Knee Dynamometer.</description>
          <units>Nm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.32" spread="27.89"/>
                    <measurement group_id="O2" value="24.64" spread="36.09"/>
                    <measurement group_id="O3" value="14.36" spread="28.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in The Single Stage Treadmill Walking Test</title>
        <description>This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in The Single Stage Treadmill Walking Test</title>
          <description>This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.</description>
          <units>ml.kg-1.min-1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.64"/>
                    <measurement group_id="O2" value="0.25" spread="0.64"/>
                    <measurement group_id="O3" value="0.42" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Predicted One Repetition Maximum on Leg Press</title>
        <description>One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Predicted One Repetition Maximum on Leg Press</title>
          <description>One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.31" spread="28.39"/>
                    <measurement group_id="O2" value="51.59" spread="34.43"/>
                    <measurement group_id="O3" value="51.40" spread="27.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Maximal Voluntary Contraction in Benchpress</title>
        <description>Measured in N by FiTRO Force Plates.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Maximal Voluntary Contraction in Benchpress</title>
          <description>Measured in N by FiTRO Force Plates.</description>
          <units>N</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.49" spread="147.12"/>
                    <measurement group_id="O2" value="64.31" spread="143.29"/>
                    <measurement group_id="O3" value="66.68" spread="103.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in The Short Form Health Survey (SF-36)</title>
        <description>Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in The Short Form Health Survey (SF-36)</title>
          <description>Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="9.87"/>
                    <measurement group_id="O2" value="7.50" spread="18.52"/>
                    <measurement group_id="O3" value="3.75" spread="12.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Aging Males' Symptom (AMS) Scale</title>
        <description>Measuring symptoms of ageing men by numeric score scale.&#xD;
The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire).&#xD;
The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Aging Males' Symptom (AMS) Scale</title>
          <description>Measuring symptoms of ageing men by numeric score scale.&#xD;
The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire).&#xD;
The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.83" spread="7.41"/>
                    <measurement group_id="O2" value="-2.00" spread="5.98"/>
                    <measurement group_id="O3" value="-6.25" spread="5.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Metabolic Parameters</title>
        <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
        <time_frame>7 days before intervention, 7 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Metabolic Parameters</title>
          <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>S-Bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0006" spread="0.0038"/>
                    <measurement group_id="O2" value="0.0008" spread="0.004"/>
                    <measurement group_id="O3" value="-0.003" spread="0.006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.008"/>
                    <measurement group_id="O2" value="-0.0002" spread="0.0052"/>
                    <measurement group_id="O3" value="0.0011" spread="0.0038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.44"/>
                    <measurement group_id="O2" value="0.29" spread="0.50"/>
                    <measurement group_id="O3" value="-0.02" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Total Cholesterol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.67"/>
                    <measurement group_id="O2" value="0.22" spread="0.71"/>
                    <measurement group_id="O3" value="0.29" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-HDL Cholesterol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.10"/>
                    <measurement group_id="O2" value="0.09" spread="0.17"/>
                    <measurement group_id="O3" value="0.08" spread="0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-LDL Cholesterol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.52"/>
                    <measurement group_id="O2" value="-0.30" spread="1.07"/>
                    <measurement group_id="O3" value="-0.12" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Triglyceride</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="0.46"/>
                    <measurement group_id="O2" value="0.38" spread="1.27"/>
                    <measurement group_id="O3" value="0.28" spread="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Urea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="1.45"/>
                    <measurement group_id="O2" value="3.77" spread="8.58"/>
                    <measurement group_id="O3" value="0.84" spread="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Uric Acid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.016" spread="0.071"/>
                    <measurement group_id="O2" value="0.004" spread="0.047"/>
                    <measurement group_id="O3" value="-0.010" spread="0.053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Liver Function Blood Parameters</title>
        <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Liver Function Blood Parameters</title>
          <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
          <units>µkat/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>S-ALP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.11"/>
                    <measurement group_id="O2" value="0.05" spread="0.11"/>
                    <measurement group_id="O3" value="0.10" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.49"/>
                    <measurement group_id="O2" value="-0.05" spread="0.28"/>
                    <measurement group_id="O3" value="-0.07" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-AMS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.23"/>
                    <measurement group_id="O2" value="0.05" spread="0.08"/>
                    <measurement group_id="O3" value="0.07" spread="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-AST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.19"/>
