Multiple SclerosisNCT03887546
Inspiratory Muscle Training in Multiple Sclerosis
A study testing Inspiratory muscle trainer and Respiratory exercise in people with Multiple Sclerosis, run by University of Salamanca.
Trial summary
Objective: To evaluate the effectiveness of a low-intensity protocol of inspiratory muscle training (IMT) to improve respiratory strength, spirometric parameters and dyspnea in patients with multiple sclerosis (MS). Design: Clinical trial. Randomized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Inspiratory muscle trainer and Respiratory exercise
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 23 Apr 2019to 15 Sep 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with MS
- Over 18 years old
- Disability lower than 9 in the EDSS
- Be able to understand the objectives of the study
Who cannot join
- Participants with a current or past neurological pathology other than MS
- Relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study
- Any other complication that may impede the performance of the evaluation tests or breathing techniques
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of a 12-week Inspiratory Muscle Training Program With Low Resistance in Patients With Multiple Sclerosis
Objective: To evaluate the effectiveness of a low-intensity protocol of inspiratory muscle training (IMT) to improve respiratory strength, spirometric parameters and dyspnea in patients with multiple sclerosis (MS).
Design: Clinical trial. Randomized. Participants: 67 patients with MS, distributed in two groups, intervention and control.
Read more
Intervention: Intervention group train using IMT for 12 weeks, 5 days/week, 15 minutes/day (20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week). Control group follow a respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.
Evaluations: Determination of the MIP and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); dyspnea using the Borg scale and clinical evaluations.
Read the detailed description
Participants:
Patients from two MS associations will be recruited to participate in a 12-week randomized trial.
The sample size calculation determine that 31 participants in each group are required to observe a minimum difference in the maximum inspiratory pressure (MIP) of 12 cm H2O, considering a power of 90%, a safety of 95% and a 10% dropout rate.
The participants in the study are diagnosed with MS, are over 18 years old, have a disability lower than 9 in the Expanded disability status scale (EDSS) and are able to understand the objectives of the study. Those participants with a current or past neurological pathology other than MS will be excluded from the study, as well as those who had had a relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study, or any other complication that may have impeded the performance of the evaluation tests or breathing techniques. All patients will be asked to carry out the 5-day weekly program at home, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out. The intervention group (n = 36) will receive a training protocol of IMT, while the control group (n = 31) will follow a program of nasal breathing and maximum exhalations.
Evaluation:
The participants are evaluated at the beginning and end of the intervention period.
The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which obtains each measurement in millibar and converts it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic society/European respiratory society (ATS / ERS) [19]. The procedure will be repeated until 3 values were obtained with a difference of less than 5%, and the highest value will be used for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the IMT workload.
Lung volumes are assessed using a datospir touch spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will be followed [19], and the highest value of three correct measurements will be chosen. Data is collected for the following parameters: maximum voluntary ventilation (MVV), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).
Dyspnea will be measured using the modified Borg scale [20]. All evaluations will be done in the corresponding center, during the same time slot and by the same examiner for both groups.
Intervention:
For the intervention group, a protocol different from those referred to in the literature has been designed to cover the respiratory deficiencies of MS patients using IMT. The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O). During the first two weeks a MIP load of 20% will be used, followed by a load of 30% for the rest of the training period. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
The training program of the control group involves nasal inhalations and maximum exhalations. The following types of breathing exercises will be carried out for 3 minutes each with a 1 minute pause for resting: abdominal breathing, chest breathing, breathing and shoulder flexion, shoulder breathing and abduction, breathing and shoulder abduction in the transverse plane. The complete protocol involves 30 minutes of daily respiratory training.
- Conditions
- Multiple Sclerosis
- Being tested
- Inspiratory muscle trainer, Respiratory exercise
- Keywords
- Multiple sclerosis, Rehabilitation, Respiration, Breathing exercise, Fatigue
- Medical subject headings
- Multiple Sclerosis, Respiratory Aspiration, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainerDevice
The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
Respiratory exerciseProcedure or surgery
Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention is administrated with Inspiratory Muscle Trainer. 20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week.
