Effects of a 12-week Respiratory Muscles Training Program in Persons W

Clinical Research on the Effect of a 12-week Respiratory Muscles Training Program in Persons With Relapsing-remitting Multiple Sclerosis

Status unknownNot a drug-phase studyRelapsing MSNCT02104492

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • a 12-week Respiratory Muscles Training Program (RMTP)

Compared with

  • Active Comparator

What it measured

Main measures

  • Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)

    Baseline and 12 weeks

    Physical functionNerve conduction tests

Other measures (9)

  • Pulmonary function test

    Baseline and 12 weeks

  • Handgrip strength

    Baseline and 12 weeks

    Arm and hand functionPhysical function

  • Multiple-Sit-to-Stand Test (MSTS)

    Baseline and 12 weeks

    Physical function

  • The 12 item MS Walking Scale (MSWS-12)

    Baseline and 12 weeks

    Walking and mobility

  • Timed 25 foot walk (T25FW)

    Baseline and 12 weeks

    Disability progressionWalking and mobilityPhysical function

  • Gait analysis

    Baseline and 12 weeks

    Walking and mobility

  • The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)

    Baseline and 12 week

    Quality of life (reported by participants)

  • 10 Maximum Resistance (10RM)

    Baseline, 4 weeks, 8 weeks, 12 weeks.

    Physical function

  • Perceptions Measures

    12 weeks

    Physical functionQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Mar 2014

      2. Main results due

        Mar 2015

      3. Finished

        Mar 2015

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