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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of South Carolina
Sponsor:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01722136
First received: October 24, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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. 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.


Condition Intervention
Exercise Impact on Sedentary, Elderly Women
Behavioral: Low Dosage
Behavioral: High Dosage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 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

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01722136

Contacts
Contact: Ellen Wingard 803-777-4580 ewingard@mailbox.sc.edu
Contact: Kim Bowyer 803-777-8291 chapmakp@mailbox.sc.edu

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

Additional Information:
No publications provided

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01722136     History of Changes
Other Study ID Numbers: 11530-FA79
Study First Received: October 24, 2012
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014