<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/NCT01722136</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00016306</org_study_id>
    <nct_id>NCT01722136</nct_id>
  </id_info>
  <brief_title>&quot;We Walk&quot;: Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75</brief_title>
  <acronym>WW</acronym>
  <official_title>We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal is to determine whether any energy expenditure compensation in response to&#xD;
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose&#xD;
      intervention in older women, and to begin to investigate underlying physiological mechanisms&#xD;
      that influence energy expenditure changes in older women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal is to determine whether any energy expenditure compensation in response to&#xD;
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose&#xD;
      intervention in older women, and to begin to investigate underlying physiological mechanisms&#xD;
      that influence energy expenditure changes in older women. Changes in all components of energy&#xD;
      expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the&#xD;
      two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4&#xD;
      days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).&#xD;
&#xD;
      Specific Aim 1: To determine whether differential changes in total daily energy expenditure&#xD;
      and its components occur in older women in response to two exercise programs of different&#xD;
      doses. State-of-the-art methods will be used (total daily energy expenditure by doubly&#xD;
      labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System;&#xD;
      resting metabolic rate and thermic effect of food via indirect calorimetry).&#xD;
&#xD;
      Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase&#xD;
      in total daily energy expenditure in response to the higher-dose, compared to the lower-dose,&#xD;
      exercise program, despite greater increases in resting metabolic rate and thermic effect of&#xD;
      food.&#xD;
&#xD;
      Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free&#xD;
      triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic&#xD;
      exercise programs of two different doses.&#xD;
&#xD;
      We hypothesize that in response to the higher-dose exercise program, women will exhibit&#xD;
      larger decreases in plasma leptin and serum free T3 concentrations, compared to the&#xD;
      lower-dose exercise program.&#xD;
&#xD;
      We will also determine whether women exhibit greater improvements in plasma lipids, insulin&#xD;
      sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic&#xD;
      fitness in response to the higher-dose, compared to the lower-dose, exercise program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months</measure>
    <time_frame>Baseline (pre-intervention); 4 months (post-intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months</measure>
    <time_frame>Baseline (pre-intervention); 4 month (post-intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Condition</condition>
  <arm_group>
    <arm_group_label>Low Dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise dose of 8kcal/kg/week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise dose 14kcal/kg/week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Dosage</intervention_name>
    <description>Exercise dose of 8kcal/kg/week</description>
    <arm_group_label>Low Dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>High Dosage</intervention_name>
    <description>Exercise dose of 14kcal/kg/week</description>
    <arm_group_label>High Dosage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 18-30&#xD;
&#xD;
          -  Sedentary (exercising less than 20 minutes no more than 3 times per week)&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  Weight stable (+/- 5%) over past 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported cardiovascular disease&#xD;
&#xD;
          -  Additional self-reported medical conditions&#xD;
&#xD;
          -  Medications known to affect metabolism&#xD;
&#xD;
          -  Excess caffeine use&#xD;
&#xD;
          -  Self-reported contradictions according to ACSM&#xD;
&#xD;
          -  Unwillingness to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xuewen Wang, PhD, MEd, BM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Public Health Research Center University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://wewalk.sc.edu</url>
    <description>Brief description of study for potential participants</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of South Carolina</investigator_affiliation>
    <investigator_full_name>Xuewen Wang</investigator_full_name>
    <investigator_title>Assistant Professor</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/NCT01722136
org study id: Pro00016306
nct id: NCT01722136
lead sponsor: 
has dmc: No
The overall goal is to determine whether any energy expenditure compensation in response to
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose
      intervention in older women, and to begin to investigate underlying physiological mechanisms
      that influence energy expenditure changes in older women.
The overall goal is to determine whether any energy expenditure compensation in response to
      16 weeks of aerobic exercise at a higher-dose is greater compared to a lower-dose
      intervention in older women, and to begin to investigate underlying physiological mechanisms
      that influence energy expenditure changes in older women. Changes in all components of energy
      expenditure, as well as concentrations of plasma leptin and serum free T3, in response to the
      two different exercise programs (14 and 8 kcal/kg body weight weekly, 60-65% VO2max, 4
      days/wk) will be compared in older, non-obese women (60-75 yrs, BMI=18-30 kg/m2).

      Specific Aim 1: To determine whether differential changes in total daily energy expenditure
      and its components occur in older women in response to two exercise programs of different
      doses. State-of-the-art methods will be used (total daily energy expenditure by doubly
      labeled water; non-exercise activity thermogenesis using Physical Activity Monitoring System;
      resting metabolic rate and thermic effect of food via indirect calorimetry).

      Primary Hypothesis: Due to a greater decline in NEAT, women will exhibit a smaller increase
      in total daily energy expenditure in response to the higher-dose, compared to the lower-dose,
      exercise program, despite greater increases in resting metabolic rate and thermic effect of
      food.

      Specific Aim 2: To explore whether differential changes occur in plasma leptin and serum free
      triiodo-L-thyronine (free T3) concentrations in older women in response to 16-week aerobic
      exercise programs of two different doses.

      We hypothesize that in response to the higher-dose exercise program, women will exhibit
      larger decreases in plasma leptin and serum free T3 concentrations, compared to the
      lower-dose exercise program.

      We will also determine whether women exhibit greater improvements in plasma lipids, insulin
      sensitivity (using homeostasis model assessment, HOMA, score), blood pressure, and aerobic
      fitness in response to the higher-dose, compared to the lower-dose, exercise program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months
time frame: Baseline (pre-intervention); 4 months (post-intervention)
measure: Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months
time frame: Baseline (pre-intervention); 4 month (post-intervention)
arm group label: Low Dosage
arm group type: Experimental
description: Exercise dose of 8kcal/kg/week
arm group label: High Dosage
arm group type: Experimental
description: Exercise dose 14kcal/kg/week
intervention type: Behavioral
intervention name: Low Dosage
description: Exercise dose of 8kcal/kg/week
arm group label: Low Dosage
intervention type: Behavioral
intervention name: High Dosage
description: Exercise dose of 14kcal/kg/week
arm group label: High Dosage
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xuewen Wang, PhD, MEd, BM
role: Principal Investigator
affiliation: University of South Carolina
facility: 
country: United States
url: http://wewalk.sc.edu
description: Brief description of study for potential participants
responsible party type: Principal Investigator
investigator affiliation: University of South Carolina
investigator full name: Xuewen Wang
investigator title: Assistant Professor