NCT04820140

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

March 19, 2021

Last Update Submit

November 12, 2021

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease patient on dialysis (stage 5D)Muscle mass and strengthTrainingSurvival

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Change in risk of falling after training

    4, 12, 16 and 32 weeks after inclusion

  • Change in muscle strength and mass after training

    4, 12, 16 and 32 weeks after inclusion

  • Change in endurance after training

    4, 12, 16 and 32 weeks after inclusion

  • Change in physical activity after training

    4, 12, 16 and 32 weeks after inclusion

  • Change in quality of dialysis after training

    4, 12, 16 and 32 weeks after inclusion

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

Lymphatic drainagePROCEDURE

Lymphatic drainage

muscle strengthening program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients issued from dialysis units (clinic)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jean-Paul CRISTOL, Prof

    CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 29, 2021

Study Start

April 20, 2021

Primary Completion

November 1, 2021

Study Completion

November 10, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

FR(1)