Fatigue and Inspiratory Muscles Training in Patients With Multiple Sclerosis

NCT02726672 | Terminated

• 2 other identifiers: RC-P00432015-A01451-48
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

inspiratory muscles; multiple sclerosis; rehabilitation

Outcome Measures

Primary Outcomes (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)

  3 months

Secondary Outcomes (13)

• Sleep disorders graded according to the Epworth Sleepiness Scale

  3 months

• Quality of life graded according to the SEP-59 questionnaire

  3 months

• Maximal inspiratory pressure graded according to the Black and Hyatt method

  3 months

• Maximal expiratory pressure graded according to Black and Hyatt method

  3 months

• Forced vital capacity (FVC) graded with a portable spirometer

  3 months

Study Arms (2)

Respiratory rehabilitation

EXPERIMENTAL

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

control group

NO INTERVENTION

No respiratory rehabilitation

Interventions

respiratory rehabilitation using Powerbreathe DEVICE

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

Respiratory rehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hospital Group of the Catholic Institute of Lille

Lomme, 59462, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Cécile Donzé, MD

  Hospital Group of the Catholic Institute of Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 4, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)