Effects of DHEA/Exercise on Bone, Muscle and Balance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Muscle strength, bone turnover markers
研究概览
简要总结
The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.
详细描述
Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response.
The specific aims of this study are:
- To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty
- To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
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
- •Women over age 65 years
- •Bone mineral density t-score less than -1
- •At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
- •DHEAS levels less than 550 ng/dl
- •Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
- •Mammogram within the preceding 12 months
排除标准
- •Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
- •Use of androgen or estrogen in the preceding year
- •Use of psychiatric medications including antipsychotic medications and SSRI
- •Metastatic or advanced cancer (other than skin cancer)
- •History of breast cancer
- •Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months
结局指标
主要结局
Muscle strength, bone turnover markers
时间窗: baseline, 3 month and 6 months
次要结局
- Changes in activities of daily living, cognitive and emotional function(baseline and 6 months)
- Laboratory tests to measure factors that may reflect or influence changes in bone metabolism(baseline and 6 months)