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History of Changes for Study: NCT00005494
Prospective Study of Health in Runners and Walkers
Latest version (submitted February 26, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 July 21, 2005 Study Status and References
3 February 17, 2016 Eligibility, Study Status, Study Design, Study Description and Study Identification
4 February 26, 2016 Study Status and Study Identification
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Study NCT00005494
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 5011
Brief Title: Prospective Study of Health in Runners and Walkers
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2004
Overall Status: Completed
Study Start: June 1998
Primary Completion:
Study Completion: May 2004
First Submitted: May 25, 2000
First Submitted that
Met QC Criteria:
May 25, 2000
First Posted: May 26, 2000 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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
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.

Open or close this module Conditions
Conditions: Coronary Disease
Cardiovascular Diseases
Heart Diseases
Coronary Heart Disease Risk Reduction
Breast Neoplasms
Neoplasms
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Natural History
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment:
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 0 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria: No eligibility criteria
Open or close this module Contacts/Locations
Study Officials: Paul Williams
University of California Lawrence Berkeley Lab
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Williams PT. Physical fitness and activity as separate heart disease risk factors: a meta-analysis. Med Sci Sports Exerc. 2001 May;33(5):754-61. doi: 10.1097/00005768-200105000-00012. PubMed 11323544
Williams PT. Health effects resulting from exercise versus those from body fat loss. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S611-21; discussion S640-1. doi: 10.1097/00005768-200106001-00030. PubMed 11427786
Williams PT, Superko HR, Haskell WL, Alderman EL, Blanche PJ, Holl LG, Krauss RM. Smallest LDL particles are most strongly related to coronary disease progression in men. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):314-21. doi: 10.1161/01.atv.0000053385.64132.2d. PubMed 12588777
Williams PT. The illusion of improved physical fitness and reduced mortality. Med Sci Sports Exerc. 2003 May;35(5):736-40. doi: 10.1249/01.MSS.0000064995.89335.40. PubMed 12750581
Links:
Available IPD/Information:

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