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Optimal Exercise Regimens for Persons at Increased Risk

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
exercise
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000523
    Brief Title
    Optimal Exercise Regimens for Persons at Increased Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1986 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. Also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.
    Detailed Description
    BACKGROUND: Regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed. This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting. DESIGN NARRATIVE: Following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. The intervention program was conducted for one year followed by a one-year maintenance program. Main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. Variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

    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 Ischemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1880885
    Citation
    King AC, Haskell WL, Taylor CB, Kraemer HC, DeBusk RF. Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial. JAMA. 1991 Sep 18;266(11):1535-42.
    Results Reference
    background

    Learn more about this trial

    Optimal Exercise Regimens for Persons at Increased Risk

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