Clinical trial NCT02726672: Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis
Official title: Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: inspiratory muscles
multiple sclerosis
rehabilitation
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Fatigue graded according to EMIF-SEP questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Sleep disorders graded according to the Epworth Sleepiness Scale
timeFrame: 3 months
measure: Quality of life graded according to the SEP-59 questionnaire
timeFrame: 3 months
measure: Maximal inspiratory pressure graded according to the Black and Hyatt method
timeFrame: 3 months
measure: Maximal expiratory pressure graded according to Black and Hyatt method
timeFrame: 3 months
measure: Forced vital capacity (FVC) graded with a portable spirometer
timeFrame: 3 months
measure: Tidal volume graded with a portable spirometer
timeFrame: 3 months
measure: Forced expiratory volume in one second (FEV1) graded with a portable spirometer
timeFrame: 3 months
measure: FEV1/ FVC ratio graded with a portable spirometer
timeFrame: 3 months
measure: Energy consumption during repeated effort
timeFrame: 3 months
measure: Depression graded according to the French version of the Beck Depression Inventory Fast-Screen
timeFrame: 3 months
measure: Swallowing problems graded according to the DYMUS score
timeFrame: 3 months
measure: Level of disability graded by the EDSS (Expanded Disability Status Scale)
timeFrame: 3 months
measure: Collection of the drug treatments received evaluated by a questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hospital Group of the Catholic Institute of Lille
Study officials:
affiliation: Hospital Group of the Catholic Institute of Lille
name: Cécile Donzé, MD
role: PRINCIPAL_INVESTIGATOR
References: