Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

July 13, 2009 updated by: Sapporo Health Promotion Foundation

Sapporo Fitness Club Trial (SFCT): A Randomized Controlled Trial to Test the Efficacy of Exercise at a Fitness Club for the Reduction of Cardiovascular Risk Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment

561

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0063
        • Sapporo Health Promotion Center

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

45 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Body mass index (BMI) of 24.2-34.9 with 2 or more of the following risk factors:

  • Resting systolic blood pressure of 130-179 mmHg
  • Fasting blood glucose of 110-139 mg/dl, or HbA1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl
  • LDL-cholesterol of 120-219 mg/dl

Exclusion Criteria:

  • Diastolic blood pressure of 110 mmHg or greater
  • History of clinical heart disease or stroke
  • Orthopedic problems that might interfere with exercise
  • Dementia
  • Abnormal exercise EKG test results
  • Private physician's disapproval

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
hemoglobin A1c
Systolic blood pressure
low-density lipoprotein cholesterol

Secondary Outcome Measures

Outcome Measure
Body weight
waist circumference
diastolic blood pressure
HDL-cholesterol
triglyceride
casual blood glucose
high-sensitivity C-reactive protein
white blood cell count
estimated VO2max
bicycle time
leg muscle strength
health-related QOL (Quality of Life)

Collaborators and Investigators

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

Sponsor

Sapporo Health Promotion Foundation

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

April 1, 2003

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

March 21, 2005

First Submitted That Met QC Criteria

March 21, 2005

First Posted (Estimate)

March 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 14, 2009

Last Update Submitted That Met QC Criteria

July 13, 2009

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHPCR-2003-1

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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