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Physical Activity and Cardiovascular Disease Prevention

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005447
    Brief Title
    Physical Activity and Cardiovascular Disease Prevention
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To provide new scientific information regarding the role of physical activity in primary and secondary disease prevention, particularly coronary heart disease (CHD).
    Detailed Description
    DESIGN NARRATIVE: The long-term follow-up and data analysis of two epidemiologic studies, a general population study and a clinical trial provided the basis for the study. The first study assessed the long-term relationship between total physical activity (both during work and leisure time) and mortality in a random sample of 1,656 Black and white men and women residents of the City of Buffalo, New York. The study focused on participants (30+ years of age at baseline) of the Buffalo Health Study, an epidemiological investigation conducted in Buffalo in 1960. As part of the investigation, detailed information was gathered from participants with regard to a number of demographic and socioeconomic characteristics (age, body mass index, education, marital status, etc.) and the participants' usual daily activities (both during a weekday and weekend) at work and outside work. This information was used to compute a total physical activity index. The study related the participants' physical activity characteristics to their all-cause and CHD mortality experience throughout the follow-up period and tested whether or not the relationship between physical activity and mortality was similar across gender and race. The detailed baseline demographic and socioeconomic data allowed analysis of the independence of any observed association between physical activity and mortality. The second study extended to 17 years, the follow-up of the National Exercise and Heart Disease Project (NEHDP), a multi-center, randomized clinical trial designed to study the effects of a regular, medically prescribed and supervised exercise program on the rehabilitation of male survivors (ages 30-64 at baseline) of a myocardial infarction (MI). Three year findings from the trial reported non-significant differences between the treatment and control groups for all-cause mortality, and recurrent MI in favor of the exercise group. Other outcomes favoring the treatment group were reported after one year and included increased physical working capacity, and decreased body fat, diastolic blood pressure, and triglycerides. The study determined vital status for all original study participants, and cause of death in the deceased. The longer follow-up permitted analysis of whether the long-term survival of the treatment group differed from that of the controls. In addition, the investigators were able to assess if the risk factor changes observed in the first year of the trial were present after three years, whether these changes were related to long-term survival, whether differences in mortality observed in sub-groups (i.e. smokers) after three years remained after 17 years, and whether baseline patient characteristics (i.e., anxiety and depression) predicted mortality. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10475536
    Citation
    Dorn JP, Cerny FJ, Epstein LH, Naughton J, Vena JE, Winkelstein W Jr, Schisterman E, Trevisan M. Work and leisure time physical activity and mortality in men and women from a general population sample. Ann Epidemiol. 1999 Aug;9(6):366-73. doi: 10.1016/s1047-2797(99)00025-3.
    Results Reference
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    Physical Activity and Cardiovascular Disease Prevention

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