NCT03671343

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 10, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

October 10, 2017

Last Update Submit

September 13, 2018

Conditions

SarcopeniaChronic Kidney DiseaseOlder

Keywords

sarcopeniachronic kidney diseaseolder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Nutritional parameter: Albuminemia

    Baseline,3 and 6 months

  • Nutritional parameter: Prealbuminemia

    Baseline,3 and 6 months

  • Nutritional parameter: Body mass index

    Baseline,3 and 6 months

  • Nutritional parameter: bioimpedancemetry

    Baseline,3 and 6 months

  • Muscle strength evaluated by Hand Grip strength test

    Baseline,3 and 6 months

  • +1 more secondary outcomes

Study Arms (2)

Intervention : Physical rehabilitation

EXPERIMENTAL

The Arm "Physical rehabilitation" will benefit from the implementation of the "Loss of Mobility Prevention" program set up in the Department of Aging Medicine of the Center Hospitalier Lyon Sud (CHLS) of Pr BONNEFOY.

Behavioral: Physical rehabilitation

Control : optimized medical treatment

NO INTERVENTION

The Arm "Optimized medical treatment" will not benefit from the implementation of the "Loss of Mobility Prevention" program.

Interventions

Physical rehabilitationBEHAVIORAL

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.

Intervention : Physical rehabilitation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd

Pierre-Bénite, 69310, France

Location

Service de Néphrologie, Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

SarcopeniaRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic Processes

Central Study Contacts

Laëtitia KOPPE, MD

CONTACT

0472678715laetitia.koppe@chu-lyon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

September 14, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

September 14, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)