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Prospective Study of Health in Runners and Walkers
This study has been completed.
First Received: May 25, 2000   Last Updated: July 21, 2005   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005494
  Purpose

To compare rates of coronary heart disease (CHD), cancer, total mortality and exercise injuries in 68,000 runners and 68,000 walkers during four years of surveillance


Condition
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Coronary Heart Disease Risk Reduction
Breast Neoplasms
Neoplasms

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Coronary Artery Disease Heart Diseases
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1998
Estimated Study Completion Date: May 2004
Detailed Description:

BACKGROUND:

Current government physical fitness guidelines state that: 1) the majority of the health benefits from physical activity can be obtained by walking two miles briskly on most days of the week; and 2) the health benefits of physical activity depend principally on the total amount of activity rather than the intensity of the activity. Nevertheless, there are currently no prospective epidemiological studies extant, designed specifically to directly contrast the health benefits and costs of moderate exercise (e.g., walking) versus vigorous exercise (e.g., running).

DESIGN NARRATIVE:

Before the start of the study, 233,000 person-years of follow-up had been accumulated in 56,000 runners (between 1991 and 1997). The runners were resurveyed in 1997 along with 68,000 walkers. The walkers were also solicited through the publication of the questionnaire in Walking magazine followed by a direct mailing of the questionnaire to 425,000 subscribers. Total and cause-specific mortality will be determined from the National Death Index; fatal and nonfatal cancers will be identified from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) and 46 state registries; nonfatal coronary heart disease and injuries will be determined from questionnaires. Survival analyses will be used to test whether runners have greater reduction in heart disease, total mortality, and cancer per unit of exercise. Exercise-related injuries from walking and running will also be examined. Power calculations suggest that detection of differences between runners and walkers, as small as 11% for total mortality, 16% for CHD, 12% for total cancers, and 36% for breast cancer, will be possible. The differences will be adjusted for weekly kilocalories expended by walking and running, for walking and running distance, and for time spent on each activity to test whether these variables account for differences in disease rates between walkers and runners.

By the end of the study, 517,000 person years in 68,000 runners (between 1991 and 2001) will be available for analysis. Survival analysis will be used to test for a dose-response relationship between running mileage and CHD and cancer risk, and whether this relationship is affected by running intensity, running frequency, running history, gender, adiposity, age or medication use. Using conservative rates (25% below published values), statistical power calculations suggest that detectable reduction in coronary heart disease risk as small as 0.71% per mile will be possible, which is far below the estimated reduction from other published studies (2.1%). Additionally, a detectable reduction in breast cancer risk as small as 1.5% per mile run in women is calculated, which is below the 1.7% reduction in risk estimated from other published data.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005494

Sponsors and Collaborators
Investigators
Investigator: Paul Williams University of California Lawrence Berkeley Lab
  More Information

Publications:
Study ID Numbers: 5011
Study First Received: May 25, 2000
Last Updated: July 21, 2005
ClinicalTrials.gov Identifier: NCT00005494     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Skin Diseases
Myocardial Ischemia
Vascular Diseases
Breast Neoplasms
Arteriosclerosis
Ischemia
Breast Diseases
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Diseases
Skin Diseases
Myocardial Ischemia
Vascular Diseases
Breast Neoplasms
Arteriosclerosis
Coronary Disease
Neoplasms
Neoplasms by Site
Cardiovascular Diseases
Coronary Artery Disease
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009