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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 561
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diastolic blood pressure of 110 mmHg or greater
- •History of clinical heart disease or stroke
- •Orthopedic problems that might interfere with exercise
- •Abnormal exercise EKG test results
- •Private physician's disapproval
结局指标
主要结局
Systolic blood pressure
low-density lipoprotein cholesterol
hemoglobin A1c
次要结局
- 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)
- diastolic blood pressure
- HDL-cholesterol
- triglyceride
- Body weight
- waist circumference
