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

NCT06075472 | Completed

• 1 other identifier: MarmaraU_DumanOzkan_01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 two groups. One group will be given only balance exercises. The other group will be given IMT treatment in addition to balance exercises.

Conditions

Multiple Sclerosis

Keywords

balance; inspiratory muscle training; postural control

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Ten minutes

Secondary Outcomes (5)

• Falls Efficacy Scale International

  Fifteen Minutes

• Multiple Sclerosis Quality of Life-54 (MSQOL-54)

  Twenty minutes

• Activities-Specific Balance Confidence Scale

  Ten Minutes

• Two minutes walking test

  Four minutes

• Pulmonary Function Test

  Ten minutes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Other: Inspiratory Muscle Training; Other: Balance Exercises

Control Group

ACTIVE COMPARATOR

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

Other: Balance Exercises

Interventions

Inspiratory Muscle Training 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.

Treatment Group

Balance Exercises OTHER

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

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Şişli, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 33296972 BACKGROUND

• 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.

  PMID: 31707233 BACKGROUND

• 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.

  PMID: 16018157 BACKGROUND

• 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 Nov;103:106699. doi: 10.1016/j.msard.2025.106699. Epub 2025 Aug 18.

  PMID: 40848620 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: October 10, 2023
• Study Start: March 6, 2023
• Primary Completion: February 26, 2024
• Study Completion: June 26, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)