Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis (AIRSEP)

Lille Catholic University

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Device: respiratory rehabilitation using Powerbreathe

Study type: Interventional

Funder types: Other

Identifiers

NCT02726672

RC-P0043

2015-A01451-48 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Respiratory rehabilitation

Experimental group

Description:

Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks

Treatment:

Device: respiratory rehabilitation using Powerbreathe

control group

No Intervention group

Description:

No respiratory rehabilitation