                    <measurement group_id="O2" value="0.00" spread="0.19"/>
                    <measurement group_id="O3" value="-0.01" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-GMT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.23"/>
                    <measurement group_id="O2" value="0.01" spread="0.16"/>
                    <measurement group_id="O3" value="-0.05" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hormonal Parameters</title>
        <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hormonal Parameters</title>
          <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
          <units>nmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>S-Testosterone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="1.20"/>
                    <measurement group_id="O2" value="-0.50" spread="3.51"/>
                    <measurement group_id="O3" value="-1.99" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-SHBG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" spread="4.67"/>
                    <measurement group_id="O2" value="-1.35" spread="6.10"/>
                    <measurement group_id="O3" value="-2.93" spread="6.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Cortisol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.93" spread="103.28"/>
                    <measurement group_id="O2" value="-44.60" spread="140.83"/>
                    <measurement group_id="O3" value="34.34" spread="159.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Insuline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004" spread="0.046"/>
                    <measurement group_id="O2" value="0.019" spread="0.061"/>
                    <measurement group_id="O3" value="0.006" spread="0.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ions</title>
        <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ions</title>
          <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
          <units>mmol/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>S-Chlorides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.47" spread="2.50"/>
                    <measurement group_id="O2" value="-0.77" spread="4.21"/>
                    <measurement group_id="O3" value="-0.33" spread="3.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Potassium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.34"/>
                    <measurement group_id="O2" value="0.06" spread="0.13"/>
                    <measurement group_id="O3" value="0.14" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>S-Sodium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="1.26"/>
                    <measurement group_id="O2" value="-0.15" spread="1.31"/>
                    <measurement group_id="O3" value="-0.19" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CRP</title>
        <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hypogonadal Males Without TRT</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O2">
            <title>Hypogonadal Males With TRT</title>
            <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
          <group group_id="O3">
            <title>Healthy Eugonadal Males</title>
            <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CRP</title>
          <description>Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG &amp; Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.</description>
          <units>mg/l</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="9.40"/>
                    <measurement group_id="O2" value="0.13" spread="2.26"/>
                    <measurement group_id="O3" value="-1.67" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Muscle Fiber Size</title>
        <description>Muscle fiber size measured in um2. Analysis of the date are in progress.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <posting_date>12/2021</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Regulators of Muscle Fiber Size</title>
        <description>Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy. Analysis of the date are in progress.</description>
        <time_frame>7 days before intervention, 14 days after intervention</time_frame>
        <posting_date>12/2021</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>This type of supervised exercise interventions are very well-tolerated and no major risks and all-cause mortalities are expected. The intervention protocol was also well-tolerated, well-attended, with exercise session attendance approximately 90%, without any serious adverse events during the intervention, when supervised and controlled by specialists trained in this field.</desc>
      <group_list>
        <group group_id="E1">
          <title>Hypogonadal Males Without TRT</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="E2">
          <title>Hypogonadal Males With TRT</title>
          <description>Strength training and regular prescribed testosterone therapy given by participant urologist.&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
        <group group_id="E3">
          <title>Healthy Eugonadal Males</title>
          <description>Strength training&#xD;
Strength training: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The major limit of the study was low number of the newly diagnosed patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Doc. Mgr. Milan Sedliak, PhD.</name_or_title>
      <organization>Comenius University in Bratislava</organization>
      <phone>+421918340671</phone>
      <email>milan.sedliak@uniba.sk</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03282682
org study id: FSPORT-CU-ADAM
nct id: NCT03282682
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines the effect of 12-week strength training program with and without
      testosterone replacement therapy (TRT) on body composition, physical function, selected
      biochemical markers of metabolic health, molecular parameters of training adaptation and the
      quality of life patients with ADAM. The investigators believe, that strength training program
      performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and
      gain lean mass), muscle strength, muscle power and general quality of life in all training
      groups. In addition, combination TRT and strength training could help decrease fat mass,
      improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for
      hypogonadal ageing males.
The study is 3 groups controlled 12-week study to assess the effect of testosterone
      replacement therapy (TRT) with strength training (ST) and strength training (ST) for
      hypogonadal participants without testosterone replacement therapy (NON-TRT) with control
      healthy eugonadal group, that is also engaged in strength training.

