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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075472
• Other study ID #: MarmaraU_DumanOzkan_01
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: June 26, 2024

Study information

• Verified date: October 2023
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Respiratory Aspiration
• Sclerosis

Intervention

Other:
• 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.
• Balance Exercises
Balance exercises involve functional movements at the individual's maximum level of independence.

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tasçioglu Sehir Hastanesi	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	Fifteen Minutes
Secondary	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.	Twenty minutes
Secondary	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.	Ten Minutes
Secondary	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.	Four minutes
Secondary	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.	Ten minutes