Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.

Detailed Description
-----------------
Patients will be informed about the study procedures during a follow-up consultation or an hospitalization in a Physical and Rehabilitation Medicine Unit. If they give their informed consent to participate in the study, an investigator will randomize them into one of the 2 arms of the study. This study consists of 3 visits. The first visit (inclusion) is planned at day 0, the second visit 10 weeks later and the third 3 months after day 0. A patient who is randomized in the experimental arm will have to follow 10 weeks of rehabilitation of the inspiratory muscles at home between first and second visit. During this period, investigators will call these patients once a week to assess the compliance with the rehabilitation. The patients who have been randomized in the control group will not follow this rehabilitation program.

Official Title
-----------------
Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: respiratory rehabilitation using Powerbreathe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with remitting or progressive multiple sclerosis defined by McDonald criteria revised in 2005, with an EDSS between 6 and 7,5 Aged between 18 and 65 years Patients able to maintain the Powerbreathe Not to have had a flare-up since at least 6 weeks Patients at least 4 weeks since a corticoid bolus Patients at least 6 weeks since a botulinum toxin injection Patients at least 4 weeks since a pulmonary infection Questionnaire EMIF-SEP >= 55 Patients given their informed consent Patients who benefit or are affiliated to a social security regimen Exclusion Criteria: Patients with neurologic antecedents other that multiple sclerosis Patients with respiratory disorders other than those induced by multiple sclerosis Patients with orthopedic, cardiac, and rheumatologic invalidating antecedents Patients with comprehension or cognitive disorders impeding the realization of rehabilitation Pregnant women Patients under legal guardianship, or safeguard of justice Patients participating or planning participate within the 3 months of the study to another clinical research project

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory rehabilitation<br>Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks | Device: respiratory rehabilitation using Powerbreathe<br>* 10 minutes 2 times a day : 30 inspirations per session during 10 weeks<br>|
| No Intervention: control group<br>No respiratory rehabilitation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue graded according to EMIF-SEP questionnaire | EMIF-SEP questionnaire (French valid version of the Fatigue Impact Scale, self-administered questionnaire to measure fatigue in multiple sclerosis patients) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep disorders graded according to the Epworth Sleepiness Scale |  | 3 months | 
| Quality of life graded according to the SEP-59 questionnaire | SEP-59 questionnaire (french validated self-administered questionnaire to assess quality of life in multiple sclerosis patients) | 3 months | 
| Maximal inspiratory pressure graded according to the Black and Hyatt method | respiratory manometer according to Black and Hyatt method | 3 months | 
| Maximal expiratory pressure graded according to Black and Hyatt method | respiratory manometer according to Black and Hyatt method | 3 months | 
| Forced vital capacity (FVC) graded with a portable spirometer |  | 3 months | 
| Tidal volume graded with a portable spirometer |  | 3 months | 
| Forced expiratory volume in one second (FEV1) graded with a portable spirometer |  | 3 months | 
| FEV1/ FVC ratio graded with a portable spirometer |  | 3 months | 
| Energy consumption during repeated effort | Metamax 3B | 3 months | 
| Depression graded according to the French version of the Beck Depression Inventory Fast-Screen | French version of the Beck Depression Inventory Fast-Screen, validated scale in multiple sclerosis | 3 months | 
| Swallowing problems graded according to the DYMUS score |  | 3 months | 
| Level of disability graded by the EDSS (Expanded Disability Status Scale) | These functional parameters will enable the assessment of the level of disability by a clinical examination | 3 months | 
| Collection of the drug treatments received evaluated by a questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inspiratory muscles, multiple sclerosis, rehabilitation