      Strength training protocol starts one week after all the pre-intervention testing. The
      intervention is performed at the Comenius University in Bratislava, Faculty of Physical
      Education and Sport (FSPORT CU) in Slovakia. The strength training protocol follows a
      modified resistance exercise program. The participants perform strength training sessions two
      times per week for 12 weeks. All training sessions are supervised and guided by professional
      coaches with university degree in sports training to ensure safety, technique and progression
      in training load, with a maximum of three participants per coach.

      Each training session include 5-minute general dynamic warm-up followed by progressive
      strength training with exercises for the entire body. The strength exercises are performed
      with free weights and on machines. The training program consist of 6 exercises for upper and
      lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in
      eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes.
      The participants are instructed to perform concentric action in 2 s and immediately after
      eccentric action in also 2 s. The exercises performed are: leg press, split squats, bench
      press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell
      bench press, incline dumbbell bench press. Training equipment is provided by KOHI Leopoldov,
      Slovakia and Technogym, Italia.

      Clinical and muscle cellular outcomes are collected before the intervention (pre-testing
      assessments) and after the intervention (post-testing assessments). Post intervention
      measurements start 7 days after intervention and go up to 3 weeks after intervention.

      Clinical outcomes Body composition analysis is measured by Dual-energy X-ray Absorptiometry
      using Hologic fan-beam bone densitometer Discovery QDR series. LBM(lean body mass) is
      measured in total body and separately for arms, legs and trunk. The changes in lower and
      upper body LBM are investigated separately because of differences in androgen sensitivity in
      leg muscles compared to neck, chest and shoulder muscles. Body weight is measured by
      bioimpedance scale, the height by stadiometer and waist circumference by tape. The body mass
      index is calculated.

      Biochemical outcomes Fasting morning venous blood is taken from 8:00 am to 10:00 am. The
      haematological and biochemical parameters analysed are Haemoglobin, hematocrits, leucocytes,
      thrombocytes, glucose, urea, sodium, potassium, calcium, ALAT, total cholesterol, LDL
      cholesterol, HDL cholesterol, triglyceride, testosterone, oestrogen, LH, FSH, SHBG, albumin,
      bilirubin, total protein, CRP, insulin, PSA.

      Physical functioning Muscle strength is measured by novel portable isometric knee dynamometer
      (maximal voluntary contraction of isometric knee extension, isometric knee flexion), hand
      grip strength dynamometry by Camry Digital Hand Dynamometer, predicted 1RM leg press from
      multiple repetition maximum testing. Cardio-respiratory fitness is measured by The Single
      Stage Treadmill Walking Test on Woodway Pro Treadmill, 10-m fast walk and 10-m usual walk
      measured by Photocells.

      Quality of life The general health status is measured by The Short Form (36) Health Survey
      patient-reported survey of patient health (SF-36). In addition to that clinically
      investigating the health-related quality of life (HRQoL) and symptoms of aging men are
      measured by Aging Males' Symptom Scale (AMS).

      Muscle cellular outcomes Muscle biopsies are obtain from approximately 80% of the subjects
      included in the study. Participants not willing to undergo biopsy are still eligible for
      trial participation.

