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Completed

NCT Number: NCT00011193

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

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Oak Cliff-South Dallas, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Exercise

Behavioral

Compared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women.

Primary outcomes

  1. VO2max and resting systolic blood pressure

    Time frame: at 6 months

Secondary outcomes

  1. Fasting blood lipids and lipoproteins (total, HDL-, and LDL-cholesterol, triglycerides

    Time frame: at 6 months

  2. High sensitive C-reactive protein

    Time frame: at 6 months

  3. Fasting glucose

    Time frame: at 6 months

  4. Anthropometry (body composition and regional fat distribution)

    Time frame: at 6 months

  5. Blood pressure response to exercise

    Time frame: at 6 months

  6. Heart rate variability

    Time frame: at 6 months

  7. Health-related quality of life and other psychosocial variables

    Time frame: at 6 months

  8. Cardiovascular disease risk determined by a multiple logistic risk function

    Time frame: at 6 months

  9. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: DREW

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Feb 13, 2001
Registry last updated
Sep 15, 2022

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

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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.

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