Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis (REHABIMUS)

Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of a muscle strengthening program (training against resistance vs endurance training by elliptical bike) during a observational period (12 weeks per program) on frailty, risk of falling, muscle strength and mass, endurance, physical activity, quality of dialysis, nutritional status and neuromuscular sensitivity.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Procedure: Lymphatic drainage

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34290
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients issued from dialysis units (clinic)

Description

Inclusion criteria:

• Chronic Kidney Disease patient on dialysis (stage 5D) for more than 3 months
• Age > 18 years old
• Stable clinical condition
• Absence of musculoskeletal disorders

Exclusion criteria:

• Cardiovascular contraindication
• Amputation of lower limb not allowing use of elliptical bike

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
muscle strengthening program; All patients will be receiving a muscle strengthening program consisting in both a training against resistance and an endurance training by elliptical bike during an observational period of 12 weeks for each treatment. Each training program will be preceded by a 4-week period of lymphatic drainage in order to improve neuromuscular sensitivity.	Procedure: Lymphatic drainage; Lymphatic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in functional autonomy (frailty) after training	Change in functional autonomy (frailty) after training	4 weeks after inclusion
Change in functional autonomy (frailty) after training	Change in functional autonomy (frailty) after training	12 weeks after inclusion
Change in functional autonomy (frailty) after training	Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).	16 weeks after inclusion
Change in functional autonomy (frailty) after training	Change in functional autonomy (frailty) after training and endurance training by elliptical bike during an observational period (12 weeks per program).	32 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in risk of falling after training	Change in risk of falling after training	4, 12, 16 and 32 weeks after inclusion
Change in muscle strength and mass after training	Change in muscle strength and mass after training	4, 12, 16 and 32 weeks after inclusion
Change in endurance after training	Change in endurance after training	4, 12, 16 and 32 weeks after inclusion
Change in physical activity after training	Change in physical activity after training	4, 12, 16 and 32 weeks after inclusion
Change in quality of dialysis after training	Change in quality of dialysis after training	4, 12, 16 and 32 weeks after inclusion
Change in nutritional status after training	Change in nutritional status after training	4, 12, 16 and 32 weeks after inclusion
Change in neuromuscular sensitivity after training	Change in neuromuscular sensitivity after training	4, 12, 16 and 32 weeks after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2021
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): November 10, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (ACTUAL): March 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Training; Survival; Chronic Kidney Disease patient on dialysis (stage 5D); Muscle mass and strength
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: RECHMPL21_0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

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