Overview

This trial is active, not recruiting.

Condition relapsing-remitting multiple sclerosis
Treatments a 12-week respiratory muscles training program (rmtp), active comparator
Sponsor University of Malaga
Start date March 2014
End date March 2015
Trial size 40 participants
Trial identifier NCT02104492, Respiratory Sclerosis Multple, UMA_RMTP_2014/SM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
a 12-week respiratory muscles training program (RMTP) with ORYGEN Dual® device and peripheric resistive muscle training program
a 12-week respiratory muscles training program (rmtp) Intervention Group
Every session will be lasted 50 minutes and performed under supervision of a physiotherapist. It will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 20 minutes. Patients will be instructed to maintain adequate inspiration and expiration while using the Origen-Dual® valve at a rate of 15-20 breaths/minute. Participants will be performed five sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, once a day, 2 days per week, for 12 weeks. The respiratory muscles training will be begun at 30% of MIP achieved at baseline and increased by 5% each week to reach 60% of the baseline assessment MIP.
(Active Comparator)
Peripheric resistive muscle training program and Health Education Program.
active comparator Control Group
Every session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program.

Primary Outcomes

Measure
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
time frame: Baseline and 12 weeks

Secondary Outcomes

Measure
Pulmonary function test
time frame: Baseline and 12 weeks
Handgrip strength
time frame: Baseline and 12 weeks
Multiple-Sit-to-Stand Test (MSTS)
time frame: Baseline and 12 weeks
The 12 item MS Walking Scale (MSWS-12)
time frame: Baseline and 12 weeks
Timed 25 foot walk (T25FW)
time frame: Baseline and 12 weeks
Gait analysis
time frame: Baseline and 12 weeks
The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
time frame: Baseline and 12 week
10 Maximum Resistance (10RM)
time frame: Baseline, 4 weeks, 8 weeks, 12 weeks.
Perceptions Measures
time frame: 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Research on the Effect of a 12-week Respiratory Muscles Training Program in Persons With Relapsing-remitting Multiple Sclerosis
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by University of Malaga.