<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/NCT01707017</url>
  </required_header>
  <id_info>
    <org_study_id>S53709</org_study_id>
    <nct_id>NCT01707017</nct_id>
  </id_info>
  <brief_title>The Effects of Low- and High-intensity Resistance Exercise on Force-velocity Characteristics in Older Adults</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the impact of high- and low-intensity resistance&#xD;
      exercise on force-velocity characteristics, muscle mass and inflammatory processes in older&#xD;
      adults. As all training protocols are designed to end with maximal effort, effects are&#xD;
      expected to be similar between groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <primary_completion_date type="Actual">December 2012</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in force-velocity characteristics of knee extensors</measure>
    <time_frame>Baseline, 12weeks, 6 months</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Change in muscle volume</measure>
    <time_frame>Baseline, 12weeks, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in maximal strength (one repetition maximum)</measure>
    <time_frame>Baseline, 4weeks, 8weeks, 12weeks, 6 months</time_frame>
    <description>Strength is measured as the maximum weight on the training equipment that can be lifted only one time (= one repetition maximum).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in motivation</measure>
    <time_frame>Baseline, every week for 12 weeks, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>Baseline, 12weeks, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in inflammatory markers in blood</measure>
    <time_frame>Baseline, 12weeks, 6 months</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Effects of Strength Training in Older Adults</condition>
  <arm_group>
    <arm_group_label>High-load strength training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-load strength training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-load + moderate-load strength training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <arm_group_label>High-load strength training</arm_group_label>
    <arm_group_label>Low-load + moderate-load strength training</arm_group_label>
    <arm_group_label>Low-load strength training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 60 to 80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Knee or hip prothesis&#xD;
&#xD;
          -  Systematic training&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Acute lower back pain&#xD;
&#xD;
          -  Dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Kinesiology and Rehabilitation Sciences</name>
      <address>
        <city>Leuven</city>
        <zip>3001</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2011</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>February 19, 2013</last_update_submitted>
  <last_update_submitted_qc>February 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01707017
org study id: S53709
nct id: NCT01707017
lead sponsor: 
The purpose of this study is to compare the impact of high- and low-intensity resistance
      exercise on force-velocity characteristics, muscle mass and inflammatory processes in older
      adults. As all training protocols are designed to end with maximal effort, effects are
      expected to be similar between groups.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: Change in force-velocity characteristics of knee extensors
time frame: Baseline, 12weeks, 6 months
measure: Change in muscle volume
time frame: Baseline, 12weeks, 6 months
measure: Change in maximal strength (one repetition maximum)
time frame: Baseline, 4weeks, 8weeks, 12weeks, 6 months
description: Strength is measured as the maximum weight on the training equipment that can be lifted only one time (= one repetition maximum).
measure: Change in motivation
time frame: Baseline, every week for 12 weeks, 6 months
measure: Change in physical activity
time frame: Baseline, 12weeks, 6 months
measure: Change in inflammatory markers in blood
time frame: Baseline, 12weeks, 6 months
arm group label: High-load strength training
arm group type: Active Comparator
arm group label: Low-load strength training
arm group type: Active Comparator
arm group label: Low-load + moderate-load strength training
arm group type: Active Comparator
intervention type: Other
intervention name: Strength training
arm group label: High-load strength training
arm group label: Low-load + moderate-load strength training
arm group label: Low-load strength training
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Sponsor