Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— AIRSEP  

Official title:

Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02726672
• Other study ID #: RC-P0043
• Secondary ID: 2015-A01451-48
• Status: Terminated
• Phase: N/A
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Respiratory Aspiration
• Sclerosis

Intervention

Device:
• respiratory rehabilitation using Powerbreathe
10 minutes 2 times a day : 30 inspirations per session during 10 weeks

Locations

Country	Name	City	State
France	Hospital Group of the Catholic Institute of Lille	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Sleep disorders graded according to the Epworth Sleepiness Scale		3 months
Secondary	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)	3 months
Secondary	Maximal inspiratory pressure graded according to the Black and Hyatt method	respiratory manometer according to Black and Hyatt method	3 months
Secondary	Maximal expiratory pressure graded according to Black and Hyatt method	respiratory manometer according to Black and Hyatt method	3 months
Secondary	Forced vital capacity (FVC) graded with a portable spirometer		3 months
Secondary	Tidal volume graded with a portable spirometer		3 months
Secondary	Forced expiratory volume in one second (FEV1) graded with a portable spirometer		3 months
Secondary	FEV1/ FVC ratio graded with a portable spirometer		3 months
Secondary	Energy consumption during repeated effort	Metamax 3B	3 months
Secondary	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
Secondary	Swallowing problems graded according to the DYMUS score		3 months
Secondary	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
Secondary	Collection of the drug treatments received evaluated by a questionnaire		3 months