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

University of Malaga

Status

Unknown

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Other: a 12-week Respiratory Muscles Training Program (RMTP)

Other: Active Comparator

Study type

Interventional

Funder types

Other

Identifiers

NCT02104492

UMA_RMTP_2014/SM

Respiratory Sclerosis Multple (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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