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

NCT02104492 | Unknown DMC

• 2 other identifiers: UMA_RMTP_2014/SMRespiratory Sclerosis Multple
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Pulmonary function test

  Baseline and 12 weeks

• Handgrip strength

  Baseline and 12 weeks

• Multiple-Sit-to-Stand Test (MSTS)

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Timed 25 foot walk (T25FW)

  Baseline and 12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

Peripheric resistive muscle training program and Health Education Program.

Other: Active Comparator

Interventions

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

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.

Also known as: Intervention Group

Intervention group

Active Comparator OTHER

Every session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program.

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

University of Málaga

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 4, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

ES (1)