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NCT Number: NCT06672770

Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis

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.

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Key information

Conditions

Core Muscles Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Functional Inspiratory Muscle Training Immune System Diseases Multiple Sclerosis Nervous System Diseases Respiratory Muscles

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location contact

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

About this study

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system and is a chronic and progressive disease characterized by inflammation, demyelination, and axonal degeneration. Due to axonal damage and demyelination, various neurological findings with motor and sensory losses are observed in patients with MS depending on their localization in the central nervous system. These findings vary depending on the location and size of the lesion, frequency, and severity of the disease. It is known that there are 2.8 million people living with MS in the world. Generally, the first symptoms appear between the ages of 20-40, but it is defined as early-onset or pediatric under the age of 18, adult-onset between the ages of 18-49, and late-onset after the age of 50. It is approximately twice as common in women, and is more common between the ages of 20-50, especially in white races. Although four clinical types are defined in MS: relapsing remitting MS, primary progressive MS, secondary progressive MS, relapsing progressive MS, clinically isolated MS has been added to the current classification, and the relapsing progressive MS classification has been abolished and those in this classification have been included in the primary progressive MS class. The relapsing remitting type is the most common, and there are periods of exacerbation (relapse) and remission in this type. Complications that occur during the exacerbation period show full or near-full recovery during the remission period. Various neurological findings such as spasticity, muscle weakness, gait disturbance, cognitive impairment, swallowing problems, bladder-bowel dysfunction can be observed in MS patients, and respiratory complications constitute one of the most common and important causes of death in MS. The risk of death is almost 12 times higher due to respiratory complications, which constitute approximately 47% of the causes of death in MS. Involvement of the pulmonary system, which is usually observed to have deterioration in diffusion capacity, respiratory muscle strength, and ventilation-perfusion ratio, leads to exercise intolerance, hospitalization, and mortality in MS. In MS, the primary factor is the formation of demyelinating plaques in the central nervous system, and the secondary factors include medications used, fatigue due to the disease, increased body temperature, a sedentary lifestyle, and loss of fitness, which all come together to cause pulmonary effects such as respiratory muscle weakness, lung volume deterioration, neurogenic pulmonary edema, sleep-disordered breathing, impaired respiratory control, decreased coughing efficiency, and respiratory failure. When the literature is examined, it seems that there is a need to try new methods in these disease groups to prevent respiratory complications and improve respiration due to pulmonary effects seen in MS. This study aims to investigate the effects of functional inspiratory muscle training, basic inspiratory muscle training, and physical activity applied in addition to respiratory exercises on respiratory muscle strength, respiratory function, cognitive function, walking, balance, functional exercise capacity, physical activity, quality of life, and core muscles in patients with Relapsing Remitting type Multiple Sclerosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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:

  • Diaphragmatic breathing exercises
  • Warm-up exercises
  • Trunk strength and lumbopelvic stability exercises
  • Dynamic trunk exercises
  • Postural control exercises
  • Cool-down exercises

Basic Inspiratory Muscle Training

Other

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

Primary outcomes

  1. Inspiratory Respiratory Muscle Strength

    Time frame: 8 weeks

    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.

  2. Expiratory Respiratory Muscle Strength

    Time frame: 8 weeks

    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.

  3. Respiratory Function (FEV₁)

    Time frame: 8 weeks

    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.

  4. Respiratory Function (FVC)

    Time frame: 8 weeks

    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.

  5. Respiratory Function (FEV₁/FVC)

    Time frame: 8 weeks

    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.

  6. Respiratory Function (PEF)

    Time frame: 8 weeks

    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.

  7. Respiratory Function (FEF%25-75)

    Time frame: 8 weeks

    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. Respiratory Function (VC)

    Time frame: 8 weeks

    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.

  9. Paced Auditory Serial Addition Test (PASAT)

    Time frame: 8 weeks

    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.

  10. Symbol Digit Modalities Test (SDMT)

    Time frame: 8 weeks

    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.

  11. Stroop Test

    Time frame: 8 weeks

    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."

  12. Walking

    Time frame: 8 weeks

    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.

  13. Balance

    Time frame: 8 weeks

    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.

  14. Functional Exercise Capacity

    Time frame: 8 weeks

    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.

  15. Physical Activity

    Time frame: 8 weeks

    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).

  16. Quality of Life

    Time frame: 8 weeks

    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.

  17. Core Muscles (Pelvic Bridge Test)

    Time frame: 8 weeks

    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.

  18. Core Muscles (Modified Plank Test)

    Time frame: 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Investigation of the Effects of Functional Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Exercise Capacity and Cognitive Function in Patients with Multiple Sclerosis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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