The Effect of Inspiratory Muscle Training on Balance and Postural Control in Multiple Sclerosis Patients

NCT ID: NCT06075472

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2024-06-26

Brief Summary

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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

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

IMT: Inspiratory Muscle Training. Five days per week, 30 minutes per day.

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type OTHER

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 Exercises

Intervention Type OTHER

Balance exercises involve functional movements at the individual's maximum level of independence.

Control Group

Balance exercises: It has been specially designed for the patient.

Group Type ACTIVE_COMPARATOR

Balance Exercises

Intervention Type OTHER

Balance exercises involve functional movements at the individual's maximum level of independence.

Interventions

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Inspiratory Muscle Training

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.

Intervention Type OTHER

Balance Exercises

Balance exercises involve functional movements at the individual's maximum level of independence.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Tuğçe Duman Özkan

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Şişli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33296972 (View on PubMed)

Huang 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.

Reference Type BACKGROUND
PMID: 31707233 (View on PubMed)

Inzelberg 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.

Reference Type BACKGROUND
PMID: 16018157 (View on PubMed)

Duman 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 Aug 18;103:106699. doi: 10.1016/j.msard.2025.106699. Online ahead of print.

Reference Type DERIVED
PMID: 40848620 (View on PubMed)

Other Identifiers

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MarmaraU_DumanOzkan_01

Identifier Type: -

Identifier Source: org_study_id

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