Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03887546
Status:
UNKNOWN
Last Update Posted:
2019-03-25
First Post:
2019-01-28
Brief Title:
Inspiratory Muscle Training in Multiple Sclerosis
Sponsor:
University of Salamanca
Organization:
University of Salamanca
Study Overview
Official Title:
Effects of a 12-week Inspiratory Muscle Training Program With Low Resistance in Patients With Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Participants 67 patients with MS distributed in two groups intervention and control
Intervention Intervention group train using IMT for 12 weeks 5 daysweek 15 minutesday 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 daysweek 15 minutesday
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
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 daysweek 15 minutesday 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 daysweek 15 minutesday
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 doesnt 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 101973 cm H2O following the rules of the American thoracic societyEuropean 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 ls and a maximum volume of 10 l The ATSERS 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
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 doesnt 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 101973 cm H2O following the rules of the American thoracic societyEuropean 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 ls and a maximum volume of 10 l The ATSERS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None