12 weeks, 5 days/week, 15 minutes/day. Receives: Device: Inspiratory muscle trainer |
| Control group | Active comparator | Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day Receives: Procedure: Respiratory exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the ATS / ERS. The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
Measured: 5 minutes
Maximal expiratory pressure (MEP)
The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase. Measure: cm H20
Measured: 5 minutes
Secondary outcomes (8)
Dyspnea
Dyspnea is assessed using modified Borg scale. It is a scale between 1-10 points, 1 is the minimum and 10 is the maximum level of dyspnea or fatigue. More punctuation in the scale, more dyspnea.
Measured: 1 minute
Maximum voluntary ventilation (MVV)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: Liter(L) / minute(m)
Measured: 1 minute
Forced expiratory volume in the first second (FEV1)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
Measured: 1 minute
Peak expiratory flow (PEF)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L / second (s)
Measured: 1 minute
Mean expiratory flow (FEF25-75)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L / s
Measured: 1 minute
Vital capacity (VC)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
Measured: 1 minute
Tidal volume (VT)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
Measured: 1 minute
Forced vital capacity (FVC)
Spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules were followed [19], and the highest value of three correct measurements was chosen. Measure: L
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start23 Apr 2019 (estimated)
- Primary completion24 Jul 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Patients are assigned randomly to the two working groups, each patient only receives one of the two protocols.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARLOS MARTIN SANCHEZ, University of Salamanca
- Investigators
- ANA MARIA MARTIN-NOGUERAS, DR, Study chair, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887546
- Sponsor's protocol ID
- 24121989
- Status last verified
- Mar 2019
- First submitted
- 28 Jan 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Inspiratory Muscle Training Program With Low Resistance in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03887546
- Acronym / sponsor ID
- 24121989
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Rehabilitation, Respiration, Breathing exercise, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 23 Apr 2019 (estimated)
- Primary completion
- 24 Jul 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 25 Mar 2019 (actual)
- 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.
Objective: To evaluate the effectiveness of a low-intensity protocol of inspiratory muscle training (IMT) to improve respiratory strength, spirometric parameters and dyspnea in patients with multiple sclerosis (MS).
Design: Clinical trial. Randomized. Participants: 67 patients with MS, distributed in two groups, intervention and control.
Intervention: Intervention group train using IMT for 12 weeks, 5 days/week, 15 minutes/day (20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week). Control group follow a respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.
Evaluations: Determination of the MIP and the maximum expiratory pressure (MEP); spirometry - maximum voluntary ventilation (MVV), peak expiratory flow (PEF), tidal volume (TV); dyspnea using the Borg scale and clinical evaluations.
Detailed description
Participants:
Patients from two MS associations will be recruited to participate in a 12-week randomized trial.
The sample size calculation determine that 31 participants in each group are required to observe a minimum difference in the maximum inspiratory pressure (MIP) of 12 cm H2O, considering a power of 90%, a safety of 95% and a 10% dropout rate.
The participants in the study are diagnosed with MS, are over 18 years old, have a disability lower than 9 in the Expanded disability status scale (EDSS) and are able to understand the objectives of the study. Those participants with a current or past neurological pathology other than MS will be excluded from the study, as well as those who had had a relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study, or any other complication that may have impeded the performance of the evaluation tests or breathing techniques. All patients will be asked to carry out the 5-day weekly program at home, and a recording sheet will be provided to each participant so they will can record the time of each daily respiratory training session. All participants signed an informed consent form.
The patients will be assigned to the two groups randomly. The main researcher doesn´t meet any of the participants until the initial assessment will be carried out. The intervention group (n = 36) will receive a training protocol of IMT, while the control group (n = 31) will follow a program of nasal breathing and maximum exhalations.
Evaluation:
The participants are evaluated at the beginning and end of the intervention period.
The evaluation of MIP and MEP is performed using a pressure transducer, Elka 15, which obtains each measurement in millibar and converts it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O .), following the rules of the American thoracic society/European respiratory society (ATS / ERS) [19]. The procedure will be repeated until 3 values were obtained with a difference of less than 5%, and the highest value will be used for the analysis. The MIP of the intervention group will be assessed every 2 weeks to set the IMT workload.
