Multiple SclerosisNCT06075472
The Effect of Inspiratory Muscle Training on Balance and Postural Control in Multiple Sclerosis Patients
A study testing Inspiratory Muscle Training and Balance Exercises in people with Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to investigate the effect of inspiratory muscle training (IMT) in Multiple Sclerosis (MS) patients on balance and postural control. The main question it aims to answer are: Is IMT effective in improving balance and postural control in MS patients? Participants will be randomly divided into… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Inspiratory Muscle Training and Balance Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2023to 26 Jun 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of relapsing-remitting MS with an EDSS of 1.5-5.5
- Having a Mini Mental Test score greater than 24
- Being between the ages of 18-65
Who cannot join
- Having a neurological disease other than MS
- Having an attack while working
- Problems other than MS that may affect balance
- Have a diagnosis of cardiac or pulmonary disease that will affect breathing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Şişli
About this study
The goal of this study is to investigate the effect of inspiratory muscle training (IMT) in Multiple Sclerosis (MS) patients on balance and postural control. The main question it aims to answer are:
- Is IMT effective in improving balance and postural control in MS patients? Participants will be randomly divided into two groups. One group will be given only balance exercises. The other group will be given IMT treatment in addition to balance exercises.
Read the detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS). MS is a disease that usually progresses with attacks and can lead to progressive disability and severely restrict the quality of life in patients due to the accumulation of sequelae after attacks or the development of a progressive degenerative process. Somatosensory findings, motor findings, postural control-balance and coordination disorders, bladder-intestinal problems, visual, cognitive and psychiatric findings, fatigue and sleep disorders are seen in patients related to the CNS involvement site.
Balance, one of the International Classification of Functioning headings, is a skill included in activity and participation, expressing the body's ability to maintain its upright position against gravity, and reflects stability limits. Balance impairment is one of the most common problems in patients with MS and is one of the factors that cause disability. Lesions in the brain stem and cerebellum cause loss of postural control and balance. There are many causes of loss of balance: visual symptoms, optic neuritis, vestibular changes, somatosensory changes, ventromedial tract lesion, tone changes, loss of muscle strength, incoordination.
Respiratory dysfunction in individuals with MS is an important problem that starts from the early period of the disease, increases in severity with the progression of the disability and causes mortality. Considering the pathophysiology of respiratory problems in MS, unlike other neuromuscular diseases, demyelinating lesions are found and spread in one or more areas related to breathing in the brain and spinal cord. The location and size of the plaques were associated with muscle weakness.
One of the methods used in the field of pulmonary rehabilitation in MS patients is Inspiratory Muscle Training (IMT). The muscles responsible for primary inspiration are the diaphragm, external intercostal muscles, and scalene muscles. Inspiratory muscle training increases inspiratory muscle strength, type 1 muscle fibers, reduces dyspnea, increases maximum minute ventilation and 6-minute walking distance and quality of life. It is usually applied at 30% of the maximal inspiratory pressure (MIP) value for 30 minutes a day.
The effect of the core muscles is great in providing balance and postural control. The diaphragm forms the roof of the core muscles and plays an important role in the mobility of the thorax. Training the diaphragm muscle, like other muscles, is important for maintaining dynamic and static balance. IMT can help stabilize thoracic mobility by strengthening the diaphragm and scalene muscles, contributing to the stability of chest movements and improving transfer skills.
- Conditions
- Multiple Sclerosis
- Being tested
- Inspiratory Muscle Training, Balance Exercises
- Keywords
- balance, inspiratory muscle training, postural control
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training (IMT) is a therapeutic technique which involves specific training of respiratory muscles to yield improvements in inspiratory muscle strength and respiratory function.
Balance ExercisesOther
Balance exercises involve functional movements at the individual's maximum level of independence.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | IMT: Inspiratory Muscle Training. Five days per week, 30 minutes per day. Receives: Other: Inspiratory Muscle Training; Other: Balance Exercises |
| Control Group | Active comparator | Balance exercises: It has been specially designed for the patient. Receives: Other: Balance Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-BesTEST
Mini-BESTest consists of 14 items divided into four subsections. In the Mini-BESTest evaluation, each item receives a three-point score.
rated on an ordinal scale (0= lowest function ranging from level to 2= Normal function level). The total score is the sum of the scores obtained from these items. and ranges from 0 (worst) to 28 (best).
Measured: Fifteen minutes
Trunk Impact Scale
The Trunk Impact Scale (TIS) consists of three subscales: static sitting balance, dynamic sitting balance and co-ordination. Each subscale contains between three and ten items. The TIS score ranges from a minimum of 0 to a maximum of 23.
Measured: Ten minutes
Secondary outcomes (5)
Falls Efficacy Scale International
The Falls Efficacy Scale-International (FES-I) is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned).
Measured: Fifteen Minutes
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
The Multiple Sclerosis Quality of Life-54 (MSQOL-54) was developed by using the RAND 36-item Health Survey 1.0 (SF-36) as a generic core measure, to enable comparisons of health-related quality of life (HRQOL) of patients with multiple sclerosis to those of other patient populations and to the general population.
To enhance comparisons within groups of multiple sclerosis patients, these items were supplemented with 16 additional items in the areas of health distress, sexual function, satisfaction with sexual function, overall quality of life, cognitive function, energy, pain, and social function.
The final measure, the MSQOL-54 Instrument, contains 54 items.
Measured: Twenty minutes
Activities-Specific Balance Confidence Scale
The Activities-Specific Balance Confidence (ABC) Scale is a patient-reported outcome measure that asks individuals to rate how confident they are that they will not lose their balance while performing 16 different activities.
The ABC Activities range from common tasks like walking around the house to less common and more challenging situations, like stepping off of a moving escalator while carrying packages. The patient is asked to rate their confidence in their balance, while performing 16 activities, on a percentage scale of 0 to 100, where 0 is a certainty of falling or becoming unstable and 100 is complete confidence in the patient's own ability to stay balanced.
Measured: Ten Minutes
Two minutes walking test
The Two/2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
Measured: Four minutes
Pulmonary Function Test
Pulmonary function tests (PFTs) allow health proffessionals to evaluate the respiratory function of their patients in many clinical situations and when there are risk factors for lung disease, occupational exposures, and pulmonary toxicity.
Measured: Ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start6 Mar 2023
- Primary completion26 Feb 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Duman Özkan, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075472
- Sponsor's protocol ID
- MarmaraU_DumanOzkan_01
- Status last verified
- May 2025
- First submitted
- 29 Dec 2022
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers.
Publications
Martin-Sanchez C, Calvo-Arenillas JI, Barbero-Iglesias FJ, Fonseca E, Sanchez-Santos JM, Martin-Nogueras AM. Effects of 12-week inspiratory muscle training with low resistance in patients with multiple sclerosis: A non-randomised, double-blind, controlled trial. Mult Scler Relat Disord. 2020 Nov;46:102574. doi: 10.1016/j.msard.2020.102574. Epub 2020 Oct 8.
PubMed 33296972Huang MH, Fry D, Doyle L, Burnham A, Houston N, Shea K, Smith H, Wiske L, Goode J, Khitrik E, Kolanda M. Effects of inspiratory muscle training in advanced multiple sclerosis. Mult Scler Relat Disord. 2020 Jan;37:101492. doi: 10.1016/j.msard.2019.101492. Epub 2019 Nov 1.
PubMed 31707233Inzelberg R, Peleg N, Nisipeanu P, Magadle R, Carasso RL, Weiner P. Inspiratory muscle training and the perception of dyspnea in Parkinson's disease. Can J Neurol Sci. 2005 May;32(2):213-7. doi: 10.1017/s0317167100003991.
PubMed 16018157Duman Ozkan T, Oguz S, Unal E, Emir C, Polat MG. Effects of inspiratory muscle training on balance, trunk control, fear of falling, respiratory function, and quality of life in people with multiple sclerosis: a randomized controlled trial. Mult Scler Relat Disord. 2025 Nov;103:106699. doi: 10.1016/j.msard.2025.106699. Epub 2025 Aug 18.
PubMed 40848620
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Balance and Postural Control in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06075472
- Acronym / sponsor ID
- MarmaraU_DumanOzkan_01
- Conditions
- Multiple Sclerosis
- Keywords
- balance, inspiratory muscle training, postural control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 10 Oct 2023 (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.
The goal of this study is to investigate the effect of inspiratory muscle training (IMT) in Multiple Sclerosis (MS) patients on balance and postural control. The main question it aims to answer are:
- Is IMT effective in improving balance and postural control in MS patients? Participants will be randomly divided into two groups. One group will be given only balance exercises. The other group will be given IMT treatment in addition to balance exercises.
Detailed description
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and neurodegenerative disease of the central nervous system (CNS). MS is a disease that usually progresses with attacks and can lead to progressive disability and severely restrict the quality of life in patients due to the accumulation of sequelae after attacks or the development of a progressive degenerative process. Somatosensory findings, motor findings, postural control-balance and coordination disorders, bladder-intestinal problems, visual, cognitive and psychiatric findings, fatigue and sleep disorders are seen in patients related to the CNS involvement site.
Balance, one of the International Classification of Functioning headings, is a skill included in activity and participation, expressing the body's ability to maintain its upright position against gravity, and reflects stability limits. Balance impairment is one of the most common problems in patients with MS and is one of the factors that cause disability. Lesions in the brain stem and cerebellum cause loss of postural control and balance. There are many causes of loss of balance: visual symptoms, optic neuritis, vestibular changes, somatosensory changes, ventromedial tract lesion, tone changes, loss of muscle strength, incoordination.
