Cardiovascular DiseasesDREWNCT00011193
Dose-Response to Exercise in Women Aged 45-75 Years (DREW)
An observational study of Cardiovascular Diseases and Hypertension, run by Pennington Biomedical Research Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Postmenopausal
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 464 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2001to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women aged 45 to 75 years who are overweight
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oak Cliff-South Dallas
Dallas, Texas, 75201
The Cooper Institute
Dallas, Texas, 75230
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise
- Keywords
- Cardiovascular Diseases, Hypertension, Postmenopausal, Overweight or Obese, Women, Sedentary
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Overweight, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Compared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max and resting systolic blood pressure
Measured: at 6 months
Secondary outcomes (9)
Fasting blood lipids and lipoproteins (total, HDL-, and LDL-cholesterol, triglycerides
Measured: at 6 months
High sensitive C-reactive protein
Measured: at 6 months
Fasting glucose
Measured: at 6 months
Anthropometry (body composition and regional fat distribution)
Measured: at 6 months
Blood pressure response to exercise
Measured: at 6 months
Heart rate variability
Measured: at 6 months
Health-related quality of life and other psychosocial variables
Measured: at 6 months
Cardiovascular disease risk determined by a multiple logistic risk function
Measured: at 6 months
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.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2001 (estimated)
- Study startJan 2001
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Steven N. Blair, PED, Principal investigator, University of South CarolinaTimothy S. Church, MD, PhD, MPH, Principal investigator, Pennnington Biomedical Research CenterConrad P. Earnest, PhD, Study director, University of BathJames S. Skinner, hD, Study director, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011193
- Sponsor's protocol ID
- PBRC 26043
- Other IDs
- R01HL066262
- Acronym
- DREW
- Status last verified
- Sep 2022
- First submitted
- 13 Feb 2001
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1249/01.MSS.0000113738.06267.E5.
PubMed 14767260Jurca 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. doi: 10.1016/j.ahj.2003.10.024.
PubMed 15131556Jordan 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. doi: 10.1249/01.mss.0000177455.58960.aa.
PubMed 16177618Kline CE, Sui X, Hall MH, Youngstedt SD, Blair SN, Earnest CP, Church TS. Dose-response effects of exercise training on the subjective sleep quality of postmenopausal women: exploratory analyses of a randomised controlled trial. BMJ Open. 2012 Jul 12;2(4):e001044. doi: 10.1136/bmjopen-2012-001044. Print 2012.
PubMed 22798253Johannsen NM, Swift DL, Johnson WD, Dixit VD, Earnest CP, Blair SN, Church TS. Effect of different doses of aerobic exercise on total white blood cell (WBC) and WBC subfraction number in postmenopausal women: results from DREW. PLoS One. 2012;7(2):e31319. doi: 10.1371/journal.pone.0031319. Epub 2012 Feb 17.
PubMed 22363616Stewart LK, Earnest CP, Blair SN, Church TS. Effects of different doses of physical activity on C-reactive protein among women. Med Sci Sports Exerc. 2010 Apr;42(4):701-7. doi: 10.1249/MSS.0b013e3181c03a2b.
PubMed 19952829Church TS, Martin CK, Thompson AM, Earnest CP, Mikus CR, Blair SN. Changes in weight, waist circumference and compensatory responses with different doses of exercise among sedentary, overweight postmenopausal women. PLoS One. 2009;4(2):e4515. doi: 10.1371/journal.pone.0004515. Epub 2009 Feb 18.
PubMed 19223984Martin CK, Church TS, Thompson AM, Earnest CP, Blair SN. Exercise dose and quality of life: a randomized controlled trial. Arch Intern Med. 2009 Feb 9;169(3):269-78. doi: 10.1001/archinternmed.2008.545.
PubMed 19204218Earnest CP, Lavie CJ, Blair SN, Church TS. Heart rate variability characteristics in sedentary postmenopausal women following six months of exercise training: the DREW study. PLoS One. 2008 Jun 4;3(6):e2288. doi: 10.1371/journal.pone.0002288.
PubMed 18523583Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007 May 16;297(19):2081-91. doi: 10.1001/jama.297.19.2081.
