Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

NCT ID: NCT02726672

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-11-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Respiratory rehabilitation

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

Group Type: EXPERIMENTAL

respiratory rehabilitation using Powerbreathe

Intervention Type: DEVICE

10 minutes 2 times a day : 30 inspirations per session during 10 weeks

control group

No respiratory rehabilitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

respiratory rehabilitation using Powerbreathe

10 minutes 2 times a day : 30 inspirations per session during 10 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile Donzé, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Group of the Catholic Institute of Lille

Locations

Hospital Group of the Catholic Institute of Lille

Lomme, , France

Countries

France

Other Identifiers

2015-A01451-48

Identifier Type: OTHER

Identifier Source: secondary_id

RC-P0043

Identifier Type: -

Identifier Source: org_study_id