Physical Rehabilitation and Chronic Kidney Disease

Not Applicable

• Conditions: Chronic Kidney Disease; Older; Sarcopenia

• Registration Number: NCT03671343
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-13
• Last Update Submitted: 2018-09-13
• Study First Posted: 2018-09-14
• Last Update Posted: 2018-09-14
• Study Start: 2018-12
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months	Baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
Nutritional parameter: bioimpedancemetry	Baseline,3 and 6 months
Muscle strength evaluated by Hand Grip strength test	Baseline,3 and 6 months
Nutritional parameter: Albuminemia	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

Trial Locations

Locations (2)

Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd; 🇫🇷 Pierre-Bénite, France

Service de Néphrologie, Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France