NCT00663104终止3 期
Effect of Exercise and Exercise + Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause
University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Bone Mineral Density
研究概览
简要总结
The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1-3 years early postmenopausal
- •Caucasian race
排除标准
- •CHD-diseases
- •thrombosis, embolism
- •fractures at lumbar spine or hip
- •secondary osteoporosis
- •hyperparathyroidism
- •medication, diseases with impact on muscle or bone
- •cancer and hormone derived malign diseases
- •weight reduction of > 5 kg during the last 6 months
结局指标
主要结局
Bone Mineral Density
时间窗: baseline, 12 month
次要结局
- body composition(baseline, 12 month)
- blood lipids, glucose(baseline, 12 month)
- blood pressure(baseline, 12 month)
- 10 year CHD-risk(baseline, 12 months)
- menopausal complaints(baseline, 12 months)
研究者
Wolfgang Kemmler
Principal Investigator
University of Erlangen-Nürnberg Medical School
研究点 (2)
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