Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis (AIRSEP)
20. november 2018 opdateret af: Lille Catholic University
Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
46
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Lomme, Frankrig, 59462
- Hospital Group of the Catholic Institute of Lille
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Respiratory rehabilitation
Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks
|
10 minutes 2 times a day : 30 inspirations per session during 10 weeks
|
|
Ingen indgriben: control group
No respiratory rehabilitation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fatigue graded according to EMIF-SEP questionnaire
Tidsramme: 3 months
|
EMIF-SEP questionnaire (French valid version of the Fatigue Impact Scale, self-administered questionnaire to measure fatigue in multiple sclerosis patients)
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sleep disorders graded according to the Epworth Sleepiness Scale
Tidsramme: 3 months
|
3 months
|
|
|
Quality of life graded according to the SEP-59 questionnaire
Tidsramme: 3 months
|
SEP-59 questionnaire (french validated self-administered questionnaire to assess quality of life in multiple sclerosis patients)
|
3 months
|
|
Maximal inspiratory pressure graded according to the Black and Hyatt method
Tidsramme: 3 months
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respiratory manometer according to Black and Hyatt method
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3 months
|
|
Maximal expiratory pressure graded according to Black and Hyatt method
Tidsramme: 3 months
|
respiratory manometer according to Black and Hyatt method
|
3 months
|
|
Forced vital capacity (FVC) graded with a portable spirometer
Tidsramme: 3 months
|
3 months
|
|
|
Tidal volume graded with a portable spirometer
Tidsramme: 3 months
|
3 months
|
|
|
Forced expiratory volume in one second (FEV1) graded with a portable spirometer
Tidsramme: 3 months
|
3 months
|
|
|
FEV1/ FVC ratio graded with a portable spirometer
Tidsramme: 3 months
|
3 months
|
|
|
Energy consumption during repeated effort
Tidsramme: 3 months
|
Metamax 3B
|
3 months
|
|
Depression graded according to the French version of the Beck Depression Inventory Fast-Screen
Tidsramme: 3 months
|
French version of the Beck Depression Inventory Fast-Screen, validated scale in multiple sclerosis
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3 months
|
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Swallowing problems graded according to the DYMUS score
Tidsramme: 3 months
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3 months
|
|
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Level of disability graded by the EDSS (Expanded Disability Status Scale)
Tidsramme: 3 months
|
These functional parameters will enable the assessment of the level of disability by a clinical examination
|
3 months
|
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Collection of the drug treatments received evaluated by a questionnaire
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Cécile Donzé, MD, Hospital Group of the Catholic Institute of Lille
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2016
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Faktiske)
1. november 2018
Datoer for studieregistrering
Først indsendt
22. marts 2016
Først indsendt, der opfyldte QC-kriterier
1. april 2016
Først opslået (Skøn)
4. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RC-P0043
- 2015-A01451-48 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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