<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/NCT03287284</url>
  </required_header>
  <id_info>
    <org_study_id>59328316.9.0000.5345</org_study_id>
    <nct_id>NCT03287284</nct_id>
  </id_info>
  <brief_title>Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity</brief_title>
  <official_title>Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Health Science of Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Health Science of Porto Alegre</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phototherapy has been largely used in rehabilitation programs due to its analgesic,&#xD;
      antiinflammatory and healing effects. Lately, its effects of optimizing the results of&#xD;
      resistance training on young individuals have been studied. However, there is a lack of&#xD;
      studies on its effect on the elderly population. The objective of the present study is to&#xD;
      verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in&#xD;
      the elderly. The study will be a randomized doubled-blinded controlled trial. 30 elderly men&#xD;
      with age ranging from 60 to 80 years will be included and randomized between Placebo Group&#xD;
      (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training). All&#xD;
      volunteers will be submitted to a control period of four weeks before the beginning of the&#xD;
      resistance training, which will have 12 weeks of duration. The assessments will be done at&#xD;
      baseline, after the control period and after the training period. The training sessions will&#xD;
      be performed twice a week and the training protocol will be performed with repetition maximum&#xD;
      periodization. The LLLT will be applied before the training sessions on eight points of the&#xD;
      quadriceps muscles, leading to a total of 240 Joules on each leg. The placebo LLLT will be&#xD;
      applied on the same way, but with the equipment turned off. The assessments will include&#xD;
      muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1&#xD;
      Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by&#xD;
      the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">December 22, 2017</completion_date>
  <primary_completion_date type="Actual">December 22, 2017</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Isokinetic peak torque of quadriceps muscle</measure>
    <time_frame>Change from baseline in isokinetic peak torque at 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Leg-extension 1RM test</measure>
    <time_frame>Change from baseline in leg-extension 1RM test at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg-press 1RM test</measure>
    <time_frame>Change from baseline in leg-press 1RM test at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle architecture</measure>
    <time_frame>Change from baseline in muscle architecture at 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Function</measure>
    <time_frame>Change from baseline in physical function at 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Elderly Men</condition>
  <arm_group>
    <arm_group_label>LLLT Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Low Level Laser Therapy application before resistance training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Low Level Laser Therapy</intervention_name>
    <description>Active application of Low Level Laser Therapy with a dose of 240 Joules</description>
    <arm_group_label>LLLT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>Resistance Training</description>
    <arm_group_label>LLLT Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo Low Level Laser Therapy</intervention_name>
    <description>Placebo application of Low Level Laser Therapy</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly men with age ranging from 60 to 80 years in condition to participate in the&#xD;
             strength training program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who already participate in strength training programs;&#xD;
&#xD;
          -  Individuals who participated in strength training programs less than three months&#xD;
             before the beginning of the study;&#xD;
&#xD;
          -  Individuals with any kind musculoskeletal injuries in the lower limbs that impair the&#xD;
             performance of the exercises;&#xD;
&#xD;
          -  Individuals with contraindications to the performance of high intensity exercises,&#xD;
             such as cardiovascular or neurological diseases;&#xD;
&#xD;
          -  Individuals with difficulties in understanding and/or performing the exercises;&#xD;
&#xD;
          -  Individuals who did not attend to at least 85% of the sessions or had 02 consecutive&#xD;
             absences and did not recover them.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidade Federal do Rio Grande do Sul</name>
      <address>
        <city>Pôrto Alegre</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Health Science of Porto Alegre</investigator_affiliation>
    <investigator_full_name>Bruno Manfredini Baroni</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03287284
org study id: 59328316.9.0000.5345
nct id: NCT03287284
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Phototherapy has been largely used in rehabilitation programs due to its analgesic,
      antiinflammatory and healing effects. Lately, its effects of optimizing the results of
      resistance training on young individuals have been studied. However, there is a lack of
      studies on its effect on the elderly population. The objective of the present study is to
      verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in
      the elderly. The study will be a randomized doubled-blinded controlled trial. 30 elderly men
      with age ranging from 60 to 80 years will be included and randomized between Placebo Group
      (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training). All
      volunteers will be submitted to a control period of four weeks before the beginning of the
      resistance training, which will have 12 weeks of duration. The assessments will be done at
      baseline, after the control period and after the training period. The training sessions will
      be performed twice a week and the training protocol will be performed with repetition maximum
      periodization. The LLLT will be applied before the training sessions on eight points of the
      quadriceps muscles, leading to a total of 240 Joules on each leg. The placebo LLLT will be
      applied on the same way, but with the equipment turned off. The assessments will include
      muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1
      Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by
      the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Isokinetic peak torque of quadriceps muscle
time frame: Change from baseline in isokinetic peak torque at 12 weeks
measure: Leg-extension 1RM test
time frame: Change from baseline in leg-extension 1RM test at 12 weeks
measure: Leg-press 1RM test
time frame: Change from baseline in leg-press 1RM test at 12 weeks
measure: Muscle architecture
time frame: Change from baseline in muscle architecture at 12 weeks
measure: Physical Function
time frame: Change from baseline in physical function at 12 weeks
arm group label: LLLT Group
arm group type: Active Comparator
description: Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo Low Level Laser Therapy application before resistance training
intervention type: Device
intervention name: Active Low Level Laser Therapy
description: Active application of Low Level Laser Therapy with a dose of 240 Joules
arm group label: LLLT Group
intervention type: Behavioral
intervention name: Resistance Training
description: Resistance Training
arm group label: LLLT Group
arm group label: Placebo Group
intervention type: Device
intervention name: Placebo Low Level Laser Therapy
description: Placebo application of Low Level Laser Therapy
arm group label: Placebo Group
criteria: 
gender: Male
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Health Science of Porto Alegre
investigator full name: Bruno Manfredini Baroni
investigator title: Phd