Lung volumes are assessed using a datospir touch spirometer with a turbine transducer with a maximum flow of 16 l/s and a maximum volume of 10 l. The ATS/ERS rules will be followed [19], and the highest value of three correct measurements will be chosen. Data is collected for the following parameters: maximum voluntary ventilation (MVV), forced expiratory volume in the first second (FEV1), peak expiratory flow (PEF), mean expiratory flow (FEF25-75), vital capacity (VC), tidal volume (TV) and forced vital capacity (FVC).
Dyspnea will be measured using the modified Borg scale [20]. All evaluations will be done in the corresponding center, during the same time slot and by the same examiner for both groups.
Intervention:
For the intervention group, a protocol different from those referred to in the literature has been designed to cover the respiratory deficiencies of MS patients using IMT. The device incorporates a unidirectional valve independent of flow to guarantee constant resistance and includes a specific pressure setting (in cm H2O). During the first two weeks a MIP load of 20% will be used, followed by a load of 30% for the rest of the training period. The protocol includes 15 cycles lasting 1 minute, twice a day: one in the morning and one in the afternoon. The participants rest for 1 minute between each cycle. In total, the protocol includes 30 minutes of daily respiratory training. The patients will be instructed to inhale with enough force to reach the opening of the valve.
The training program of the control group involves nasal inhalations and maximum exhalations. The following types of breathing exercises will be carried out for 3 minutes each with a 1 minute pause for resting: abdominal breathing, chest breathing, breathing and shoulder flexion, shoulder breathing and abduction, breathing and shoulder abduction in the transverse plane. The complete protocol involves 30 minutes of daily respiratory training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients are assigned randomly to the two working groups, each patient only receives one of the two protocols.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Inspiratory muscle trainerIntervention is administrated with Inspiratory Muscle Trainer. 20% maximum inspiratory pressure (MIP) during the first two weeks and 30% MIP after the second week. 12 weeks, 5 days/week, 15 minutes/day. |
| Control group | Active comparator | Procedure: Respiratory exerciseRespiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with MS
- Over 18 years old
- Disability lower than 9 in the EDSS
- Be able to understand the objectives of the study
Key exclusion criteria (3 listed)
- Participants with a current or past neurological pathology other than MS
- Relapse of MS or any respiratory pathology during the 4 weeks prior to the start of the study
- Any other complication that may impede the performance of the evaluation tests or breathing techniques
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 |
|---|---|---|
| Inspiratory muscle trainerThe device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O). | Device | Intervention group |
| Respiratory exerciseRespiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day. | Procedure or surgery | Control group |
Primary outcome
Maximal inspiratory pressure (MIP)
Time frame: 5 minutes
The evaluation is performed using a pressure transducer, Elka 15, which obtainer each measurement in millibar and converted it into the reference unit of centimeter of water (cm H2O) (1 mbar = 1.01973 cm H2O), following the rules of the ATS / ERS. The procedure was repeated until 3 values were obtained with a difference of less than 5%, and the highest value was used for the analysis. The MIP of the intervention group was assessed every 2 weeks to set the IMT workload.
Maximal expiratory pressure (MEP)
Time frame: 5 minutes
The evaluation is performed using a pressure transducer, Elka 15. It is evaluated at the beginning and at the end of the interventional phase. Measure: cm H20
8 secondary outcomes
Dyspnea
Time frame: 1 minute
Maximum voluntary ventilation (MVV)
Time frame: 1 minute
Forced expiratory volume in the first second (FEV1)
Time frame: 1 minute
Peak expiratory flow (PEF)
Time frame: 1 minute
Mean expiratory flow (FEF25-75)
Time frame: 1 minute
Vital capacity (VC)
Time frame: 1 minute
Tidal volume (VT)
Time frame: 1 minute
Forced vital capacity (FVC)
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: No
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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.
ANA MARIA MARTIN-NOGUERAS, DR study chair
University of Salamanca
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle trainer and Respiratory exercise in people with Multiple Sclerosis, run by University of Salamanca.
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 4 inclusion and 3 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact CARLOS MARTIN SANCHEZ, DOCTOR (+34646774655, carlos_ms@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 25 Mar 2019.