CClinicalTrials.gg
Status unknownNCT03834103FREESARCUpdated Feb 7, 2019

Feasibility Study of a Post-hospitalization Self-rehabilitation Program for Elderly Suffering of Sarcopenia

An interventional study of Self-rehabilitation program and protein supplement in Sarcopenia, sponsored by Institut Mutualiste Montsouris. Status unknown at 1 site in France. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by Institut Mutualiste Montsouris · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2018, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Institut Mutualiste Montsouris is the lead sponsor of 35 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Arm 1: Self-rehabilitation arm

    Self-rehabilitation arm

    Behavioral: Self-rehabilitation program and protein supplement

Interventions

  • BehavioralSelf-rehabilitation program and protein supplement

    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.

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What researchers measure

Primary outcomes

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

    Measured from program adherence using a patient notebook

    Time frame: 3 months

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

    Measured from patient satisfaction using a satisfaction scale

    Time frame: 3 months

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

    Measured from medical time required by phone call

    Time frame: 3 months

Secondary outcomes

  1. Muscular status evaluation

    Change in muscle mass measured with Bio-Impedance analysis

    Time frame: 3 months

  2. Muscular status evaluation

    Performance in muscle mass measured with Short Physical Performance Battery

    Time frame: 3 months

  3. Muscular status evaluation

    Force in muscle mass measured with Grip test

    Time frame: 3 months

  4. Autonomy degree evaluation

    Change in autonomy measured with Barthel Index

    Time frame: 3 months

  5. Quality of life evaluation

    Change in quality of life measured with Médical Outcomes Study Short Form 36

    Time frame: 3 months

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Study locations

1 of 1 sites recruiting
  • Institut Mutualiste Montsouris
    Paris, 75014, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03834103
Lead sponsor
Institut Mutualiste Montsouris
Responsible party
Sponsor
First posted
Feb 7, 2019
Start date
Oct 9, 2018
Primary completion
Mar 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Feb 7, 2019

Study contacts

Isabelle SAURET
Contact
isabelle.sauret@imm.fr
+33 1 56 61 67 05
Caroline RIX
Contact
caroline.rix@imm.fr
+33 1 56 61 63 71

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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