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临床试验/NCT03671343
NCT03671343Unknown不适用

Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
2
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

研究组 & 干预措施

Intervention : Physical rehabilitation

Experimental

The Arm "Physical rehabilitation" will benefit from the implementation of the "Loss of Mobility Prevention" program set up in the Department of Aging Medicine of the Center Hospitalier Lyon Sud (CHLS) of Pr BONNEFOY.

干预措施: Physical rehabilitation (Behavioral)

Control : optimized medical treatment

No Intervention

The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program.

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: Prealbuminemia(Baseline,3 and 6 months)
  • 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)
  • 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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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