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

Hypertension Clinical Trial

— DREW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00011193
• Other study ID #: PBRC 26043
• Secondary ID: R01HL066262
• Status: Completed
• Start date: January 2001
• Est. completion date: December 2006

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Overweight
• Overweight or Obese
• Postmenopausal

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.

Locations

Country	Name	City	State
United States	Oak Cliff-South Dallas	Dallas	Texas
United States	The Cooper Institute	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Jordan AN, Jurca GM, Locke CT, Church TS, Blair SN. Pedometer indices for weekly physical activity recommendations in postmenopausal women. Med Sci Sports Exerc. 2005 Sep;37(9):1627-32. — View Citation

Jurca R, Church TS, Morss GM, Jordan AN, Earnest CP. Eight weeks of moderate-intensity exercise training increases heart rate variability in sedentary postmenopausal women. Am Heart J. 2004 May;147(5):e21. — View Citation

Morss GM, Jordan AN, Skinner JS, Dunn AL, Church TS, Earnest CP, Kampert JB, Jurca R, Blair SN. Dose Response to Exercise in Women aged 45-75 yr (DREW): design and rationale. Med Sci Sports Exerc. 2004 Feb;36(2):336-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2max and resting systolic blood pressure		at 6 months
Secondary	Fasting blood lipids and lipoproteins (total, HDL-, and LDL-cholesterol, triglycerides		at 6 months
Secondary	High sensitive C-reactive protein		at 6 months
Secondary	Fasting glucose		at 6 months
Secondary	Anthropometry (body composition and regional fat distribution)		at 6 months
Secondary	Blood pressure response to exercise		at 6 months
Secondary	Heart rate variability		at 6 months
Secondary	Health-related quality of life and other psychosocial variables		at 6 months
Secondary	Cardiovascular disease risk determined by a multiple logistic risk function		at 6 months
Secondary	Tertiary Outcomes	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.	at 6 months