Skip to main content
OpenTrials
Completed

NCT Number: NCT01722136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Research Center University of South Carolina

Columbia, South Carolina, 29201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Dosage

Behavioral

Exercise dose of 8kcal/kg/week

High Dosage

Behavioral

Exercise dose of 14kcal/kg/week

Primary outcomes

  1. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.

Acronym: WW

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2012
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.