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

April 1, 2014 updated by: Rocío Martín Valero, University of Malaga

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain
        • University of Malaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
a 12-week respiratory muscles training program (RMTP) with ORYGEN Dual® device and peripheric resistive muscle training program
Other: a 12-week Respiratory Muscles Training Program (RMTP)
Every session will be lasted 50 minutes and performed under supervision of a physiotherapist. It will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 20 minutes. Patients will be instructed to maintain adequate inspiration and expiration while using the Origen-Dual® valve at a rate of 15-20 breaths/minute. Participants will be performed five sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, once a day, 2 days per week, for 12 weeks. The respiratory muscles training will be begun at 30% of MIP achieved at baseline and increased by 5% each week to reach 60% of the baseline assessment MIP.
Other Names:
  • Intervention Group
Active Comparator: Control Group
Peripheric resistive muscle training program and Health Education Program.
Other: Active Comparator
Every session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)
Time Frame: Baseline and 12 weeks
Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function test
Time Frame: Baseline and 12 weeks
Pulmonary function test will be performed using spirometer "DATOSPIR 120" according to the Guidelines of American Thoracic Society and the European Respiratory Society.
Baseline and 12 weeks
Handgrip strength
Time Frame: Baseline and 12 weeks
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Baseline and 12 weeks
Multiple-Sit-to-Stand Test (MSTS)
Time Frame: Baseline and 12 weeks
Lower limb strength using the Multiple-Sit-to-Stand Test (MSTS)
Baseline and 12 weeks
The 12 item MS Walking Scale (MSWS-12)
Time Frame: Baseline and 12 weeks
Walking Capacity using the 12 item MS Walking Scale (MSWS-12)
Baseline and 12 weeks
Timed 25 foot walk (T25FW)
Time Frame: Baseline and 12 weeks
Exercise Capacity using the Shorter timed walking tests with Timed 25 foot walk (T25FW)
Baseline and 12 weeks
Gait analysis
Time Frame: Baseline and 12 weeks
Gait analysis (the Hauser ambulatory index) with which will be assessed the time and effort used by the patient to walk 25 feet (8 meters)
Baseline and 12 weeks
The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
Time Frame: Baseline and 12 week
Change in quality of life using the 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
Baseline and 12 week
10 Maximum Resistance (10RM)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks.
Change in endurance of the respiratory muscles with the 10RM manoeuvre
Baseline, 4 weeks, 8 weeks, 12 weeks.
Perceptions Measures
Time Frame: 12 weeks
Post interview with participants to qualitatively identify themes of interest and quality of life effects After that the respiratory muscles training program, researchers will interview participants about their interest in carrying out the intervention (difficulties and advantages) and changes in quality of life
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMA_RMTP_2014/SM
  • Respiratory Sclerosis Multple (Other Identifier: RESM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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