NCT03671343Unknown不适用
Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
研究概览
简要总结
Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.
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
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •man or woman
- •age over 70 years
- •CKD stage 3B, 4 or 5 or a DFG <45ml / min according to CKD-EPI formula
- •an SPPB (Short Physical Performance Battery test )<10
- •having received a complete and loyal information and having given his written and informed consent.
- •ability to rehabilitate
排除标准
- •Subject not presenting previous inclusion criteria
- •General condition not compatible for the realization of physical rehabilitation
- •Patient protected under the terms of the law.
- •Inability to respect the follow-up of the study for geographical, social or psychological reasons.
- •depression or other psychiatric disorder
- •Refusal to participate in the study
- •Absence of affiliation to the social security system
- •Subject in a exclusion period of an other study
结局指标
主要结局
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
时间窗: Baseline and 3 months
次要结局
- Nutritional parameter: Albuminemia(Baseline,3 and 6 months)
- Nutritional parameter: bioimpedancemetry(Baseline,3 and 6 months)
- Muscle strength evaluated by Hand Grip strength test(Baseline,3 and 6 months)
- Nutritional parameter: Prealbuminemia(Baseline,3 and 6 months)
- Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)(Baseline,3 and 6 months)
- Nutritional parameter: Body mass index(Baseline,3 and 6 months)
研究者
研究点 (4)
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