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"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75 (WW)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01722136
First Posted: November 6, 2012
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Carolina
  Purpose
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.

Condition Intervention
Condition Behavioral: Low Dosage Behavioral: High Dosage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 72
Study Start Date: August 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dosage
Exercise dose of 8kcal/kg/week
Behavioral: Low Dosage
Exercise dose of 8kcal/kg/week
Experimental: High Dosage
Exercise dose 14kcal/kg/week
Behavioral: High Dosage
Exercise dose of 14kcal/kg/week

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18-30
  • Sedentary (exercising less than 20 minutes no more than 3 times per week)
  • Non-smoking
  • Weight stable (+/- 5%) over past 3 months

Exclusion Criteria:

  • Self-reported cardiovascular disease
  • Additional self-reported medical conditions
  • Medications known to affect metabolism
  • Excess caffeine use
  • Self-reported contradictions according to ACSM
  • Unwillingness to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722136


Locations
United States, South Carolina
Public Health Research Center University of South Carolina
Columbia, South Carolina, United States, 29201
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Xuewen Wang, PhD, MEd, BM University of South Carolina
  More Information

Additional Information:
Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01722136     History of Changes
Other Study ID Numbers: 11530-FA79
First Submitted: October 24, 2012
First Posted: November 6, 2012
Last Update Posted: May 12, 2016
Last Verified: May 2016