NCT00011193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

February 13, 2001

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

5.9 years

First QC Date

February 13, 2001

Last Update Submit

September 13, 2022

Conditions

Cardiovascular DiseasesHypertensionPostmenopausalOverweight or Obese

Keywords

Cardiovascular DiseasesHypertensionPostmenopausalOverweight or ObeseWomenSedentary

Outcome Measures

Primary Outcomes (1)

  • VO2max and resting systolic blood pressure

    at 6 months

Secondary Outcomes (9)

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

    at 6 months

  • High sensitive C-reactive protein

    at 6 months

  • Fasting glucose

    at 6 months

  • Anthropometry (body composition and regional fat distribution)

    at 6 months

  • Blood pressure response to exercise

    at 6 months

  • +4 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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

12-kcal/kg Energy Expenditure per week4-kcal/kg Energy Expenditure per week8-kcal/kg Energy Expenditure per weekNon-Exercise Control Group

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Oak Cliff-South Dallas

Dallas, Texas, 75201, United States

Location

The Cooper Institute

Dallas, Texas, 75230, United States

Location

Related Publications (10)

  • 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.

    PMID: 14767260BACKGROUND

  • 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. doi: 10.1016/j.ahj.2003.10.024.

    PMID: 15131556BACKGROUND

  • 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. doi: 10.1249/01.mss.0000177455.58960.aa.

    PMID: 16177618BACKGROUND

  • Kline 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.

    PMID: 22798253DERIVED

  • Johannsen 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.

    PMID: 22363616DERIVED

  • Stewart 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.

    PMID: 19952829DERIVED

  • Church 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.

    PMID: 19223984DERIVED

  • Martin 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.

    PMID: 19204218DERIVED

  • Earnest 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.

    PMID: 18523583DERIVED

  • Church 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.

    PMID: 17507344DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionOverweightObesitySedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven N. Blair, PED

    University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Timothy S. Church, MD, PhD, MPH

    Pennnington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • Conrad P. Earnest, PhD

    University of Bath

    STUDY DIRECTOR

  • James S. Skinner, hD

    Indiana University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2001

First Posted

February 13, 2001

Study Start

January 1, 2001

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

US(2)