Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

Status Completed

Clinical Trial Summary

The purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.

Clinical Trial Description

Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. Past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. Does exercise differentially act on various risk factors in the same subject? Do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? To our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs.

Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month period. The second 6-month period is for follow-up and other purposes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00106236
Study type	Interventional
Source	Sapporo Health Promotion Foundation
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	April 2003
Completion date	April 2004

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