Physical Rehabilitation and Chronic Kidney Disease (IMPREPA)

Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease; Sarcopenia; Older
• Intervention / Treatment: Behavioral: Physical rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd
  • Pierre-Bénite, France, 69310
    • Service de Néphrologie, Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention : Physical rehabilitation; 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.	Behavioral: Physical rehabilitation; It will benefit from an initial and final geriatric assessment, an initial dietary balance and a personalized treatment in physical activities adapted for 3 months by an Educator in Adapted Physical Activities.
No Intervention: Control : optimized medical treatment; The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Nutritional parameter: Albuminemia	Baseline,3 and 6 months
Nutritional parameter: Prealbuminemia	Baseline,3 and 6 months
Nutritional parameter: Body mass index	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: chronic kidney disease; sarcopenia; older
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Kidney Diseases; Renal Insufficiency, Chronic; Sarcopenia
• Other Study ID Numbers: 69HCL17_0598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No