Fatigue and Inspiratory Muscles Training in Patients With Multiple Scl
Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities
What it found
The trial ended early for another reason (see below).
Reason given: lack of recruitment
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- respiratory rehabilitation using Powerbreathe
What it measured
Main measures
Fatigue graded according to EMIF-SEP questionnaire
3 months
Fatigue
Other measures (13)
Sleep disorders graded according to the Epworth Sleepiness Scale
3 months
Mood and sleepQuality of life graded according to the SEP-59 questionnaire
3 months
Quality of life (reported by participants)Maximal inspiratory pressure graded according to the Black and Hyatt method
3 months
Physical functionMaximal expiratory pressure graded 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
3 months
Depression graded according to the French version of the Beck Depression Inventory Fast-Screen
3 months
Mood and sleep
Who could take part
Progressive MS · 18 to 65 · EDSS 6 to 7
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Feb 2016
Main results due
May 2018
Finished
Nov 2018