Clinical trial NCT02104492: Effects of a 12-week Respiratory Muscles Training Program in Persons With Relapsing- Remitting Multiple Sclerosis
Official title: Clinical Research on the Effect of a 12-week Respiratory Muscles Training Program in Persons With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: multiple sclerosis
respiratory muscle strength
maximal inspiratory pressure (MIP)
maximal expiratory pressure (MEP)
respiratory muscle endurance
quality of life
qualitative research
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Pulmonary function test
timeFrame: Baseline and 12 weeks
measure: Handgrip strength
timeFrame: Baseline and 12 weeks
measure: Multiple-Sit-to-Stand Test (MSTS)
timeFrame: Baseline and 12 weeks
measure: The 12 item MS Walking Scale (MSWS-12)
timeFrame: Baseline and 12 weeks
measure: Timed 25 foot walk (T25FW)
timeFrame: Baseline and 12 weeks
measure: Gait analysis
timeFrame: Baseline and 12 weeks
measure: The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
timeFrame: Baseline and 12 week
measure: 10 Maximum Resistance (10RM)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks.
measure: Perceptions Measures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
References: