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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
respiratory rehabilitation using Powerbreathe
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring inspiratory muscles, multiple sclerosis, rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Group of the Catholic Institute of Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Respiratory rehabilitation

control group

Arm Description

Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks

No respiratory rehabilitation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
March 22, 2016
Last Updated
November 20, 2018
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02726672
Brief Title
Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis
Acronym
AIRSEP
Official Title
Fatigue and Inspiratory Muscles Training Against Resistance in Patients With Multiple Sclerosis With Severe Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
inspiratory muscles, multiple sclerosis, rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory rehabilitation
Arm Type
Experimental
Arm Description
Respiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks
Arm Title
control group
Arm Type
No Intervention
Arm Description
No respiratory rehabilitation
Intervention Type
Device
Intervention Name(s)
respiratory rehabilitation using Powerbreathe
Intervention Description
10 minutes 2 times a day : 30 inspirations per session during 10 weeks
Primary Outcome Measure Information:
Title
Fatigue graded according to EMIF-SEP questionnaire
Description
EMIF-SEP questionnaire (French valid version of the Fatigue Impact Scale, self-administered questionnaire to measure fatigue in multiple sclerosis patients)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep disorders graded according to the Epworth Sleepiness Scale
Time Frame
3 months
Title
Quality of life graded according to the SEP-59 questionnaire
Description
SEP-59 questionnaire (french validated self-administered questionnaire to assess quality of life in multiple sclerosis patients)
Time Frame
3 months
Title
Maximal inspiratory pressure graded according to the Black and Hyatt method
Description
respiratory manometer according to Black and Hyatt method
Time Frame
3 months
Title
Maximal expiratory pressure graded according to Black and Hyatt method
Description
respiratory manometer according to Black and Hyatt method
Time Frame
3 months
Title
Forced vital capacity (FVC) graded with a portable spirometer
Time Frame
3 months
Title
Tidal volume graded with a portable spirometer
Time Frame
3 months
Title
Forced expiratory volume in one second (FEV1) graded with a portable spirometer
Time Frame
3 months
Title
FEV1/ FVC ratio graded with a portable spirometer
Time Frame
3 months
Title
Energy consumption during repeated effort
Description
Metamax 3B
Time Frame
3 months
Title
Depression graded according to the French version of the Beck Depression Inventory Fast-Screen
Description
French version of the Beck Depression Inventory Fast-Screen, validated scale in multiple sclerosis
Time Frame
3 months
Title
Swallowing problems graded according to the DYMUS score
Time Frame
3 months
Title
Level of disability graded by the EDSS (Expanded Disability Status Scale)
Description
These functional parameters will enable the assessment of the level of disability by a clinical examination
Time Frame
3 months
Title
Collection of the drug treatments received evaluated by a questionnaire
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Donzé, MD
Organizational Affiliation
Hospital Group of the Catholic Institute of Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Group of the Catholic Institute of Lille
City
Lomme
ZIP/Postal Code
59462
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

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