Effects of Exercise on Multiple Risk Factors and Health Costs in Community Living Elderly Women. The Senior Fitness and Prevention Study (SEFIP)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 246
- 试验地点
- 4
- 主要终点
- falls after 18 months
研究概览
简要总结
The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.
详细描述
The human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. Osteoporosis, diabetes type II and arteriosclerosis are diseases known to correlate with age. Participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". Unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. However, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. Furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of Germany. We hypothesize that regular exercise
- significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
- significantly reduces health costs in elderly community living women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Community living Caucasian woman ≥ 65 years; live expectation > 2 years
排除标准
- •secondary osteoporosis
- •CVD-events including stroke
- •Participation in other studies
- •Medication with impact on bone during the last 2 years:
- •bisphosphonates
- •parathormone
- •strontium
- •HRT, anabolic steroids
- •calcitonin
- •natriumflourides
- •active Vit-D-metabolites
- •cortisone > 5 mg/d
- •medication with impact on falls
- •low physical performance (<50 Watt during ergometry)
- •excessive alcohol-intake
结局指标
主要结局
falls after 18 months
时间窗: daily records, analysis after 18 months
Bone parameters after 6, 12 and 18 months
时间窗: baseline, 6, 12, 18 month-control
health costs after 18 months
时间窗: baseline 18 month control
次要结局
- Functional status after 6, 12, and 18 months
- Quality of live after 12 and 18 months
- CHD- and diabetes-risk-factors (bodyfat, blood lipids, glucose, blood pressure) after 6, 12 and 18 months