Physical Rehabilitation and Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— IMPREPA  

Official title:

Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03671343
• Other study ID #: 69HCL17_0598
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Hospices Civils de Lyon
• Contact: Laëtitia KOPPE, MD
• Phone: 0472678715
• Email: laetitia.koppe[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Older
• Renal Insufficiency, Chronic
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nutritional parameter: Albuminemia		Baseline,3 and 6 months
Secondary	Nutritional parameter: Prealbuminemia		Baseline,3 and 6 months
Secondary	Nutritional parameter: Body mass index		Baseline,3 and 6 months
Secondary	Nutritional parameter: bioimpedancemetry		Baseline,3 and 6 months
Secondary	Muscle strength evaluated by Hand Grip strength test		Baseline,3 and 6 months
Secondary	Quality of life evaluated by the questionnaire SF-36 (36-item medical outcomes study Short-Form health survey)		Baseline,3 and 6 months