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临床试验/NCT01829009
NCT01829009撤回不适用

Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

National Institute of Medical Sciences and Nutrition, Salvador Zubiran2 个研究点 分布在 1 个国家开始时间: 2013年4月11日最近更新:
适应症

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:

  1. Resistance Exercise Group
  2. 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Study withdrawn.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

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

发起方
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

José Alberto Ávila Funes

PhD

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

研究点 (2)

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