Relapsing-remitting Multiple Sclerosis Clinical Trial
Official title:
Clinical Research on the Effect 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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