Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106236
• Other study ID #: SHPCR-2003-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 21, 2005
• Last updated: July 13, 2009
• Start date: April 2003
• Est. completion date: April 2004

Study information

• Verified date: March 2005
• Source: Sapporo Health Promotion Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 89 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperlipidemia
• Hyperlipidemias
• Hypertension

Intervention

Behavioral:
• exercise

Locations

Country	Name	City	State
Japan	Sapporo Health Promotion Center	Sapporo	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Sapporo Health Promotion Foundation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Igarashi K, Fujita K, Yamase T, Morita N, Okita K, Satake K, Kanazawa N, Nishijima H. Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--. Circ J. 2004 Dec;68(12):1199-204. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure
Primary	low-density lipoprotein cholesterol
Primary	hemoglobin A1c
Secondary	Body weight
Secondary	waist circumference
Secondary	diastolic blood pressure
Secondary	HDL-cholesterol
Secondary	triglyceride
Secondary	casual blood glucose
Secondary	high-sensitivity C-reactive protein
Secondary	white blood cell count
Secondary	estimated VO2max
Secondary	bicycle time
Secondary	leg muscle strength
Secondary	health-related QOL (Quality of Life)