Effect of Functional Inspiratory Muscle Training in Patients with Multiple Sclerosis

NCT ID: NCT06672770

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Functional Inspiratory Muscle Training Group

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.

Group Type: EXPERIMENTAL

Functional Inspiratory Muscle Training

Intervention Type: 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

Basic Inspiratory Muscle Training Group

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.

Group Type: EXPERIMENTAL

Basic Inspiratory Muscle Training

Intervention Type: OTHER

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

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Functional Inspiratory Muscle Training

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

Intervention Type: OTHER

Basic Inspiratory Muscle Training

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Kaan ALTUNOK

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İsmail ÖZSOY, Assoc. Prof. Dr.

Role: STUDY_DIRECTOR

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

Selen GUR OZMEN, Assoc. Prof. Dr.

Role: STUDY_DIRECTOR

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

Locations

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

Konya, Selcuklu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Mehmet K ALTUNOK, PHD(c) in PT

Role: CONTACT

mehmetkaan.altunok@selcuk.edu.tr

5558175133 ext. +90

Facility Contacts

Mehmet K ALTUNOK, PHD(c) in PT

Role: primary

mehmetkaan.altunok@selcuk.edu.tr

5558175133 ext. +90

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Other Identifiers

SelcukU_PT_MS_FIMT-IMT_Resp.01

Identifier Type: -

Identifier Source: org_study_id