Back to resultsPhysical Rehabilitation and Chronic Kidney Disease (IMPREPA)
Primary Purpose
Sarcopenia, Chronic Kidney Disease, Older
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, chronic kidney disease, older
Eligibility Criteria
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
Sites / Locations
- Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd
- Service de Néphrologie, Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention : Physical rehabilitation
Control : optimized medical treatment
Arm Description
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.
The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program.
Outcomes
Primary Outcome Measures
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
Secondary Outcome Measures
Nutritional parameter: Albuminemia
Nutritional parameter: Prealbuminemia
Nutritional parameter: Body mass index
Nutritional parameter: bioimpedancemetry
Muscle strength evaluated by Hand Grip strength test
Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)
Full Information
NCT ID
NCT03671343
First Posted
October 10, 2017
Last Updated
September 13, 2018
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03671343
Brief Title
Physical Rehabilitation and Chronic Kidney Disease
Acronym
IMPREPA
Official Title
Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Chronic Kidney Disease, Older
Keywords
sarcopenia, chronic kidney disease, older
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention : Physical rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control : optimized medical treatment
Arm Type
No Intervention
Arm Description
The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program.
Intervention Type
Behavioral
Intervention Name(s)
Physical rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline distance travelled (in meters) during the 6-minute walking distance (6MWD) test (muscular performance), at 3 months
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Nutritional parameter: Albuminemia
Time Frame
Baseline,3 and 6 months
Title
Nutritional parameter: Prealbuminemia
Time Frame
Baseline,3 and 6 months
Title
Nutritional parameter: Body mass index
Time Frame
Baseline,3 and 6 months
Title
Nutritional parameter: bioimpedancemetry
Time Frame
Baseline,3 and 6 months
Title
Muscle strength evaluated by Hand Grip strength test
Time Frame
Baseline,3 and 6 months
Title
Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)
Time Frame
Baseline,3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laëtitia KOPPE, MD
Phone
0472678715
Ext
+33
Email
laetitia.koppe@chu-lyon.fr
Facility Information:
Facility Name
Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, MD
Phone
0472863704
Ext
+33
Email
marc.bonnefoy@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Marc BONNEFOY, MD
Facility Name
Service de Néphrologie, Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laëtitia KOPPE, MD
Phone
0472678715
Ext
+33
Email
laetitia.koppe@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Laëtitia KOPPE, MD
First Name & Middle Initial & Last Name & Degree
Denis FOUQUE, MD
First Name & Middle Initial & Last Name & Degree
Mathilde NOUVIER, Md
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physical Rehabilitation and Chronic Kidney Disease
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