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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Balance Exercises
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring balance, inspiratory muscle training, postural control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. Dr. Cemil Taşçıoğlu Şehir HastanesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
December 29, 2022
Last Updated
October 4, 2023
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT06075472
Brief Title
The Effect of Inspiratory Muscle Training on Balance and Postural Control in Multiple Sclerosis Patients
Official Title
The Effect of Inspiratory Muscle Training on Balance and Postural Control in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
February 26, 2024 (Anticipated)
Study Completion Date
June 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
balance, inspiratory muscle training, postural control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
IMT: Inspiratory Muscle Training. Five days per week, 30 minutes per day.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Balance exercises: It has been specially designed for the patient.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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
Intervention Name(s)
Balance Exercises
Intervention Description
Balance exercises involve functional movements at the individual's maximum level of independence.
Primary Outcome Measure Information:
Title
Mini-BesTEST
Description
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).
Time Frame
Fifteen minutes
Title
Trunk Impact Scale
Description
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.
Time Frame
Ten minutes
Secondary Outcome Measure Information:
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Fifteen Minutes
Title
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Description
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.
Time Frame
Twenty minutes
Title
Activities-Specific Balance Confidence Scale
Description
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.
Time Frame
Ten Minutes
Title
Two minutes walking test
Description
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.
Time Frame
Four minutes
Title
Pulmonary Function Test
Description
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.
Time Frame
Ten minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
City
Istanbul
State/Province
Şişli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elif Ünal, Consultant
Phone
0212 314 55 55
Email
elifunalmd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will not be shared with other researchers.
Citations:
PubMed Identifier
33296972
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.
Results Reference
background
PubMed Identifier
31707233
Citation
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.
Results Reference
background
PubMed Identifier
16018157
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.
Results Reference
background

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

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