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

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.

Study Overview

• Status: Unknown
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: Self-rehabilitation program and protein supplement

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle SAURET; Phone Number: +33 1 56 61 67 05; Email: isabelle.sauret@imm.fr
• Study Contact Backup: Name: Caroline RIX; Phone Number: +33 1 56 61 63 71; Email: caroline.rix@imm.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Isabelle SAURET; Phone Number: + 33 1 56 61 67 05; Email: isabelle.sauret@imm.fr
    • Contact: Caroline RIX; Phone Number: + 33 1 56 61 63 71; Email: caroline.rix@imm.fr
    • Principal Investigator: Martine GAYRAUD LARMIGNAT, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Arm 1: Self-rehabilitation arm; Self-rehabilitation arm

Behavioral: Self-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular status evaluation	Change in muscle mass measured with Bio-Impedance analysis	3 months
Muscular status evaluation	Performance in muscle mass measured with Short Physical Performance Battery	3 months
Muscular status evaluation	Force in muscle mass measured with Grip test	3 months
Autonomy degree evaluation	Change in autonomy measured with Barthel Index	3 months
Quality of life evaluation	Change in quality of life measured with Médical Outcomes Study Short Form 36	3 months

Collaborators and Investigators

• Sponsor: Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: MED-01-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No