Effects of a 12-week Respiratory Muscles Training Program in Persons With Relapsing- Remitting Multiple Sclerosis

Not Applicable

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Other: a 12-week Respiratory Muscles Training Program (RMTP); Other: Active Comparator

• Registration Number: NCT02104492
• Lead Sponsor: University of Malaga

Brief Summary

Multiple sclerosis (MS) is the most common inflammatory demyelinating chronic disease of the central nervous system and the second leading cause of disability in young adults. Motor deficits also involve respiratory muscles. This involvement is present from early stages of disease and is frequently dismissed by professionals until advanced stages of disease. The effect of a training program of respiratory muscles is not sufficiently studied. The aim of this research is to assess the clinical and functional response of a 12-week respiratory muscles training program (RMTP) for persons with relapsing-remitting multiple sclerosis (RRMS).

This study is consisted with two sub research:

Firstly, a single-blind randomized clinical trial will be carried out in 40 persons with RRMS. Participants either will be received (n = 20) peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 50 minutes, twice a week during three months or (n = 20) they will be received peripheric resistive muscle training program and health education program. Main outcomes will be strength of the respiratory muscles assessed by maximal inspiratory and expiratory pressure measurements (MIP and MEP). The secondary outcomes will be assessed the quality of life (MSQOL-54), walking speed (T25-FW, MSWS-12 and Hauser ambulatory index), fatigue (MFIS), endurance of the respiratory muscles (10RM) manoeuvre and peripherical muscle strength (Multiple-Sit-to-Stand Test and handgrip strength).

Secondly, the qualitative research where researchers will interview participants about their interest in carrying out the intervention (difficulties and advantages) and identify themes of interest about changes in quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-27
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-01
• Last Update Submitted: 2014-04-01
• Study First Posted: 2014-04-04
• Last Update Posted: 2014-04-04
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Males and females older 18 years of age with diagnosis relapsing-remitting multiple sclerosis according to revised McDonald Criteria 2005.
• Have mild or moderate impairment of gait according to Hauser ambulatory index. The score 1 and 5 will be included (both values inclusive).
• Subjects who have read, understood, signed and dated the informed consent form.

Exclusion Criteria

• Disability caused by other diseases
• Clinically relevant cognitive or linguistic disorders which are unable to fill in the questionnaires by him/herself
• Subjects used medication with corticosteroids within the last month (or 30 days) prior to study day 1.
• Have a recent outbreak (last month) not stabilized prior to inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	a 12-week Respiratory Muscles Training Program (RMTP)	a 12-week respiratory muscles training program (RMTP) with ORYGEN Dual® device and peripheric resistive muscle training program
Control Group	Active Comparator	Peripheric resistive muscle training program and Health Education Program.

Primary Outcome Measures

Name	Time	Method
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)	Baseline and 12 weeks	Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)

Secondary Outcome Measures

Name	Time	Method
Pulmonary function test	Baseline and 12 weeks	Pulmonary function test will be performed using spirometer "DATOSPIR 120" according to the Guidelines of American Thoracic Society and the European Respiratory Society.
Gait analysis	Baseline and 12 weeks	Gait analysis (the Hauser ambulatory index) with which will be assessed the time and effort used by the patient to walk 25 feet (8 meters)
The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)	Baseline and 12 week	Change in quality of life using the 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
10 Maximum Resistance (10RM)	Baseline, 4 weeks, 8 weeks, 12 weeks.	Change in endurance of the respiratory muscles with the 10RM manoeuvre
Perceptions Measures	12 weeks	Post interview with participants to qualitatively identify themes of interest and quality of life effects After that the respiratory muscles training program, researchers will interview participants about their interest in carrying out the intervention (difficulties and advantages) and changes in quality of life
Handgrip strength	Baseline and 12 weeks	Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Multiple-Sit-to-Stand Test (MSTS)	Baseline and 12 weeks	Lower limb strength using the Multiple-Sit-to-Stand Test (MSTS)
The 12 item MS Walking Scale (MSWS-12)	Baseline and 12 weeks	Walking Capacity using the 12 item MS Walking Scale (MSWS-12)
Timed 25 foot walk (T25FW)	Baseline and 12 weeks	Exercise Capacity using the Shorter timed walking tests with Timed 25 foot walk (T25FW)

Trial Locations

Locations (1)

University of Málaga; 🇪🇸 Málaga, Spain