      With the participant in a supine position, a 5 mm Muscle Biopsy Cannula (Bergstrom-stille,
      Sweden) with manual suction is used to obtain muscle samples (200 mg), under local
      anaesthesia (Lidocain 2%,). Before the intervention the biopsy is obtained from the
      mid-section of the right musculus vastus lateralis, and after the intervention the biopsy is
      obtained 3 cm proximal to the pre-intervention biopsy.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The study is 3 arms 12-week strength training program to assess the effect of testosterone replacement therapy (TRT) with strength training (ST) and strength training (ST) for hypogonadal patients without testosterone replacement therapy (NON-TRT) with control healthy eugonadal group, that is also engaged in strength training.
primary purpose: Basic Science
masking: None (Open Label)
measure: Change From Baseline in Lean Mass
time frame: 7 days before intervention, 7 days after intervention
description: Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
measure: Change From Baseline in Fat Mass
time frame: 7 days before intervention, 7 days after intervention
description: Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
measure: Change From Baseline in Total Body Mass
time frame: 7 days before intervention, 7 days after intervention
description: Total body by Dual-energy X-ray Absorptiometry using Hologic fan-beam bone densitometer Discovery QDR series.
measure: Change From Baseline in 10-m Usual Walk Test
time frame: 7 days before intervention, 7 days after intervention
description: Measured in seconds by Microgates Photocells and than calculated to meters per second.
measure: Change From Baseline in 10-m Fast Walk Test
time frame: 7 days before intervention, 7 days after intervention
description: Measured in seconds by Microgates Photocells than calculated to meters per second
measure: Change From Baseline in Handgrip Strength
time frame: 7 days before intervention, 7 days after intervention
description: Measured by Camry Digital Hand Dynamometer.
measure: Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Extension
time frame: 7 days before intervention, 7 days after intervention
description: Measured by Portable Isometric Knee Dynamometer.
measure: Change From Baseline in Maximal Voluntary Contraction (MVC) of Isometric Knee Flexion
time frame: 7 days before intervention, 7 days after intervention
description: Measured by Portable Isometric Knee Dynamometer.
measure: Change From Baseline in The Single Stage Treadmill Walking Test
time frame: 7 days before intervention, 7 days after intervention
description: This test is focused on calculated VO2max in ml.kg-1.min-1 from speed measured on Woodway Pro Treadmill.
measure: Change From Baseline in Predicted One Repetition Maximum on Leg Press
time frame: 7 days before intervention, 7 days after intervention
description: One repetition maximum in kg on leg press is predicted from multiple repetition maximum testing and measured on Life Fitness Signature Series Leg Press machine.
measure: Change From Baseline in Maximal Voluntary Contraction in Benchpress
time frame: 7 days before intervention, 7 days after intervention
description: Measured in N by FiTRO Force Plates.
measure: Change From Baseline in The Short Form Health Survey (SF-36)
time frame: 7 days before intervention, 7 days after intervention
description: Patient-reported survey of patient health (SF-36), clinically investigating the health-related quality of life (HRQoL). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score.
measure: Change From Baseline in Aging Males' Symptom (AMS) Scale
time frame: 7 days before intervention, 7 days after intervention
description: Measuring symptoms of ageing men by numeric score scale.
The questionnaire has for each of the 17 item an option to check one of 5 degrees of severity (severity 1...5 points at the questionnaire).
The composite scores for each of the three dimensions (sub-scales) is based on adding up the scores of the items of the respective dimensions. The composite score (total score) is the sum of the three dimension scores. Higher score means higher severity of symptoms. The minimum total score is 17 and the maximum is 85.
measure: Change From Baseline in Metabolic Parameters
time frame: 7 days before intervention, 7 days after intervention
description: Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
measure: Change From Baseline in Liver Function Blood Parameters
