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

Condition Clinical Trial

— WW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722136
• Other study ID #: Pro00016306
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: May 2016
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Condition

Intervention

Behavioral:
• Low Dosage
Exercise dose of 8kcal/kg/week
• High Dosage
Exercise dose of 14kcal/kg/week

Locations

Country	Name	City	State
United States	Public Health Research Center University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline total daily energy expenditure and its components (resting metabolic rate, thermic effect of food, non-exercise activity thermogenesis)in 4 months		Baseline (pre-intervention); 4 months (post-intervention)
Secondary	Change from baseline plasma leptin and serum free triiodo-L-thyronine (free T3) concentrations in 4 months		Baseline (pre-intervention); 4 month (post-intervention)

External Links

•   Brief description of study for potential participants