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.

Condition	Treatment or Intervention	Phase
Diabetes Mellitus Hypertension Hyperlipidemia	Behavior: exercise	Phase I Phase II

Further Study Details: 

Primary Outcomes: Systolic blood pressure; low-density lipoprotein cholesterol; hemoglobin A1c
Secondary Outcomes: 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)
Expected Total Enrollment:  561

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.

Ages Eligible for Study:  45 Years   -   89 Years,  Genders Eligible for Study:  Both

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

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

Study ID Numbers:  SHPCR-2003-1
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  March 21, 2005
ClinicalTrials.gov Identifier:  NCT00106236
Health Authority: Japan: Pharmaceutical and Medical Safety Bureau - Ministry of Health, Labor, and Welfare (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08