AzTrials
AzTrials

Multiple SclerosisAIRSEPNCT02726672

Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

A study testing respiratory rehabilitation using Powerbreathe in people with Multiple Sclerosis, run by Lille Catholic University at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
respiratory rehabilitation using Powerbreathe
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteFrance
Study dates
Feb 2016to Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hospital Group of the Catholic Institute of Lille

    Lomme, 59462

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
respiratory rehabilitation using Powerbreathe
Keywords
inspiratory muscles, multiple sclerosis, rehabilitation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • respiratory rehabilitation using PowerbreatheDevice

    10 minutes 2 times a day : 30 inspirations per session during 10 weeks

Study groups in NCT02726672
Study groupRoleWhat they receive
Respiratory rehabilitationExperimentalRespiratory rehabilitation: Powerbreathe training of the inspiratory muscles at home twice a day (2 sessions of 30 inspirations / day) during 10 weeks
Receives: Device: respiratory rehabilitation using Powerbreathe
control groupNo interventionNo respiratory rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 3 months

Secondary outcomes (13)

  1. Sleep disorders graded according to the Epworth Sleepiness Scale

    Measured: 3 months

  2. 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)

    Measured: 3 months

  3. Maximal inspiratory pressure graded according to the Black and Hyatt method

    respiratory manometer according to Black and Hyatt method

    Measured: 3 months

  4. Maximal expiratory pressure graded according to Black and Hyatt method

    respiratory manometer according to Black and Hyatt method

    Measured: 3 months

  5. Forced vital capacity (FVC) graded with a portable spirometer

    Measured: 3 months

  6. Tidal volume graded with a portable spirometer

    Measured: 3 months

  7. Forced expiratory volume in one second (FEV1) graded with a portable spirometer

    Measured: 3 months

  8. FEV1/ FVC ratio graded with a portable spirometer

    Measured: 3 months

  9. Energy consumption during repeated effort

    Metamax 3B

    Measured: 3 months

  10. 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

    Measured: 3 months

  11. Swallowing problems graded according to the DYMUS score

    Measured: 3 months

  12. 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

    Measured: 3 months

  13. Collection of the drug treatments received evaluated by a questionnaire

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMay 2018
  4. Study completionNov 2018

Why it stopped: lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02726672
Sponsor's protocol ID
RC-P0043
Other IDs
2015-A01451-48
Acronym
AIRSEP
Status last verified
Nov 2018
First submitted
22 Mar 2016
Last updated
23 Nov 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing respiratory rehabilitation using Powerbreathe in people with Multiple Sclerosis, run by Lille Catholic University at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue graded according to EMIF-SEP questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02726672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in