PubMed 17507344
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response to Exercise in Women Aged 45-75 Years (DREW)
- ClinicalTrials.gov ID
- NCT00011193
- Acronym / sponsor ID
- DREW / PBRC 26043
- Keywords
- Cardiovascular Diseases, Hypertension, Postmenopausal, Overweight or Obese, Women, Sedentary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Exercise Control Group | – | Behavioral: ExerciseWe 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. |
| 4-kcal/kg Energy Expenditure per week | – | Behavioral: ExerciseWe randomly assigned 155 women to the 4-kcal/kg per week group for 6 months. |
| 8-kcal/kg Energy Expenditure per week | – | Behavioral: ExerciseWe randomly assigned 104 women to the 8-kcal/kg per week group for 6 months. |
| 12-kcal/kg Energy Expenditure per week | – | Behavioral: ExerciseWe randomly assigned 103 women to the 12-kcal/kg per week group for 6 months. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women aged 45 to 75 years who are overweight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseCompared the effect of 50%, 100%, and 150% of the NIH Consensus Development Panel recommended physical activity dose on fitness in women. | Behavioural | 12-kcal/kg Energy Expenditure per week, 4-kcal/kg Energy Expenditure per week, 8-kcal/kg Energy Expenditure per week, Non-Exercise Control Group |
Primary outcome
VO2max and resting systolic blood pressure
Time frame: at 6 months
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Background: PubMed 14767260Morss 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. doi: 10.1249/01.MSS.0000113738.06267.E5.
- Background: PubMed 15131556Jurca 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. doi: 10.1016/j.ahj.2003.10.024.
- Background: PubMed 16177618Jordan 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. doi: 10.1249/01.mss.0000177455.58960.aa.
- Derived from this study: PubMed 22798253Kline CE, Sui X, Hall MH, Youngstedt SD, Blair SN, Earnest CP, Church TS. Dose-response effects of exercise training on the subjective sleep quality of postmenopausal women: exploratory analyses of a randomised controlled trial. BMJ Open. 2012 Jul 12;2(4):e001044. doi: 10.1136/bmjopen-2012-001044. Print 2012.
- Derived from this study: PubMed 22363616Johannsen NM, Swift DL, Johnson WD, Dixit VD, Earnest CP, Blair SN, Church TS. Effect of different doses of aerobic exercise on total white blood cell (WBC) and WBC subfraction number in postmenopausal women: results from DREW. PLoS One. 2012;7(2):e31319. doi: 10.1371/journal.pone.0031319. Epub 2012 Feb 17.
- Derived from this study: PubMed 19952829Stewart LK, Earnest CP, Blair SN, Church TS. Effects of different doses of physical activity on C-reactive protein among women. Med Sci Sports Exerc. 2010 Apr;42(4):701-7. doi: 10.1249/MSS.0b013e3181c03a2b.
- Derived from this study: PubMed 19223984Church TS, Martin CK, Thompson AM, Earnest CP, Mikus CR, Blair SN. Changes in weight, waist circumference and compensatory responses with different doses of exercise among sedentary, overweight postmenopausal women. PLoS One. 2009;4(2):e4515. doi: 10.1371/journal.pone.0004515. Epub 2009 Feb 18.
- Derived from this study: PubMed 19204218Martin CK, Church TS, Thompson AM, Earnest CP, Blair SN. Exercise dose and quality of life: a randomized controlled trial. Arch Intern Med. 2009 Feb 9;169(3):269-78. doi: 10.1001/archinternmed.2008.545.
- Derived from this study: PubMed 18523583Earnest CP, Lavie CJ, Blair SN, Church TS. Heart rate variability characteristics in sedentary postmenopausal women following six months of exercise training: the DREW study. PLoS One. 2008 Jun 4;3(6):e2288. doi: 10.1371/journal.pone.0002288.
- Derived from this study: PubMed 17507344Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007 May 16;297(19):2081-91. doi: 10.1001/jama.297.19.2081.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven N. Blair, PED principal investigator
University of South Carolina
Timothy S. Church, MD, PhD, MPH principal investigator
Pennnington Biomedical Research Center
Conrad P. Earnest, PhD study director
University of Bath
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by Pennington Biomedical Research Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2max and resting systolic blood pressure (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00011193, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.