Relapsing-remitting Multiple SclerosisNCT02104492
Effects of a 12-week Respiratory Muscles Training Program in Persons With Relapsing- Remitting Multiple Sclerosis
A study testing a 12-week Respiratory Muscles Training Program (RMTP) and Active Comparator in people with Relapsing-remitting Multiple Sclerosis, run by University of Malaga at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- a 12-week Respiratory Muscles Training Program (RMTP) and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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
- Being tested
- a 12-week Respiratory Muscles Training Program (RMTP), Active Comparator
- Keywords
- multiple sclerosis, respiratory muscle strength, maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), respiratory muscle endurance, quality of life, qualitative research
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a 12-week Respiratory Muscles Training Program (RMTP)Other
Also called Intervention Group
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 ComparatorOther
Also called Control Group
Every session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | a 12-week respiratory muscles training program (RMTP) with ORYGEN Dual® device and peripheric resistive muscle training program Receives: Other: a 12-week Respiratory Muscles Training Program (RMTP) |
| Control Group | Active comparator | Peripheric resistive muscle training program and Health Education Program. Receives: Other: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 12 weeks
Secondary outcomes (9)
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.
Measured: Baseline and 12 weeks
Handgrip strength
Handgrip strength will be determined using hydraulic hand dynamometer "JAMAR"
Measured: Baseline and 12 weeks
Multiple-Sit-to-Stand Test (MSTS)
Lower limb strength using the Multiple-Sit-to-Stand Test (MSTS)
Measured: Baseline and 12 weeks
The 12 item MS Walking Scale (MSWS-12)
Walking Capacity using the 12 item MS Walking Scale (MSWS-12)
Measured: Baseline and 12 weeks
Timed 25 foot walk (T25FW)
Exercise Capacity using the Shorter timed walking tests with Timed 25 foot walk (T25FW)
Measured: Baseline and 12 weeks
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)
Measured: Baseline and 12 weeks
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)
Measured: Baseline and 12 week
10 Maximum Resistance (10RM)
Change in endurance of the respiratory muscles with the 10RM manoeuvre
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104492
- Sponsor's protocol ID
- UMA_RMTP_2014/SM
- Other IDs
- Respiratory Sclerosis Multple
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Effect of a 12-week Respiratory Muscles Training Program in Persons With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02104492
- Acronym / sponsor ID
- UMA_RMTP_2014/SM
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: a 12-week Respiratory Muscles Training Program (RMTP)a 12-week respiratory muscles training program (RMTP) with ORYGEN Dual® device and peripheric resistive muscle training program |
| Control Group | Active comparator | Other: Active ComparatorPeripheric resistive muscle training program and Health Education Program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a 12-week Respiratory Muscles Training Program (RMTP)Also: Intervention GroupEvery 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 | Intervention group |
| Active ComparatorAlso: Control GroupEvery session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program. | Other | Control Group |
Primary outcome
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)
9 secondary outcomes
Pulmonary function test
Time frame: Baseline and 12 weeks
Handgrip strength
Time frame: Baseline and 12 weeks
Multiple-Sit-to-Stand Test (MSTS)
Time frame: Baseline and 12 weeks
The 12 item MS Walking Scale (MSWS-12)
Time frame: Baseline and 12 weeks
Timed 25 foot walk (T25FW)
Time frame: Baseline and 12 weeks
Gait analysis
Time frame: Baseline and 12 weeks
The 54 items Specific Questionnaire Quality of Life Multiple Sclerosis (MSQOL-54)
Time frame: Baseline and 12 week
10 Maximum Resistance (10RM)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks.
Perceptions Measures
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a 12-week Respiratory Muscles Training Program (RMTP) and Active Comparator in people with Relapsing-remitting Multiple Sclerosis, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.