Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis

NCT06672770 | Not Yet Recruiting

• 1 other identifier: SelcukU_PT_MS_FIMT-IMT_Resp.01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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 of life and core muscles in volunteer Multiple Sclerosis (MS) patients. This study is planned as a prospective, randomized and experimental study.

Conditions

Core Muscles; Functional Inspiratory Muscle Training; Multiple Sclerosis; Respiratory Muscles

Keywords

Core muscles; Functional inspiratory muscle training; Multiple sclerosis; Respiratory muscles

Outcome Measures

Primary Outcomes (18)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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."

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  8 weeks

Study Arms (3)

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.

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.

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.

Interventions

Functional Inspiratory Muscle Training OTHER

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

Functional Inspiratory Muscle Training Group

Basic Inspiratory Muscle Training OTHER

The basic inspiratory muscle training group will do muscle training with the POWERbreathe device for eight weeks.

Basic Inspiratory Muscle Training 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

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

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

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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 Officials

• İsmail ÖZSOY, Assoc. Prof. Dr.

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

  STUDY DIRECTOR

• Selen GUR OZMEN, Assoc. Prof. Dr.

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

  STUDY DIRECTOR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

5558175133; mehmetkaan.altunok@selcuk.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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/".

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: November 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 20, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)