NCT03834103

Brief Summary

Loss of autonomy among elderly during and after hospitalisation is a well-known problem. Patient suffering of sarcopenia (decreasing in muscle mass and function) are more likely not to recover their previous autonomy. Studies have shown that physical exercise, especially resistance exercises, is the most efficient known treatment of sarcopenia. Several institution-based rehabilitation programs had been implemented in this purpose. On the other hand, some studies have shown that home-based self-rehabilitation can be as efficient as institution-based rehabilitation, for example in stroke, cardiac failure and COPD rehabilitation. The investigators propose to set up a home-based self-rehabilitation program to fight against sarcopenia and hence increasing autonomy among elderly. This study aimed to establish the feasibility of such a program.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 7, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 21, 2019

Last Update Submit

February 6, 2019

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (3)

  • Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients

    Measured from program adherence using a patient notebook

    3 months

  • Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients

    Measured from patient satisfaction using a satisfaction scale

    3 months

  • Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients

    Measured from medical time required by phone call

    3 months

Secondary Outcomes (5)

  • Muscular status evaluation

    3 months

  • Muscular status evaluation

    3 months

  • Muscular status evaluation

    3 months

  • Autonomy degree evaluation

    3 months

  • Quality of life evaluation

    3 months

Study Arms (1)

Arm 1: Self-rehabilitation arm

OTHER

Self-rehabilitation arm

Behavioral: Self-rehabilitation program and protein supplement

Interventions

Self-rehabilitation program and protein supplementBEHAVIORAL

Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation. The rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up.

Arm 1: Self-rehabilitation arm

Eligibility Criteria

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

You may qualify if:

  • Patients aged 70 or older
  • Non-institutionnalised patients
  • Patients suffering of sarcopenia during hospitalisation (assessed by the Short Physical Performance Battery, Bio-Impedance analysis and griptest)
  • Patients hospitalised in the service of Internal Medicine of Institut Mutualiste Montsouris
  • Patients returning at home after hospitalisation
  • Patients who gave their written consent
  • Patients who benefits from a social security coverage

You may not qualify if:

  • Patients suffering from a severe medical condition not allowing them to follow a physical exercise program
  • Palliative care patients
  • Patients without the musculo-squelettic capacity to follow the program : 4/4 on seated postural stability scale ; no motor deficit on lower limb muscular testing ; quadricipital locking when standing
  • Patients with severe cognitive disorders (according to MMSE score adapted to socio-cultural level and age)
  • Patients who live more than 150 km away
  • Patients following specific physiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Mutualiste Montsouris

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Isabelle SAURET

CONTACT

+33 1 56 61 67 05isabelle.sauret@imm.fr

Caroline RIX

CONTACT

+33 1 56 61 63 71caroline.rix@imm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

February 7, 2019

Study Start

October 9, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

February 7, 2019

Record last verified: 2019-01

Locations

FR(1)