Chronic Kidney Diseases Clinical Trial
— REHABIMUSOfficial title:
Assessment of Professional Practices in Muscle Rehabilitation of Chronic Hemodialysis
| Verified date | November 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | November 10, 2021 |
| Est. primary completion date | November 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Uhmontpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in functional autonomy (frailty) after training | Change in functional autonomy (frailty) after training | 4 weeks after inclusion | |
| Primary | Change in functional autonomy (frailty) after training | Change in functional autonomy (frailty) after training | 12 weeks after inclusion | |
| Primary | 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 | |
| Primary | 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 | Change in risk of falling after training | Change in risk of falling after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in muscle strength and mass after training | Change in muscle strength and mass after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in endurance after training | Change in endurance after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in physical activity after training | Change in physical activity after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in quality of dialysis after training | Change in quality of dialysis after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in nutritional status after training | Change in nutritional status after training | 4, 12, 16 and 32 weeks after inclusion | |
| Secondary | Change in neuromuscular sensitivity after training | Change in neuromuscular sensitivity after training | 4, 12, 16 and 32 weeks after inclusion |
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