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

Sarcopenia Clinical Trial

— FREESARC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03834103
• Other study ID #: MED-01-2018
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: June 2019

Study information

• Verified date: January 2019
• Source: Institut Mutualiste Montsouris
• Contact: Isabelle SAURET
• Phone: +33 1 56 61 67 05
• Email: isabelle.sauret[@]imm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients	Measured from program adherence using a patient notebook	3 months
Primary	Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients	Measured from patient satisfaction using a satisfaction scale	3 months
Primary	Feasability of a post-hospitalization self-rehabilitation program for sarcopenic elderly patients	Measured from medical time required by phone call	3 months
Secondary	Muscular status evaluation	Change in muscle mass measured with Bio-Impedance analysis	3 months
Secondary	Muscular status evaluation	Performance in muscle mass measured with Short Physical Performance Battery	3 months
Secondary	Muscular status evaluation	Force in muscle mass measured with Grip test	3 months
Secondary	Autonomy degree evaluation	Change in autonomy measured with Barthel Index	3 months
Secondary	Quality of life evaluation	Change in quality of life measured with Médical Outcomes Study Short Form 36	3 months