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