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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01451-48 | Other Identifier | ANSM |
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lack of recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory rehabilitation | Experimental | Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks |
|
| control group | No Intervention | No respiratory rehabilitation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| respiratory rehabilitation using Powerbreathe | Device | 10 minutes 2 times a day : 30 inspirations per session during 10 weeks |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cécile Donzé, MD | Hospital Group of the Catholic Institute of Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Group of the Catholic Institute of Lille | Lomme | 59462 | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |