Effects of Exercise on Fracture Risk, Bone Mineral Density and Falls in Postmenopausal Women. The Long-term Erlangen Fitness and Prevention Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Bone Mineral Density at Lumbar Spine and Proximal Femur
研究概览
简要总结
The study determines the long-term effect of exercise on osteoporotic fracture risk. Since actually no controlled supervised exercise study exceeds the time frame of 4 years, knowledge concerning the long-term effect of exercise on fractures and fracture-risk factors is scarce. Within the Erlanger Fitness and Osteoporosis Study (EFOPS, an ongoing controlled exercise study with currently 16 years of supervised exercise with 45-50 osteopenic, early-postmenopausal women in exercise and sedentary control group each, the investigators therefore focus on overall-fractures, Bone Mineral Density and falls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participants of the EFOPS-study,
- •12 years of exercise training according to the EFOPS-protocol (exercise).
排除标准
- •medication and diseases affecting bone metabolism,
- •inflammable diseases,
- •cardiovascular diseases,
- •start of relevant physical exercise programs beside the EFOPS protocol.
结局指标
主要结局
Bone Mineral Density at Lumbar Spine and Proximal Femur
时间窗: 16 year follow-up
As assessed by Dual-Energy X-ray Absorptiometry (DEXA)
overall-fractures (low-trauma)
时间窗: 16 year follow-up
As assessed by questionnaire and structured interview
次要结局
- 10-year coronary heart disease (CHD) risk(16 year follow-up)
- Metabolic Syndrome Z-Score(16 year follow-up)
研究者
Wolfgang Kemmler
Professor Dr. Wolfgang Kemmler
University of Erlangen-Nürnberg Medical School