Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Improvement in gait speed and functional status in sarcopenic older women
研究概览
简要总结
Aging is characterized by a progressive loss of multiple physical and cognitive abilities. From these changes, the most important one is the loss of muscle mass, which has been called "sarcopenia". Resistance exercise is a therapeutic approach for sarcopenia, nevertheless there is no universal consensus. Therefore, this research is interested in determining the effect of a resistance exercise program on physical performance and/or functional status in sarcopenic older women. The main study hypothesis is that a program of resistance exercise will improve physical performance and functional status in sarcopenic older women compared against general recommendations.
This is a single-blind, controlled clinical trial, including women> 70 years, living in the community with sarcopenia. Those who agree to participate, will be randomly assigned to one of the following groups:
- Resistance Exercise Group
- General Recommendations Group (control) The study will last 24 weeks, with 4 measurements performed at baseline, week 6, 12 and 24. Multilevel models (random effects) will be constructed for the comparison between the two groups. Tests will be conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved by the local ethics committee.
详细描述
Study withdrawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass composition by BIA with skeletal muscle mass <6.76kg/m2
- •Speed gait of <0.8m/sec
- •Handgrip strength (adjusted for BMI) less than 20kg
排除标准
- •Current diagnosis of malnutrition (BMI <19kg/m2)
- •Decompensated heart failure (NYHA III or IV)
- •Hemiplegia or hemiparesis due to cerebral vascular disease
- •Exacerbation of chronic obstructive pulmonary disease
- •Dementia (any type, moderate or severe stage)
- •Uncontrolled diabetes mellitus (glycosylated hemoglobin >8%)
- •Severe pain in hips, knees or ankles
- •Fracture of lower limb in the last 6 months
- •Myocardial infarction within the past 6 months
- •Severe hypertension (SBP > 180mmHg or DBP > 110 mmHg)
- •Orthostatic hypotension
结局指标
主要结局
Improvement in gait speed and functional status in sarcopenic older women
时间窗: improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24
次要结局
- Increase in muscle mass in sarcopenic older women(Increase in muscle mass in sarcopenic older women in week 24)
研究者
José Alberto Ávila Funes
PhD
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
