Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011193
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2001-02-13
Brief Title:
Dose-Response to Exercise in Women Aged 45-75 Years DREW
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
Dose-response to Exercise in Women Aged 45-75 Years DREW
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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-kcalkg group and 103 in the 12-kcalkg 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 US 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 kcalkgwk 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
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-kcalkg group and 103 in the 12-kcalkg 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 US 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 kcalkgwk 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL066262 | NIH | None | httpsreporternihgovquickSearchR01HL066262 |