xml: <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/NCT05985616</url>
    </required_header>
    <id_info>
      <org_study_id>REC01549 Shanza Nisar</org_study_id>
      <nct_id>NCT05985616</nct_id>
    </id_info>
    <brief_title>High Intensity Resistance Training and Possible Sarcopenia</brief_title>
    <official_title>Effects of High Intensity Resistance Training on Physical Function in Possible Sarcopenia Cases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International 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>
        Studies conducted so far added the dietary supplements along with resistance training as an&#xD;
        intervention, we could not determine whether the observed effects of the intervention were&#xD;
        due to the training program and/or dietary supplements.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will investigate the effects of high intensity resistance training solely in the&#xD;
        possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this&#xD;
        study will help clinicians to individualize and optimize the therapy for specific patient&#xD;
        subgroups, improve the potential of this therapy to improve human function and well being,&#xD;
        facilitate timely interventions in community healthcare and prevention settings, which will&#xD;
        contribute to higher awareness of sarcopenia prevention and interventions in diverse health&#xD;
        care settings.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Hand Dynamometer</measure>
      <time_frame>16 weeks</time_frame>
      <description>it used to measure the hand grip strength. the test-retest reliability is 0.91 and 0.95 with excellent reliability. The assessment will be made at baseline, week 8 and 16</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short performance physical battery</measure>
      <time_frame>16 Week</time_frame>
      <description>an objective assessment tool for evaluating lower extremity functioning in older persons. the test-retest reliability is 0.87. It was used to measure at baseline, week 8 and 16</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>FRAIL</measure>
      <time_frame>16 week</time_frame>
      <description>The questionnaire aims at fatigue, resistance, ambulation, illness and loss of weight. It is a self reported questionnaire. The sensitivity of FRAIL is 85.8% and a specificity of 80.6%.&#xD;
  The test will be measured at baseline, week 8 and 16</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Sarcopenia</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>High intensity (80-85% of 1RM) will be administered at alternative days for 16 weeks.&#xD;
  The exercise will have three phases; Phase I consists of 2-3 sets of 8-15 repetitions, Phase II will follow the single set approach and Phase III will have the Superset approach.&#xD;
  The following activities will be incorporated via resistance training: latissimus front pulleys, rowing, back extension, inverse fly, bench press, shoulder press, lateral raises, butterfly with extended arms, crunches, leg presses, leg extension and curls, leg adduction, abduction.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be provided in this group. The participants in this group will follow their usual daily activities.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>High Intensity Resistance Training</intervention_name>
      <description>High intensity resistance training will be performed 3 times a day for sixteen weeks</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both male and female&#xD;
  &#xD;
            -  Age more than 60 years&#xD;
  &#xD;
            -  Possible sarcopenia cases as defined by Asian Working Group for Sarcopenia (Handgrip&#xD;
               strength: Male less than 26kg and Female less than 18kg, 5 time chair stand test more&#xD;
               than/equals to 12 seconds)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Orthopedic surgery in last one year&#xD;
  &#xD;
            -  Neurological disorders like stroke etc&#xD;
  &#xD;
            -  History of recent fractures&#xD;
  &#xD;
            -  Metabolic disorders like DM etc&#xD;
  &#xD;
            -  Actively involved in exercise programs&#xD;
  &#xD;
            -  Cognitive impairment that could confound the assessment&#xD;
  &#xD;
            -  Wheelchair or bed bound individuals&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mirza Obaid Baig, MSPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shanza Nisar, DPT</last_name>
      <phone>0092 342 5744870</phone>
      <email>shanzahnisar@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mirza Obaid Baig, MSPT</last_name>
      <phone>00923332238706</phone>
      <email>obaid.baig@riphah.edu.pk</email>
    </overall_contact_backup>
    <reference>
      <citation>Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.</citation>
      <PMID>32270891</PMID>
    </reference>
    <reference>
      <citation>Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.</citation>
      <PMID>24864078</PMID>
    </reference>
    <reference>
      <citation>Abdul-Hameed U, Rangra P, Shareef MY, Hussain ME. Reliability of 1-repetition maximum estimation for upper and lower body muscular strength measurement in untrained middle aged type 2 diabetic patients. Asian J Sports Med. 2012 Dec;3(4):267-73. doi: 10.5812/asjsm.34549.</citation>
      <PMID>23342225</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985616
  org study id: REC01549 Shanza Nisar
  nct id: NCT05985616
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Studies conducted so far added the dietary supplements along with resistance training as an
        intervention, we could not determine whether the observed effects of the intervention were
        due to the training program and/or dietary supplements.
