Clinical trial NCT06672770: Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Core Muscles
Functional Inspiratory Muscle Training
Multiple Sclerosis
Respiratory Muscles
Keywords: Core muscles
Functional inspiratory muscle training
Multiple sclerosis
Respiratory muscles
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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/".
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inspiratory Respiratory Muscle Strength
timeFrame: 8 weeks
measure: Expiratory Respiratory Muscle Strength
timeFrame: 8 weeks
measure: Respiratory Function (FEV₁)
timeFrame: 8 weeks
measure: Respiratory Function (FVC)
timeFrame: 8 weeks
measure: Respiratory Function (FEV₁/FVC)
timeFrame: 8 weeks
measure: Respiratory Function (PEF)
timeFrame: 8 weeks
measure: Respiratory Function (FEF%25-75)
timeFrame: 8 weeks
measure: Respiratory Function (VC)
timeFrame: 8 weeks
measure: Paced Auditory Serial Addition Test (PASAT)
timeFrame: 8 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 8 weeks
measure: Stroop Test
timeFrame: 8 weeks
measure: Walking
timeFrame: 8 weeks
measure: Balance
timeFrame: 8 weeks
measure: Functional Exercise Capacity
timeFrame: 8 weeks
measure: Physical Activity
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
measure: Core Muscles (Pelvic Bridge Test)
timeFrame: 8 weeks
measure: Core Muscles (Modified Plank Test)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Selcuklu
Study officials:
affiliation: Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
name: İsmail ÖZSOY, Assoc. Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul, Türkiye
name: Selen GUR OZMEN, Assoc. Prof. Dr.
role: STUDY_DIRECTOR
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