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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02104492
• Other study ID #: UMA_RMTP_2014/SM
• Secondary ID: Respiratory Scle
• Status: Active, not recruiting
• Phase: N/A
• First received: March 27, 2014
• Last updated: April 1, 2014
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2014
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	University of Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP)	Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)	Baseline and 12 weeks	No
Secondary	Pulmonary function test	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	No
Secondary	Handgrip strength	Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"	Baseline and 12 weeks	No
Secondary	Multiple-Sit-to-Stand Test (MSTS)	Lower limb strength using the Multiple-Sit-to-Stand Test (MSTS)	Baseline and 12 weeks	No
Secondary	The 12 item MS Walking Scale (MSWS-12)	Walking Capacity using the 12 item MS Walking Scale (MSWS-12)	Baseline and 12 weeks	No
Secondary	Timed 25 foot walk (T25FW)	Exercise Capacity using the Shorter timed walking tests with Timed 25 foot walk (T25FW)	Baseline and 12 weeks	No
Secondary	Gait analysis	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	No
Secondary	The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)	Change in quality of life using the 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)	Baseline and 12 week	No
Secondary	10 Maximum Resistance (10RM)	Change in endurance of the respiratory muscles with the 10RM manoeuvre	Baseline, 4 weeks, 8 weeks, 12 weeks.	No
Secondary	Perceptions Measures	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	No