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Dose-Response to Exercise in Women Aged 45-75 Years (DREW) (DREW)

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ClinicalTrials.gov Identifier: NCT00011193
Recruitment Status : Completed
First Posted : February 13, 2001
Last Update Posted : May 28, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Timothy Church, Pennington Biomedical Research Center

Tracking Information
First Submitted Date February 13, 2001
First Posted Date February 13, 2001
Last Update Posted Date May 28, 2012
Study Start Date January 2001
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2012)
VO2max and resting systolic blood pressure [ Time Frame: at 6 months ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2012)
  • Fasting blood lipids and lipoproteins (total, HDL-, and LDL-cholesterol, triglycerides [ Time Frame: at 6 months ]
  • High sensitive C-reactive protein [ Time Frame: at 6 months ]
  • Fasting glucose [ Time Frame: at 6 months ]
  • Anthropometry (body composition and regional fat distribution) [ Time Frame: at 6 months ]
  • Blood pressure response to exercise [ Time Frame: at 6 months ]
  • Heart rate variability [ Time Frame: at 6 months ]
  • Health-related quality of life and other psychosocial variables [ Time Frame: at 6 months ]
  • Cardiovascular disease risk determined by a multiple logistic risk function [ Time Frame: at 6 months ]
  • Tertiary Outcomes [ Time Frame: at 6 months ]
    Other variables of interest include dietary habits, physical activity history, smoking, alcohol intake, sleep habits, medication use (including HRT), demographic characteristics, unstructured physical activity, menstrual history, and personal and family medical history.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dose-Response to Exercise in Women Aged 45-75 Years (DREW)
Official Title Dose-response to Exercise in Women Aged 45-75 Years (DREW)
Brief Summary To investigate the effects of different amounts of exercise on both cardiorespiratory fitness and risk factors for cardiovascular disease in sedentary, overweight, mildly hypertensive, but healthy, postmenopausal women aged 45 to 75 years.
Detailed Description

BACKGROUND:

The primary goal of the Dose-Response to Exercise in Women aged 45-75 Years (DREW) was to investigate the effects of different amounts of exercise on both cardiorespiratory fitness and risk factors for cardiovascular disease. Participants were sedentary, overweight or obese, postmenopausal women who had high normal blood pressure or Stage I hypertension, and thus are at moderately high risk for cardiovascular disease. A total of 464 women (about 35% were recruited from minority groups) were randomly assigned to a control group (N = 102) or to 1 of 3 exercise groups (N = 155 for the lowest exercise dose and 104 in the 8-kcal/kg group and 103 in the 12-kcal/kg exercise group). Women assigned to the exercise groups exercised for 6 months at energy expenditures of 4, 8, or 12 kcal ·kg-1 · week-1. These exercise doses represent the consensus public health recommendation for physical activity from recently published guidelines from the U.S. Public Health Service, American Heart Association, and American College of Sports Medicine (8 kcal ·kg-1 · week-1) and at doses 50% below (4 kcal ·kg-1 · week-1) and 50% above (12 kcal ·kg-1 · week-1) the consensus dose. All women exercised at 50% of V02 max. The exercise sessions took place in the exercise laboratory, with individual supervision of each session and strict control of frequency, duration, and intensity. This was provided thorough documentation of the exact amount of exercise completed. Primary outcome measures are VO2 max and resting systolic blood pressure. Other cardiovascular disease risk factors, psychosocial variables, health-related quality of life, body composition, and fat distribution are secondary outcomes. Other secondary analyses included a focus on the extent to which observed dose-response effects are modified by baseline levels of fitness, ethnicity, risk factors, or age. Assessments will take place at baseline and 6 months. The research provided information about (1) patterns of change in outcomes produced by each of several exercise doses, (2) whether performing exercise at less than the current consensus dose has any benefit, (3) whether performing more exercise than the consensus dose has greater (or proportionally greater) health benefits, and (4) the characteristics of sedentary women who are most likely to benefit from various exercise doses.

DESIGN NARRATIVE:

A total of 464 sedentary, postmenopausal women at moderate risk for cardiovascular disease was randomly assigned to receive exercise training at one of three doses (4, 8, or 12 kcal/kg/wk) or no exercise for six months duration. The specific aims were be to determine: (a) if women in the exercise groups have increased aerobic power (VO2max) over the six months compared to the no exercise group; (b) if women in the exercise groups have a greater reduction in resting systolic blood pressure than those in the no exercise group; and, (c) if there will be a dose-response gradient across the three exercise groups for changes in aerobic power and systolic blood pressure. Secondary aims include evaluating the effects of exercise dose on fasting blood lipids and lipoproteins, glucose, insulin, anthropometry, self-reported quality of life, and cardiovascular risk as determined by a multiple logistic risk function. Covariates to be controlled included dietary intake, physical activity (outside of the exercise program), smoking, alcohol intake, sleep habits, medication use (including hormone replacement therapy), demographics, menstrual history, personal and family medical history.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Postmenopausal women aged 45 to 75 years who are overweight
Condition
  • Cardiovascular Diseases
  • Hypertension
  • Postmenopausal
  • Overweight or Obese
Intervention Behavioral: Exercise
Compared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women.
Study Groups/Cohorts
  • Non-Exercise Control Group
    We randomly assigned 102 women in the non-exercise control group and were asked to maintain their level of activity for the 6-month study period.
    Intervention: Behavioral: Exercise
  • 4-kcal/kg Energy Expenditure per week
    We randomly assigned 155 women to the 4-kcal/kg per week group for 6 months.
    Intervention: Behavioral: Exercise
  • 8-kcal/kg Energy Expenditure per week
    We randomly assigned 104 women to the 8-kcal/kg per week group for 6 months.
    Intervention: Behavioral: Exercise
  • 12-kcal/kg Energy Expenditure per week
    We randomly assigned 103 women to the 12-kcal/kg per week group for 6 months.
    Intervention: Behavioral: Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 25, 2012)
464
Original Enrollment Not Provided
Actual Study Completion Date December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria Postmenopausal women aged 45 to 75 years who are overweight or obese (body mass index of 25 to 40 kg/m2) and have normal or mildly elevated BP.
Sex/Gender
Sexes Eligible for Study: Female
Ages 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00011193
Other Study ID Numbers HL66262
R01HL066262 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Timothy Church, Pennington Biomedical Research Center
Study Sponsor Pennington Biomedical Research Center
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Steven N. Blair, PED University of South Carolina
Principal Investigator: Timothy S. Church, MD, PhD, MPH Pennnington Biomedical Research Center
Study Director: Conrad P. Earnest, PhD University of Bath
Study Director: James S. Skinner, hD Indiana University
PRS Account Pennington Biomedical Research Center
Verification Date May 2012