Clinical trial NCT00106236: Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Hypertension
Hyperlipidemia
Keywords: Exercise
Fitness Club
Randomized Controlled Trial
Cardiovascular Risk Factor
Overweight
Inactivity
Lead sponsor: Sapporo Health Promotion Foundation
Sponsor class: OTHER
First posted: 2005-03-22
Enrollment: 561
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure
measure: low-density lipoprotein cholesterol
measure: hemoglobin A1c
Secondary outcomes:
measure: Body weight
measure: waist circumference
measure: diastolic blood pressure
measure: HDL-cholesterol
measure: triglyceride
measure: casual blood glucose
measure: high-sensitivity C-reactive protein
measure: white blood cell count
measure: estimated VO2max
measure: bicycle time
measure: leg muscle strength
measure: health-related QOL (Quality of Life)
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Sapporo Health Promotion Center
state: Hokkaido
Study officials:
References:
citation: 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. doi: 10.1253/circj.68.1199.