Dose Response to Exercise and Cardiovascular Health

January 7, 2016 updated by: University of Florida
To determine the minimal dose of physical activity necessary to improve cardiovascular (CV) health by evaluating and aerobically training 500 healthy men and women, 30-65 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Results from the study will provide important data regarding the dose of exercise required to improve cardiovascular health, as described both by the NIH Consensus Conference on Physical Activity and CV Health and by the recent Report of the Surgeon General. The study was initiated in response to a Program Announcement released in October 1994 on Physical Activity and Cardiopulmonary Health.

DESIGN NARRATIVE:

Subjects were randomized into one of five groups in a 2x2 factorial design plus a usual care control group (n=100 in each of 5 groups). Subjects trained at a moderate (45-55 percent) or high (65-75 percent of maximum heart rate reserve) intensity, and at a frequency of 3-4 or 5-7 days/week (viz., Group 1, 65-75 percent at 5-7 days/week; Group 2, 65-75 percent at 3-4 days/week; Group 3, 45-55 percent at 5-7 days/weekk; Group 4, 45-55 percent at 3-4 days/week; and, Group 5, usual care control). Controls received advice from a physician to increase their physical activity. The subjects in Groups 1-4 participated in an exercise intervention using walking as the mode of training for a total of 24 months. A lifestyle model of physical activity was used, in that subjects could accumulate exercise minutes during the day in 10-minute increments or more continuously (for a total duration of 30 minutes/day), and training was conducted where it was most convenient for the subject (i.e. at home, work or some combination thereof). Tests occurred at baseline (0), 12, and 24 months of the intervention.

The hypothesis was that Groups 1-4 would show a significant reduction in systolic and diastolic blood pressure and an increase in HDL-cholesterol compared to the usual care control group. A second hypothesis was that that there would be significant main effects for both frequency and intensity, with the higher levels of each producing greater improvement on the major outcome variables compared to the lower levels of each dose. The study also planned to determine the minimal dose response to exercise necessary to elicit significant improvement in cardiovascular and behavioral health factors. Finally, the project included examination of the effects of age and level of initial test values on outcome variables to determine if their interactions affected the results of the intervention.

The study also includes assessment of the effect of specific doses of exercise on the reduction in systolic and diastolic blood pressure and increase in HDL-cholesterol (primary outcomes), in addition to changes in levels of physical activity, aerobic fitness (VO2 max), body composition (percent fat and waist-to-hip ratio), triglycerides, and LDL-cholesterol (secondary outcomes). Psychological variables (depression, anxiety, anger, and perceived stress) and health-related quality of life are also evaluated, and the important issue of adherence to exercise is examined with respect to the effect of dose of exercise.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Michael Perri, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5099
  • R01HL058873 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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