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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04820140
Other study ID # RECHMPL21_0031
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2021
Est. completion date November 10, 2021

Study information

Verified date November 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Lymphatic drainage
Lymphatic drainage

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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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