"We Walk": Impact of Exercise Dose on Health Outcomes Among Women Ages 60-75 (WW)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||We Walk - Energy Expenditure and Health Outcomes in Older, Sedentary Women.|
- 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) ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722136
|United States, South Carolina|
|Public Health Research Center University of South Carolina|
|Columbia, South Carolina, United States, 29201|
|Principal Investigator:||Xuewen Wang, PhD, MEd, BM||University of South Carolina|