  This study will investigate the effects of high intensity resistance training solely in the
        possible sarcopenia cases which has not done before, to author's knowledge. Furthermore this
        study will help clinicians to individualize and optimize the therapy for specific patient
        subgroups, improve the potential of this therapy to improve human function and well being,
        facilitate timely interventions in community healthcare and prevention settings, which will
        contribute to higher awareness of sarcopenia prevention and interventions in diverse health
        care settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Hand Dynamometer
  time frame: 16 weeks
  description: it used to measure the hand grip strength. the test-retest reliability is 0.91 and 0.95 with excellent reliability. The assessment will be made at baseline, week 8 and 16
  measure: Short performance physical battery
  time frame: 16 Week
  description: an objective assessment tool for evaluating lower extremity functioning in older persons. the test-retest reliability is 0.87. It was used to measure at baseline, week 8 and 16
  measure: FRAIL
  time frame: 16 week
  description: The questionnaire aims at fatigue, resistance, ambulation, illness and loss of weight. It is a self reported questionnaire. The sensitivity of FRAIL is 85.8% and a specificity of 80.6%.
  The test will be measured at baseline, week 8 and 16
  arm group label: Group A
  arm group type: Experimental
  description: High intensity (80-85% of 1RM) will be administered at alternative days for 16 weeks.
  The exercise will have three phases; Phase I consists of 2-3 sets of 8-15 repetitions, Phase II will follow the single set approach and Phase III will have the Superset approach.
  The following activities will be incorporated via resistance training: latissimus front pulleys, rowing, back extension, inverse fly, bench press, shoulder press, lateral raises, butterfly with extended arms, crunches, leg presses, leg extension and curls, leg adduction, abduction.
  arm group label: Group B
  arm group type: No Intervention
  description: No intervention will be provided in this group. The participants in this group will follow their usual daily activities.
  intervention type: Other
  intervention name: High Intensity Resistance Training
  description: High intensity resistance training will be performed 3 times a day for sixteen weeks
  arm group label: Group A
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mirza Obaid Baig, MSPT
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Shanza Nisar, DPT
  phone: 0092 342 5744870
  email: shanzahnisar@gmail.com
  last name: Mirza Obaid Baig, MSPT
  phone: 00923332238706
  email: obaid.baig@riphah.edu.pk
  citation: Kemmler W, Kohl M, Frohlich M, Jakob F, Engelke K, von Stengel S, Schoene D. Effects of High-Intensity Resistance Training on Osteopenia and Sarcopenia Parameters in Older Men with Osteosarcopenia-One-Year Results of the Randomized Controlled Franconian Osteopenia and Sarcopenia Trial (FrOST). J Bone Miner Res. 2020 Sep;35(9):1634-1644. doi: 10.1002/jbmr.4027. Epub 2020 Apr 28.
  PMID: 32270891
  citation: Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.
  PMID: 24864078
  citation: Abdul-Hameed U, Rangra P, Shareef MY, Hussain ME. Reliability of 1-repetition maximum estimation for upper and lower body muscular strength measurement in untrained middle aged type 2 diabetic patients. Asian J Sports Med. 2012 Dec;3(4):267-73. doi: 10.5812/asjsm.34549.
  PMID: 23342225
  responsible party type: Sponsor
  mesh term: Sarcopenia
  sharing ipd: No