Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Device: respiratory rehabilitation using Powerbreathe
- Registration Number
- NCT02726672
- Lead Sponsor
- Lille Catholic University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Respiratory rehabilitation respiratory rehabilitation using Powerbreathe Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks
- Primary Outcome Measures
Name Time Method Fatigue graded according to EMIF-SEP questionnaire 3 months EMIF-SEP questionnaire (French valid version of the Fatigue Impact Scale, self-administered questionnaire to measure fatigue in multiple sclerosis patients)
- Secondary Outcome Measures
Name Time Method Sleep disorders graded according to the Epworth Sleepiness Scale 3 months Quality of life graded according to the SEP-59 questionnaire 3 months SEP-59 questionnaire (french validated self-administered questionnaire to assess quality of life in multiple sclerosis patients)
Maximal inspiratory pressure graded according to the Black and Hyatt method 3 months respiratory manometer according to Black and Hyatt method
Forced vital capacity (FVC) graded with a portable spirometer 3 months Tidal volume graded with a portable spirometer 3 months FEV1/ FVC ratio graded with a portable spirometer 3 months Energy consumption during repeated effort 3 months Metamax 3B
Depression graded according to the French version of the Beck Depression Inventory Fast-Screen 3 months French version of the Beck Depression Inventory Fast-Screen, validated scale in multiple sclerosis
Maximal expiratory pressure graded according to Black and Hyatt method 3 months respiratory manometer according to Black and Hyatt method
Forced expiratory volume in one second (FEV1) graded with a portable spirometer 3 months Swallowing problems graded according to the DYMUS score 3 months Level of disability graded by the EDSS (Expanded Disability Status Scale) 3 months These functional parameters will enable the assessment of the level of disability by a clinical examination
Collection of the drug treatments received evaluated by a questionnaire 3 months
Trial Locations
- Locations (1)
Hospital Group of the Catholic Institute of Lille
🇫🇷Lomme, France