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Inspiratory Muscle Training in Individuals With Multiple Sclerosis

I

Istanbul University - Cerrahpasa

Status

Not yet enrolling

Conditions

Multiple Sclerosis
Inspiratory Muscle Training

Treatments

Behavioral: Conventional rehabilitation
Behavioral: Low intensity IMT
Behavioral: High intensity interval IMT

Study type

Interventional

Funder types

Other

Identifiers

NCT07672535
ZApaydın-1

Details and patient eligibility

About

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, characterized by inflammation, demyelination, and axonal degeneration, and primarily affects young adults. Muscle weakness, sensory disturbances, spasticity, pain, visual impairment, ataxia, fatigue, cognitive dysfunction, and respiratory complications are among the most commonly reported symptoms in individuals with MS. Although inspiratory muscle training has been shown to have beneficial effects in individuals with MS, the effects of different inspiratory muscle training intensities on respiratory muscle strength and pulmonary function have not been sufficiently investigated.

The primary aim of this study is to investigate the effectiveness and clinical feasibility of high-intensity interval inspiratory muscle training in individuals with MS. The secondary aim is to compare the effects of high-intensity interval inspiratory muscle training, low-intensity inspiratory muscle training, and conventional rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life in individuals with MS.

Participants will be randomly assigned to one of three groups: a high-intensity interval inspiratory muscle training group, a low-intensity inspiratory muscle training group, or a conventional rehabilitation group. All three groups will receive conventional rehabilitation, while the inspiratory muscle training groups will additionally receive their respective inspiratory muscle training programs. This study aims to be the first randomized controlled trial to evaluate the effects of high-intensity interval inspiratory muscle training in individuals with MS.

Full description

Multiple sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system. Although the pathogenesis of the disease is not fully understood, genetic and environmental factors are thought to contribute to its development. Demyelinating plaques, the primary pathological hallmark of MS, are most commonly found in the optic nerves, brainstem, spinal cord, and periventricular white matter. The clinical manifestations of the disease vary depending on the regions of the central nervous system affected and the extent of inflammation and axonal demyelination. Respiratory function and respiratory muscle strength have been shown to be lower in individuals with MS compared with healthy individuals. The risk of death due to respiratory complications is approximately 12 times higher in the MS population than in the general population, and 47% of MS-related deaths are attributed to respiratory complications. These findings highlight the critical importance of early interventions targeting respiratory function.

Although inspiratory muscle training (IMT) has been shown to improve respiratory function, its effects on functional outcomes in individuals with MS have not been sufficiently investigated. However, these functional outcomes are important for improving quality of life and optimizing rehabilitation in individuals with MS. Furthermore, because studies investigating IMT in individuals with MS are limited, the optimal training protocol in terms of training frequency, intensity, and duration has not yet been clearly established. Recent studies have demonstrated that high-intensity interval IMT is effective in improving respiratory function, respiratory muscle strength, and functional capacity in individuals with chronic obstructive pulmonary disease, bronchiectasis, and heart failure, and that it is well tolerated by patients. To the best of our knowledge, no study has investigated the effects of this approach in individuals with MS.

This study is designed as a randomized controlled trial. A total of 48 individuals diagnosed with MS will be randomly assigned to one of three groups: high-intensity interval IMT, low-intensity IMT, or conventional rehabilitation. The intervention period will last 8 weeks. All three groups will receive conventional rehabilitation consisting of aerobic and resistance exercises. In addition, the IMT groups will receive either high-intensity interval IMT or low-intensity IMT. The primary outcome measures of the study are respiratory muscle strength, pulmonary function, and cough strength. Secondary outcome measures include exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of multiple sclerosis (MS) according to the 2024 McDonald criteria
  • Expanded Disability Status Scale (EDSS) score ≥2 and <6
  • Age between 18 and 65 years
  • Mini-Mental State Examination (MMSE) score >24
  • Willingness to participate in the study

Exclusion criteria

  • Experiencing an MS relapse within the past three months
  • Presence of chronic cardiac or pulmonary diseases that may affect respiratory muscle strength and function, such as COPD, asthma, interstitial lung disease, or heart failure
  • Presence of pulmonary infection
  • Presence of orthopedic problems
  • Presence of psychiatric disorders
  • Pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 3 patient groups

High intensity interval IMT group
Experimental group
Description:
High-intensity interval IMT and conventional rehabilitation
Treatment:
Behavioral: High intensity interval IMT
Low intensity IMT group
Experimental group
Description:
Low intensity IMT and conventional rehabilitation
Treatment:
Behavioral: Low intensity IMT
Conventional rehabilitation
Active Comparator group
Description:
Conventional rehabilitation
Treatment:
Behavioral: Conventional rehabilitation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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