Inspiratory Muscle Training in Individuals With Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University - Cerrahpasa
About this trial
Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, characterized by inflammation, demyelination, and axonal degeneration, and primarily affects young adults. Muscle weakness, sensory disturbances, spasticity, pain, visual impairment, ataxia, fatigue, cognitive dysfunction, and respiratory complications are among the most commonly reported symptoms in individuals with MS. Although inspiratory muscle training has been shown to have beneficial effects in individuals with MS, the effects of different inspiratory muscle training intensities on respiratory muscle strength and pulmonary function have not been sufficiently investigated.
The primary aim of this study is to investigate the effectiveness and clinical feasibility of high-intensity interval inspiratory muscle training in individuals with MS. The secondary aim is to compare the effects of high-intensity interval inspiratory muscle training, low-intensity inspiratory muscle training, and conventional rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life in individuals with MS.
Participants will be randomly assigned to one of three groups: a high-intensity interval inspiratory muscle training group, a low-intensity inspiratory muscle training group, or a conventional rehabilitation group. All three groups will receive conventional rehabilitation, while the inspiratory muscle training groups will additionally receive their respective inspiratory muscle training programs. This study aims to be the first randomized controlled trial to evaluate the effects of high-intensity interval inspiratory muscle training in individuals with MS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of multiple sclerosis (MS) according to the 2024 McDonald criteria
Expanded Disability Status Scale (EDSS) score ≥2 and <6
Age between 18 and 65 years
Mini-Mental State Examination (MMSE) score >24
Disqualifiers
Experiencing an MS relapse within the past three months
Presence of chronic cardiac or pulmonary diseases that may affect respiratory muscle strength and function, such as COPD, asthma, interstitial lung disease, or heart failure
Presence of pulmonary infection
Presence of orthopedic problems
Trial design
Design model
Parallel
Treatments tested in this trial
High intensity interval IMT
BehavioralParticipants with multiple sclerosis (MS) in this group will perform high intensity interval inspiratory muscle training (IMT) for 8 weeks, three times per week (one supervised by a physiotherapist and two home-based sessions). The protocol consists of 7 cycles of 2 minutes of exercise followed by 1 minute of rest, with each session lasting 21 minutes. Training intensity will start at 30% of maximal inspiratory pressure (MIP) and progressively increase to 70% by the third week. From week 4 onward, intensity will be maintained at 70% of MIP and adjusted according to tolerance, based on a Borg scale rating of 3-5. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.
Low intensity IMT
BehavioralParticipants with multiple sclerosis (MS) in this group will perform low intensity inspiratory muscle training (IMT) for 8 weeks, consisting of five sessions per week: one supervised by a physiotherapist and four home-based supervised sessions. The training will be performed as two daily sessions of 15 minutes each, totaling 30 minutes per day. Low intensity IMT will be conducted at 30% of maximal inspiratory pressure (MIP). Training intensity will be reassessed and adjusted to 30% of MIP every two weeks during supervised sessions, based on repeated MIP measurements. During training, participants will be instructed to maintain a seated position with the upper chest and shoulders in a relaxed posture. In addition, participants in this group will receive a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised session conducted by a physiotherapist and two supervised home-based sessions.
Conventional rehabilitation
BehavioralParticipants in this group will undergo a conventional rehabilitation program for 8 weeks, consisting of three sessions per week: one supervised by a physiotherapist and two home-based supervised sessions. Each session will last approximately 40 minutes. The program will include warm-up exercises, aerobic exercises, strengthening exercises, balance exercises, and cool-down exercises.
Treatment groups
48 Participants
are divided into 3 treatment groupsGroup A: High intensity interval IMT groupExperimental treatment 1 intervention
Group B: Low intensity IMT groupExperimental treatment 1 intervention
Group C: Conventional rehabilitationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximal inspiratory pressure (MIP)
In our study, respiratory muscle strength will be assessed using an electronic mouth pressure measurement device (MicroRPM Respiratory Pressure Meter). For maximal inspiratory pressure (MIP) measurement, participants will be asked to wear a nose clip and perform a maximal inspiratory effort lasting at least 1.5 seconds through a mouthpiece after maximal expiration. Measurements will be performed in a seated position with rest intervals between attempts. The highest value obtained from three consecutive trials will be recorded in cmH₂O. The best value will also be expressed as a percentage of predicted normal values according to age and sex.
Time frame
From baseline to the end of the intervention at 8 weeks2
Maximal expiratory pressure (MEP)
In our study, respiratory muscle strength will be assessed using an electronic mouth pressure measurement device (MicroRPM Respiratory Pressure Meter). For maximal expiratory pressure (MEP) measurement, participants will be asked to wear a nose clip and perform a maximal expiratory effort lasting at least 1.5 seconds through a mouthpiece after maximal inspiration. Measurements will be performed in a seated position with rest intervals between attempts. The highest value obtained from three consecutive trials will be recorded in cmH₂O. The best value will also be expressed as a percentage of predicted normal values according to age and sex.
Time frame
From baseline to the end of the intervention at 8 weeks3
Forced Vital Capacity (FVC)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Time frame
From baseline to the end of the intervention at 8 weeks4
Forced Expiratory Volume (FEV1)
The pulmonary function test will be performed using the COSMED Pony FX device in accordance with the American Thoracic Society and European Respiratory Society guidelines.
Time frame
From baseline to the end of the intervention at 8 weeksSecondary outcomes
1
Exercise capacity
Functional capacity is assessed using the 6-Minute Walk Test according to the criteria of the American Thoracic Society. Participants are instructed to walk as fast as possible, but without running, at their own pace along a 30-meter flat corridor for 6 minutes. The distance covered is recorded in meters.
Time frame
From baseline to the end of the intervention at 8 weeks2
Lower Extremity Functional Capacity
Lower extremity functional capacity will be assessed using the Five Times Sit-to-Stand Test. Participants will be seated in a chair without armrests, with their arms crossed over the chest, and will be instructed to stand up and sit down five times as quickly as possible. The time required to complete the test will be recorded.
Time frame
From baseline to the end of the intervention at 8 weeks3
Balance
Balance will be assessed using the Mini-BESTest. The Mini-BESTest is a 14-item short version of the Balance Evaluation Systems Test (BESTest) designed to assess static and dynamic balance impairments and underlying postural control mechanisms. It includes four domains: anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0 to 2, with a total score ranging from 0 to 28, where higher scores indicate better balance performance.
Time frame
From baseline to the end of the intervention at 8 weeks4
Balance
Balance will be assessed using the Activities-specific Balance Confidence (ABC) Scale. The ABC Scale will be used to assess balance confidence during daily activities. Participants will rate their confidence in performing 16 different activities on a scale from 0% (no confidence) to 100% (complete confidence). The total score is calculated by averaging item scores, with higher scores indicating lower fear of falling.
Time frame
From baseline to the end of the intervention at 8 weeksLocations
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Source ClinicalTrials.gov
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