Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis (AIRSEP)

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: respiratory rehabilitation using Powerbreathe

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lomme, France, 59462
    • Hospital Group of the Catholic Institute of Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory rehabilitation; Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks	Device: respiratory rehabilitation using Powerbreathe; 10 minutes 2 times a day : 30 inspirations per session during 10 weeks
No Intervention: control group; No respiratory rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Cécile Donzé, MD, Hospital Group of the Catholic Institute of Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: rehabilitation; multiple sclerosis; inspiratory muscles
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Respiration Disorders; Multiple Sclerosis; Sclerosis; Respiratory Aspiration
• Other Study ID Numbers: RC-P0043; 2015-A01451-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO