Core MusclesNCT06672770

Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis

A study testing Functional Inspiratory Muscle Training and Basic Inspiratory Muscle Training in people with Core Muscles and Functional Inspiratory Muscle Training, run by Selcuk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study aims to investigate the effects of functional inspiratory muscle training, basic inspiratory muscle training and physical activity in addition to respiratory exercises on respiratory muscle strength, respiratory function, cognition, walking, balance, functional exercise capacity, physical activity, quality… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Core Muscles, Functional Inspiratory Muscle Training, Multiple Sclerosis
What is being tested?: Functional Inspiratory Muscle Training and Basic Inspiratory Muscle Training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Nov 2024to 20 Dec 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Diagnosed with Relapsing Remitting Type Multiple Sclerosis (RRMS),
EDSS (Expanded Disability Status Scale in MS: EDSS) score ranging from 1-5,
Able to communicate (speak, understand, read and understand Turkish),
Individuals who have not had an attack in the last three months,
Individuals who have not received respiratory-based rehabilitation in the last six months will be included in the study.

Who cannot join

Those with neurological diseases other than MS,
Those who have functional exercise restrictions,
Those with chronic cardiac or pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
Individuals who have had pneumonia due to viral or bacterial infection in the last six months or COVID-19 positive individuals proven by PCR-RT,
Those with orthopedic problems, persistent neck and back pain and/or radiculopathy that prevent them from participating in the study,
Those with diagnosed psychiatric disorders,
Those who use tobacco and tobacco products,
Participants with cooperation problems that may prevent evaluations and treatment will not be included in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Konya, Selcuklu, 42130
Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Functional Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Exercise Capacity and Cognitive Function in Patients with Multiple Sclerosis

Read the detailed description

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system and is a chronic and progressive disease characterized by inflammation, demyelination, and axonal degeneration. Due to axonal damage and demyelination, various neurological findings with motor and sensory losses are observed in patients with MS depending on their localization in the central nervous system. These findings vary depending on the location and size of the lesion, frequency, and severity of the disease. It is known that there are 2.8 million people living with MS in the world. Generally, the first symptoms appear between the ages of 20-40, but it is defined as early-onset or pediatric under the age of 18, adult-onset between the ages of 18-49, and late-onset after the age of 50. It is approximately twice as common in women, and is more common between the ages of 20-50, especially in white races. Although four clinical types are defined in MS: relapsing remitting MS, primary progressive MS, secondary progressive MS, relapsing progressive MS, clinically isolated MS has been added to the current classification, and the relapsing progressive MS classification has been abolished and those in this classification have been included in the primary progressive MS class. The relapsing remitting type is the most common, and there are periods of exacerbation (relapse) and remission in this type. Complications that occur during the exacerbation period show full or near-full recovery during the remission period. Various neurological findings such as spasticity, muscle weakness, gait disturbance, cognitive impairment, swallowing problems, bladder-bowel dysfunction can be observed in MS patients, and respiratory complications constitute one of the most common and important causes of death in MS. The risk of death is almost 12 times higher due to respiratory complications, which constitute approximately 47% of the causes of death in MS. Involvement of the pulmonary system, which is usually observed to have deterioration in diffusion capacity, respiratory muscle strength, and ventilation-perfusion ratio, leads to exercise intolerance, hospitalization, and mortality in MS. In MS, the primary factor is the formation of demyelinating plaques in the central nervous system, and the secondary factors include medications used, fatigue due to the disease, increased body temperature, a sedentary lifestyle, and loss of fitness, which all come together to cause pulmonary effects such as respiratory muscle weakness, lung volume deterioration, neurogenic pulmonary edema, sleep-disordered breathing, impaired respiratory control, decreased coughing efficiency, and respiratory failure. When the literature is examined, it seems that there is a need to try new methods in these disease groups to prevent respiratory complications and improve respiration due to pulmonary effects seen in MS. This study aims to investigate the effects of functional inspiratory muscle training, basic inspiratory muscle training, and physical activity applied in addition to respiratory exercises on respiratory muscle strength, respiratory function, cognitive function, walking, balance, functional exercise capacity, physical activity, quality of life, and core muscles in patients with Relapsing Remitting type Multiple Sclerosis.

Conditions: Core Muscles, Functional Inspiratory Muscle Training, Multiple Sclerosis, Respiratory Muscles
Being tested: Functional Inspiratory Muscle Training, Basic Inspiratory Muscle Training
Keywords: Core muscles, Functional inspiratory muscle training, Multiple sclerosis, Respiratory muscles
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Functional Inspiratory Muscle TrainingOther
The functional inspiratory muscle training group will perform basic inspiratory muscle training in the first four weeks of the study and the following exercises with the Powerbreath device in muscle training in the following four weeks:
1. Diaphragmatic breathing exercises
2. Warm-up exercises
3. Trunk strength and lumbopelvic stability exercises
4. Dynamic trunk exercises
5. Postural control exercises
6. Cool-down exercises
Basic Inspiratory Muscle TrainingOther
The basic inspiratory muscle training group will do muscle training with the POWERbreathe device for eight weeks.

Study groups in NCT06672770
Study group	Role	What they receive
Functional Inspiratory Muscle Training Group	Experimental	The functional inspiratory muscle training (FIMT) group (n=21) will receive basic inspiratory muscle training (IMT) with a device capable of delivering threshold pressure loading (POWERbreathe) for the first four weeks. The first, middle and last sessions of the week will be supervised (face-to-face) and other sessions will be unsupervised (at home, twice a day, totaling 30 minutes). The intensity of inspiratory muscle training will be adjusted to 50-60% of maximal inspiratory pressure and these measurements will be repeated at the beginning of each week and weekly pressure increases will be adjusted. After the first four weeks are completed, then inspiratory muscle training will be combined with exercises at the beginning of the fifth week, and participants will perform supervised in-person FIMT three days per week for four weeks and unsupervised home IMT on the remaining days. Receives: Other: Functional Inspiratory Muscle Training
Basic Inspiratory Muscle Training Group	Experimental	Basic inspiratory muscle training (IMT) group (n=21) will be given IMT with a device capable of performing threshold pressure loading (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) for eight weeks. The first day of the week, the middle of the week and the last session will be supervised (face-to-face), and the other sessions will be unsupervised (at home, twice a day, 30 minutes in total). The intensity of inspiratory muscle training will be adjusted to be 50-60% of the maximal inspiratory pressure, and these measurements will be repeated at the beginning of each week and weekly pressure increases will be adjusted. Receives: Other: Basic Inspiratory Muscle Training
Control Group	No intervention	Participants in the control group (n=21) will be informed about the benefits of at least 150-300 minutes of moderate intensity or 75-150 minutes of vigorous intensity aerobic physical activity and breathing exercises per week and exercise recommendations will be given. Both daily physical activities and breathing exercises will be monitored with a pre-prepared exercise tracking form. Participants will be called to the laboratory for clinical measurements at the beginning and end of the study. Participants in the control group will be taught to do diaphragmatic breathing, thoracic expansion, pursed lip breathing and breath control breathing exercises for 20 minutes a day and will be given as home exercises without supervision, with 1-2 minutes of rest between each exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

Inspiratory Respiratory Muscle Strength
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can measure intraoral pressure electronically, which is a non-invasive method, and the results will be recorded as maximal inspiratory pressure (MIP). The participant's nose will be closed with a valve while they are maximally expiratory in a sitting position, and a maximal inspiration will be requested for 1 - 3 seconds to complete the MIP measurement and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Measured: 8 weeks
Expiratory Respiratory Muscle Strength
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can electronically measure intraoral pressure, which is a non-invasive method, and the results will be recorded as maximal expiratory pressure (MEP). MEP measurement will be completed by closing the nose of the participant who is maximally inspiratory in a sitting position with a valve and asking the participant to exhale maximally for 1-3 seconds, and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Measured: 8 weeks
Respiratory Function (FEV₁)
Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria set by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume (FEV₁) in the first second of the lung function test.
Measured: 8 weeks
Respiratory Function (FVC)
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced vital capacity (FVC) of the lung function test.
Measured: 8 weeks
Respiratory Function (FEV₁/FVC)
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume in the first second/forced vital capacity ratio (FEV₁/FVC) of the lung function test.
Measured: 8 weeks
Respiratory Function (PEF)
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring peak expiratory flow rate (PEF) of the lung function test.
Measured: 8 weeks
Respiratory Function (FEF%25-75)
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring forced expiratory midflow rate (FEF%25-75) of the lung function test.
Measured: 8 weeks
Respiratory Function (VC)
Respiratory function will be assessed with a portable spirometer with the patient in a sitting position according to the criteria determined by the American Thoracic Society and the European Respiratory Society. The test will be repeated three times. Participants will be asked to inhale deeply and exhale deeply for sixty seconds. As a result of three consecutive tests, the highest and percentages of the expected vital capacity (VC) values of respiratory function will be obtained.
Measured: 8 weeks
Paced Auditory Serial Addition Test (PASAT)
PASAT test is a test used to evaluate attention, processing speed and working memory. Within the scope of the test, participants are required to add numbers given at a certain speed and add each new number to the previous number.
Measured: 8 weeks
Symbol Digit Modalities Test (SDMT)
This test is a test that measures cognitive processing speed. Patients match the numbers corresponding to certain symbols by finding their equivalents as much as possible.
Measured: 8 weeks
Stroop Test
The Stroop test will be used to measure executive functions and attention control. Participants are asked to name the ink colors of words written with color names. For example, when the word "green" is written in blue ink, participants should say "blue."
Measured: 8 weeks
Walking
Participants' walking will be evaluated with a 10-meter walking test. Participants will be positioned at the starting line in a pre-measured 10-meter area and the time will be started when the participant steps on the starting line. If the participant uses a walking aid, they will be allowed to walk with it and the measurement will be made twice. The time will end when the participant crosses the finish line at the end of the 10 meters and the best value will be recorded in m/sec.
Measured: 8 weeks
Balance
Balance will be evaluated with a timed up and go test. The participant, sitting on the chair, with feet flat on the floor and arms resting on the chair rest, will be asked to get up from the chair, walk the previously measured three-meter area at a safe and normal pace, turn, walk back, and sit back on the chair. The time will be measured in seconds for three repetitions and the best result will be recorded.
Measured: 8 weeks
Functional Exercise Capacity
The functional exercise capacity of the participants will be measured with a 6-minute walk test. The 6-minute walk test is used to determine the maximum distance the participant can walk in six minutes. It is used to measure walking fatigue and walking endurance. Before starting the test, the participants will be informed that they will have to walk as fast as possible without running in a thirty-meter corridor for six minutes and that they can rest by taking a break if they wish, but their rest periods will not be added to the six minutes. The participants will be encouraged once per minute with standard expressions during walking. The distance the participant has walked at the end of the six minutes will be recorded in meters.
Measured: 8 weeks
Physical Activity
Participants' physical activity status will be assessed with the International Physical Activity Questionnaire short form (SF-IPAQ). The survey consists of seven questions. The duration and frequency of each activity performed in the last week are questioned in the survey. The MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs) and vigorous-intensity physical activity (8.0 METs) will be multiplied by duration (minutes) and frequency (days) to reach physical activity score values (MET-min/week).
Measured: 8 weeks
Quality of Life
The participants' quality of life will be assessed with the Multiple Sclerosis International Quality of Life Questionnaire, a MS-specific assessment scale. The scale consists of nine subgroups; Daily Living Activities, Psychological Status, Findings, Relationships with Friends, Family Relations, Emotional and Sexual Life, Acceptance of the Disease, Coping with the Disease and Relationships with Medical Personnel. Each question in this scale, consisting of a total of 31 questions, is scored between 0-4 as "Never, Never" (0 points), "Rarely, A Little" (1 point), "Sometimes, A Little" (2 points), "Frequently, A Lot" (3 points), "Always, A Lot" (4 points). In the evaluation, the total score is calculated and the actual score is obtained by dividing by 1.24 for linear transformation, since the maximum score that can be obtained from the scale is 124. Low scores indicate high quality of life.
Measured: 8 weeks
Core Muscles (Pelvic Bridge Test)
The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. For the pelvic bridge test, participants will be asked to lie on their backs with their knees flexed and their arms extended at their sides, and then they will be instructed to straighten their trunk by lifting their pelvic region. The time they can maintain this position will be recorded.
Measured: 8 weeks
Core Muscles (Modified Plank Test)
The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. In the modified plank test, participants will be shown a series of movements and the time they maintain these positions will be recorded and measured.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202420 Dec 2025

First posted4 Nov 2024
Study start1 Nov 2024 (estimated)
Primary completion31 Oct 2025 (estimated)
Study completion20 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Core MusclesStudies of the same condition, open and under way.
More trials run by Selcuk 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: MS patients will be divided into 3 groups as functional inspiratory muscle training (FIMT) group (n=21), basic inspiratory muscle training (IMT) group (n=21) and Control (CT) group (n=21) by block randomization with the randomization program "https://www.studyrandomizer.com/".
Masking: None (open label)
Enrolment: 63 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06672770
Sponsor's protocol ID: SelcukU_PT_MS_FIMT-IMT_Resp.01
Status last verified: Nov 2024
First submitted: 30 Oct 2024
Last updated: 4 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tong TK, Wu S, Nie J. Sport-specific endurance plank test for evaluation of global core muscle function. Phys Ther Sport. 2014 Feb;15(1):58-63. doi: 10.1016/j.ptsp.2013.03.003. Epub 2013 Jul 11.
PubMed 23850461
Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
PubMed 17942521
Shubert TE, Schrodt LA, Mercer VS, Busby-Whitehead J, Giuliani CA. Are scores on balance screening tests associated with mobility in older adults? J Geriatr Phys Ther. 2006;29(1):35-9.
PubMed 16630375
Savcı, F. D. S., Öztürk, U. F. M., & Arıkan, F. D. H. (2006). Üniversite öğrencilerinin fiziksel aktivite düzeyleri. Türk Kardiyol Dern Arfl, 34(3), 166-172.
Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
PubMed 21058606
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
PubMed 16264058
Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
PubMed 10412550
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882
Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004 Aug;52(8):1343-8. doi: 10.1111/j.1532-5415.2004.52366.x.
PubMed 15271124
IPAQ Research Committee. (2005). Guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ)-short and long forms.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180
Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
PubMed 18296944
McConnell, A. (2013). Respiratory muscle training: theory and practice. Elsevier Health Sciences.
Dereli, M., Ozcan Kahraman, B., & Kahraman, T. (2022). A narrative review of respiratory impairment, assessment, and rehabilitation in multiple sclerosis. Dubai Medical Journal, 5(1), 78-88.
Tzelepis GE, McCool FD. Respiratory dysfunction in multiple sclerosis. Respir Med. 2015 Jun;109(6):671-9. doi: 10.1016/j.rmed.2015.01.018. Epub 2015 Feb 12.
PubMed 25724874

Interested in taking part?

Mehmet K ALTUNOK, PHD(c) in PT

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effects of Functional Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Exercise Capacity and Cognitive Function in Patients with Multiple Sclerosis
ClinicalTrials.gov ID: NCT06672770
Acronym / sponsor ID: SelcukU_PT_MS_FIMT-IMT_Resp.01
Conditions: Core Muscles, Functional Inspiratory Muscle Training, Multiple Sclerosis, Respiratory Muscles
Keywords: Core muscles, Functional inspiratory muscle training, Multiple sclerosis, Respiratory muscles
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 63 participants (estimated)
Lead sponsor: Selcuk UniversityUniversity, hospital or other
Study start: 1 Nov 2024 (estimated)
Primary completion: 31 Oct 2025 (estimated)
Study completion: 20 Dec 2025 (estimated)
First posted: 4 Nov 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: MS patients will be divided into 3 groups as functional inspiratory muscle training (FIMT) group (n=21), basic inspiratory muscle training (IMT) group (n=21) and Control (CT) group (n=21) by block randomization with the randomization program "https://www.studyrandomizer.com/".

Arm	Type	Receives
Functional Inspiratory Muscle Training Group	Experimental	Other: Functional Inspiratory Muscle TrainingThe functional inspiratory muscle training (FIMT) group (n=21) will receive basic inspiratory muscle training (IMT) with a device capable of delivering threshold pressure loading (POWERbreathe) for the first four weeks. The first, middle and last sessions of the week will be supervised (face-to-face) and other sessions will be unsupervised (at home, twice a day, totaling 30 minutes). The intensity of inspiratory muscle training will be adjusted to 50-60% of maximal inspiratory pressure and these measurements will be repeated at the beginning of each week and weekly pressure increases will be adjusted. After the first four weeks are completed, then inspiratory muscle training will be combined with exercises at the beginning of the fifth week, and participants will perform supervised in-person FIMT three days per week for four weeks and unsupervised home IMT on the remaining days.
Basic Inspiratory Muscle Training Group	Experimental	Other: Basic Inspiratory Muscle TrainingBasic inspiratory muscle training (IMT) group (n=21) will be given IMT with a device capable of performing threshold pressure loading (POWERbreathe Classic Light Resistance, PowerBreath, IMT Technologies Ltd, Birmingham, UK) for eight weeks. The first day of the week, the middle of the week and the last session will be supervised (face-to-face), and the other sessions will be unsupervised (at home, twice a day, 30 minutes in total). The intensity of inspiratory muscle training will be adjusted to be 50-60% of the maximal inspiratory pressure, and these measurements will be repeated at the beginning of each week and weekly pressure increases will be adjusted.
Control Group	No intervention	–Participants in the control group (n=21) will be informed about the benefits of at least 150-300 minutes of moderate intensity or 75-150 minutes of vigorous intensity aerobic physical activity and breathing exercises per week and exercise recommendations will be given. Both daily physical activities and breathing exercises will be monitored with a pre-prepared exercise tracking form. Participants will be called to the laboratory for clinical measurements at the beginning and end of the study. Participants in the control group will be taught to do diaphragmatic breathing, thoracic expansion, pursed lip breathing and breath control breathing exercises for 20 minutes a day and will be given as home exercises without supervision, with 1-2 minutes of rest between each exercise.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosed with Relapsing Remitting Type Multiple Sclerosis (RRMS),
EDSS (Expanded Disability Status Scale in MS: EDSS) score ranging from 1-5,
Able to communicate (speak, understand, read and understand Turkish),
Individuals who have not had an attack in the last three months,
Individuals who have not received respiratory-based rehabilitation in the last six months will be included in the study.

Key exclusion criteria (8 listed)

Those with neurological diseases other than MS,
Those who have functional exercise restrictions,
Those with chronic cardiac or pulmonary diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease and heart failure that may affect respiratory muscle strength and respiratory functions,
Individuals who have had pneumonia due to viral or bacterial infection in the last six months or COVID-19 positive individuals proven by PCR-RT,
Those with orthopedic problems, persistent neck and back pain and/or radiculopathy that prevent them from participating 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
Functional Inspiratory Muscle TrainingThe functional inspiratory muscle training group will perform basic inspiratory muscle training in the first four weeks of the study and the following exercises with the Powerbreath device in muscle training in the following four weeks: 1. Diaphragmatic breathing exercises 2. Warm-up exercises 3. Trunk strength and lumbopelvic stability exercises 4. Dynamic trunk exercises 5. Postural control exercises 6. Cool-down exercises	Other	Functional Inspiratory Muscle Training Group
Basic Inspiratory Muscle TrainingThe basic inspiratory muscle training group will do muscle training with the POWERbreathe device for eight weeks.	Other	Basic Inspiratory Muscle Training Group

Primary outcome

Inspiratory Respiratory Muscle Strength
Time frame: 8 weeks
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can measure intraoral pressure electronically, which is a non-invasive method, and the results will be recorded as maximal inspiratory pressure (MIP). The participant's nose will be closed with a valve while they are maximally expiratory in a sitting position, and a maximal inspiration will be requested for 1 - 3 seconds to complete the MIP measurement and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Expiratory Respiratory Muscle Strength
Time frame: 8 weeks
Participants' respiratory muscle strength will be measured with a portable device (Micro Medical Micro RPM, UK) that can electronically measure intraoral pressure, which is a non-invasive method, and the results will be recorded as maximal expiratory pressure (MEP). MEP measurement will be completed by closing the nose of the participant who is maximally inspiratory in a sitting position with a valve and asking the participant to exhale maximally for 1-3 seconds, and the measurements will be recorded. The highest of the three best results, with no more than 10% difference between them, among at least five measurements will be recorded as the final data.
Respiratory Function (FEV₁)
Time frame: 8 weeks
Respiratory functions will be assessed with a portable spirometer with the patient in a sitting position according to the criteria set by the American Thoracic Society and the European Respiratory Society. Spirometry measures multiple parameters during a single test. Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume (FEV₁) in the first second of the lung function test.
Respiratory Function (FVC)
Time frame: 8 weeks
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced vital capacity (FVC) of the lung function test.
Respiratory Function (FEV₁/FVC)
Time frame: 8 weeks
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring the forced expiratory volume in the first second/forced vital capacity ratio (FEV₁/FVC) of the lung function test.
Respiratory Function (PEF)
Time frame: 8 weeks
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring peak expiratory flow rate (PEF) of the lung function test.
Respiratory Function (FEF%25-75)
Time frame: 8 weeks
Participants will be asked to take a single forced breath during normal breathing and then exhale a single forced breath, measuring forced expiratory midflow rate (FEF%25-75) of the lung function test.
Respiratory Function (VC)
Time frame: 8 weeks
Respiratory function will be assessed with a portable spirometer with the patient in a sitting position according to the criteria determined by the American Thoracic Society and the European Respiratory Society. The test will be repeated three times. Participants will be asked to inhale deeply and exhale deeply for sixty seconds. As a result of three consecutive tests, the highest and percentages of the expected vital capacity (VC) values of respiratory function will be obtained.
Paced Auditory Serial Addition Test (PASAT)
Time frame: 8 weeks
PASAT test is a test used to evaluate attention, processing speed and working memory. Within the scope of the test, participants are required to add numbers given at a certain speed and add each new number to the previous number.
Symbol Digit Modalities Test (SDMT)
Time frame: 8 weeks
This test is a test that measures cognitive processing speed. Patients match the numbers corresponding to certain symbols by finding their equivalents as much as possible.
Stroop Test
Time frame: 8 weeks
The Stroop test will be used to measure executive functions and attention control. Participants are asked to name the ink colors of words written with color names. For example, when the word "green" is written in blue ink, participants should say "blue."
Walking
Time frame: 8 weeks
Participants' walking will be evaluated with a 10-meter walking test. Participants will be positioned at the starting line in a pre-measured 10-meter area and the time will be started when the participant steps on the starting line. If the participant uses a walking aid, they will be allowed to walk with it and the measurement will be made twice. The time will end when the participant crosses the finish line at the end of the 10 meters and the best value will be recorded in m/sec.
Balance
Time frame: 8 weeks
Balance will be evaluated with a timed up and go test. The participant, sitting on the chair, with feet flat on the floor and arms resting on the chair rest, will be asked to get up from the chair, walk the previously measured three-meter area at a safe and normal pace, turn, walk back, and sit back on the chair. The time will be measured in seconds for three repetitions and the best result will be recorded.
Functional Exercise Capacity
Time frame: 8 weeks
The functional exercise capacity of the participants will be measured with a 6-minute walk test. The 6-minute walk test is used to determine the maximum distance the participant can walk in six minutes. It is used to measure walking fatigue and walking endurance. Before starting the test, the participants will be informed that they will have to walk as fast as possible without running in a thirty-meter corridor for six minutes and that they can rest by taking a break if they wish, but their rest periods will not be added to the six minutes. The participants will be encouraged once per minute with standard expressions during walking. The distance the participant has walked at the end of the six minutes will be recorded in meters.
Physical Activity
Time frame: 8 weeks
Participants' physical activity status will be assessed with the International Physical Activity Questionnaire short form (SF-IPAQ). The survey consists of seven questions. The duration and frequency of each activity performed in the last week are questioned in the survey. The MET values defined for walking (3.3 METs), moderate-intensity physical activity (4.0 METs) and vigorous-intensity physical activity (8.0 METs) will be multiplied by duration (minutes) and frequency (days) to reach physical activity score values (MET-min/week).
Quality of Life
Time frame: 8 weeks
The participants' quality of life will be assessed with the Multiple Sclerosis International Quality of Life Questionnaire, a MS-specific assessment scale. The scale consists of nine subgroups; Daily Living Activities, Psychological Status, Findings, Relationships with Friends, Family Relations, Emotional and Sexual Life, Acceptance of the Disease, Coping with the Disease and Relationships with Medical Personnel. Each question in this scale, consisting of a total of 31 questions, is scored between 0-4 as "Never, Never" (0 points), "Rarely, A Little" (1 point), "Sometimes, A Little" (2 points), "Frequently, A Lot" (3 points), "Always, A Lot" (4 points). In the evaluation, the total score is calculated and the actual score is obtained by dividing by 1.24 for linear transformation, since the maximum score that can be obtained from the scale is 124. Low scores indicate high quality of life.
Core Muscles (Pelvic Bridge Test)
Time frame: 8 weeks
The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. For the pelvic bridge test, participants will be asked to lie on their backs with their knees flexed and their arms extended at their sides, and then they will be instructed to straighten their trunk by lifting their pelvic region. The time they can maintain this position will be recorded.
Core Muscles (Modified Plank Test)
Time frame: 8 weeks
The pelvic bridge test and modified plank test will be used to assess the stabilization of the core muscles. In the modified plank test, participants will be shown a series of movements and the time they maintain these positions will be recorded and measured.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Background: PubMed 23850461Tong TK, Wu S, Nie J. Sport-specific endurance plank test for evaluation of global core muscle function. Phys Ther Sport. 2014 Feb;15(1):58-63. doi: 10.1016/j.ptsp.2013.03.003. Epub 2013 Jul 11.
Background: PubMed 17942521Simeoni M, Auquier P, Fernandez O, Flachenecker P, Stecchi S, Constantinescu C, Idiman E, Boyko A, Beiske A, Vollmer T, Triantafyllou N, O'Connor P, Barak Y, Biermann L, Cristiano E, Atweh S, Patrick D, Robitail S, Ammoury N, Beresniak A, Pelletier J; MusiQol study group. Validation of the Multiple Sclerosis International Quality of Life questionnaire. Mult Scler. 2008 Mar;14(2):219-30. doi: 10.1177/1352458507080733. Epub 2007 Oct 17.
Background: PubMed 16630375Shubert TE, Schrodt LA, Mercer VS, Busby-Whitehead J, Giuliani CA. Are scores on balance screening tests associated with mobility in older adults? J Geriatr Phys Ther. 2006;29(1):35-9.
BackgroundSavcı, F. D. S., Öztürk, U. F. M., & Arıkan, F. D. H. (2006). Üniversite öğrencilerinin fiziksel aktivite düzeyleri. Türk Kardiyol Dern Arfl, 34(3), 166-172.
Background: PubMed 21058606Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
Background: PubMed 16264058Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
Background: PubMed 10412550Neder JA, Andreoni S, Lerario MC, Nery LE. Reference values for lung function tests. II. Maximal respiratory pressures and voluntary ventilation. Braz J Med Biol Res. 1999 Jun;32(6):719-27. doi: 10.1590/s0100-879x1999000600007.
Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Background: PubMed 15271124Lin MR, Hwang HF, Hu MH, Wu HD, Wang YW, Huang FC. Psychometric comparisons of the timed up and go, one-leg stand, functional reach, and Tinetti balance measures in community-dwelling older people. J Am Geriatr Soc. 2004 Aug;52(8):1343-8. doi: 10.1111/j.1532-5415.2004.52366.x.
BackgroundIPAQ Research Committee. (2005). Guidelines for data processing and analysis of the International Physical Activity Questionnaire (IPAQ)-short and long forms.
Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
Background: PubMed 18296944Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
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.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

İsmail ÖZSOY, Assoc. Prof. Dr. study director

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

Selen GUR OZMEN, Assoc. Prof. Dr. study director

Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 4 Nov 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory Respiratory Muscle Strength (time frame: 8 weeks). The study lists 18 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 NCT06672770, which also lists 27 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 4 Nov 2024.