time frame: 7 days before intervention, 14 days after intervention
description: Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
measure: Change From Baseline in Hormonal Parameters
time frame: 7 days before intervention, 14 days after intervention
description: Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
measure: Change From Baseline in Ions
time frame: 7 days before intervention, 14 days after intervention
description: Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
measure: Change From Baseline in CRP
time frame: 7 days before intervention, 14 days after intervention
description: Fasting morning venous blood was taken after overnight (10-hour) fasting and 15 min rest from cubital vein from 8:00 am to 10:00 am [69] into closed system collection tubes containing beads coated with a clotting activator and polyacryl ester-gel (Sarstedt AG & Co, Germany). The blood will be centrifuged (3000g, 4°C, 10min) immediately after sampling to obtain EDTA plasma or they will be centrifuged (3000g, 4°C, 20min) after 30min at RT, to obtain serum.
measure: Change From Baseline in Muscle Fiber Size
time frame: 7 days before intervention, 14 days after intervention
description: Muscle fiber size measured in um2. Analysis of the date are in progress.
measure: Change From Baseline in Regulators of Muscle Fiber Size
time frame: 7 days before intervention, 14 days after intervention
description: Regulators of muscle fiber size - number of myonuclei per muscle fiber, number of satellite cells per muscle fiber, number of satellite cells and myonuclei positive for androgen receptors, proteins involved in muscle hypertrophy. Analysis of the date are in progress.
arm group label: hypogonadal males without TRT
arm group type: Experimental
description: Strength training
arm group label: hypogonadal males with TRT
arm group type: Experimental
description: Strength training and regular prescribed testosterone therapy given by participant urologist.
arm group label: healthy eugonadal males
arm group type: Active Comparator
description: Strength training
intervention type: Procedure
intervention name: Strength training
description: The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.
arm group label: healthy eugonadal males
arm group label: hypogonadal males with TRT
arm group label: hypogonadal males without TRT
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Milan Sedliak, assoc. prof.
role: Principal Investigator
affiliation: Comenius University of Bratislava, Faculty Physical Education and Sport
facility: 
country: Slovakia
citation: Basaria S. Androgen deprivation therapy, insulin resistance, and cardiovascular mortality: an inconvenient truth. J Androl. 2008 Sep-Oct;29(5):534-9. doi: 10.2164/jandrol.108.005454. Epub 2008 Jun 20.
PMID: 18567642
citation: Hildreth KL, Barry DW, Moreau KL, Vande Griend J, Meacham RB, Nakamura T, Wolfe P, Kohrt WM, Ruscin JM, Kittelson J, Cress ME, Ballard R, Schwartz RS. Effects of testosterone and progressive resistance exercise in healthy, highly functioning older men with low-normal testosterone levels. J Clin Endocrinol Metab. 2013 May;98(5):1891-900. doi: 10.1210/jc.2013-2227. Epub 2013 Mar 26.
PMID: 23533227
citation: Schwarz ER, Willix RD Jr. Impact of a physician-supervised exercise-nutrition program with testosterone substitution in partial androgen-deficient middle-aged obese men. J Geriatr Cardiol. 2011 Dec;8(4):201-6. doi: 10.3724/SP.J.1263.2011.00201.
PMID: 22783306
citation: Kadi F, Bonnerud P, Eriksson A, Thornell LE. The expression of androgen receptors in human neck and limb muscles: effects of training and self-administration of androgenic-anabolic steroids. Histochem Cell Biol. 2000 Jan;113(1):25-9. doi: 10.1007/s004180050003.
PMID: 10664066
citation: Gardner JR, Livingston PM, Fraser SF. Effects of exercise on treatment-related adverse effects for patients with prostate cancer receiving androgen-deprivation therapy: a systematic review. J Clin Oncol. 2014 Feb 1;32(4):335-46. doi: 10.1200/JCO.2013.49.5523. Epub 2013 Dec 16.
PMID: 24344218
responsible party type: Principal Investigator
investigator affiliation: Comenius University
investigator full name: Milan Sedliak
investigator title: Independent researcher, Vice-dean for science, research and international cooperation
mesh term: Hypogonadism
mesh term: Eunuchism
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The major limit of the study was low number of the newly diagnosed patients.
point of contact: 