Respiratory dysfunction in individuals with MS is an important problem that starts from the early period of the disease, increases in severity with the progression of the disability and causes mortality. Considering the pathophysiology of respiratory problems in MS, unlike other neuromuscular diseases, demyelinating lesions are found and spread in one or more areas related to breathing in the brain and spinal cord. The location and size of the plaques were associated with muscle weakness.
One of the methods used in the field of pulmonary rehabilitation in MS patients is Inspiratory Muscle Training (IMT). The muscles responsible for primary inspiration are the diaphragm, external intercostal muscles, and scalene muscles. Inspiratory muscle training increases inspiratory muscle strength, type 1 muscle fibers, reduces dyspnea, increases maximum minute ventilation and 6-minute walking distance and quality of life. It is usually applied at 30% of the maximal inspiratory pressure (MIP) value for 30 minutes a day.
The effect of the core muscles is great in providing balance and postural control. The diaphragm forms the roof of the core muscles and plays an important role in the mobility of the thorax. Training the diaphragm muscle, like other muscles, is important for maintaining dynamic and static balance. IMT can help stabilize thoracic mobility by strengthening the diaphragm and scalene muscles, contributing to the stability of chest movements and improving transfer skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Inspiratory Muscle Training, Other: Balance ExercisesIMT: Inspiratory Muscle Training. Five days per week, 30 minutes per day. |
| Control Group | Active comparator | Other: Balance ExercisesBalance exercises: It has been specially designed for the patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a diagnosis of relapsing-remitting MS with an EDSS of 1.5-5.5
- Having a Mini Mental Test score greater than 24
- Being between the ages of 18-65
Key exclusion criteria (4 listed)
- Having a neurological disease other than MS
- Having an attack while working
- Problems other than MS that may affect balance
- Have a diagnosis of cardiac or pulmonary disease that will affect breathing
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 TrainingInspiratory muscle training (IMT) is a therapeutic technique which involves specific training of respiratory muscles to yield improvements in inspiratory muscle strength and respiratory function. | Other | Treatment Group |
| Balance ExercisesBalance exercises involve functional movements at the individual's maximum level of independence. | Other | Control Group, Treatment Group |
Primary outcome
Mini-BesTEST
Time frame: Fifteen minutes
Mini-BESTest consists of 14 items divided into four subsections. In the Mini-BESTest evaluation, each item receives a three-point score. rated on an ordinal scale (0= lowest function ranging from level to 2= Normal function level). The total score is the sum of the scores obtained from these items. and ranges from 0 (worst) to 28 (best).
Trunk Impact Scale
Time frame: Ten minutes
The Trunk Impact Scale (TIS) consists of three subscales: static sitting balance, dynamic sitting balance and co-ordination. Each subscale contains between three and ten items. The TIS score ranges from a minimum of 0 to a maximum of 23.
5 secondary outcomes
Falls Efficacy Scale International
Time frame: Fifteen Minutes
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: Twenty minutes
Activities-Specific Balance Confidence Scale
Time frame: Ten Minutes
Two minutes walking test
Time frame: Four minutes
Pulmonary Function Test
Time frame: Ten minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 33296972Martin-Sanchez C, Calvo-Arenillas JI, Barbero-Iglesias FJ, Fonseca E, Sanchez-Santos JM, Martin-Nogueras AM. Effects of 12-week inspiratory muscle training with low resistance in patients with multiple sclerosis: A non-randomised, double-blind, controlled trial. Mult Scler Relat Disord. 2020 Nov;46:102574. doi: 10.1016/j.msard.2020.102574. Epub 2020 Oct 8.
- Background: PubMed 31707233Huang MH, Fry D, Doyle L, Burnham A, Houston N, Shea K, Smith H, Wiske L, Goode J, Khitrik E, Kolanda M. Effects of inspiratory muscle training in advanced multiple sclerosis. Mult Scler Relat Disord. 2020 Jan;37:101492. doi: 10.1016/j.msard.2019.101492. Epub 2019 Nov 1.
- Background: PubMed 16018157Inzelberg R, Peleg N, Nisipeanu P, Magadle R, Carasso RL, Weiner P. Inspiratory muscle training and the perception of dyspnea in Parkinson's disease. Can J Neurol Sci. 2005 May;32(2):213-7. doi: 10.1017/s0317167100003991.
- Derived from this study: PubMed 40848620Duman Ozkan T, Oguz S, Unal E, Emir C, Polat MG. Effects of inspiratory muscle training on balance, trunk control, fear of falling, respiratory function, and quality of life in people with multiple sclerosis: a randomized controlled trial. Mult Scler Relat Disord. 2025 Nov;103:106699. doi: 10.1016/j.msard.2025.106699. Epub 2025 Aug 18.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers.
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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 Inspiratory Muscle Training and Balance Exercises in people with Multiple Sclerosis, run by Marmara University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 6 May 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mini-BesTEST (time frame: Fifteen 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?
On the ClinicalTrials.gov record for NCT06075472, which also lists 4 linked publications.
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 6 May 2025.