Comparison of the Effects of High-Intensity and Low-Intensity Inspiratory Muscle Training in Individuals With Multiple Sclerosis

Not yet recruitingNot a drug-phase studyMS (type not specified)NCT07672535

What it found

Still running

No result yet.

What was tested

Treatment tested

  • High intensity interval IMT
  • Low intensity IMT

Compared with

  • Conventional rehabilitation

What it measured

Main measures

  • Maximal inspiratory pressure (MIP)

    From baseline to the end of the intervention at 8 weeks

    Physical function
  • Maximal expiratory pressure (MEP)

    From baseline to the end of the intervention at 8 weeks

    Physical functionNerve conduction tests
  • Forced Vital Capacity (FVC)

    From baseline to the end of the intervention at 8 weeks

  • Forced Expiratory Volume (FEV1)

    From baseline to the end of the intervention at 8 weeks

  • Tiffeneau Index (FEV1/FVC)

    From baseline to the end of the intervention at 8 weeks

  • Peak Expiratory Flow (PEF)

    From baseline to the end of the intervention at 8 weeks

  • Cough strength

    From baseline to the end of the intervention at 8 weeks

    Physical function

Other measures (7)

  • Exercise capacity

    From baseline to the end of the intervention at 8 weeks

    Walking and mobilityPhysical function
  • Lower Extremity Functional Capacity

    From baseline to the end of the intervention at 8 weeks

  • Balance

    From baseline to the end of the intervention at 8 weeks

    Walking and mobility
  • Fatigue level

    From baseline to the end of the intervention at 8 weeks

    Fatigue
  • Dysphagia severity

    From baseline to the end of the intervention at 8 weeks

  • Sleep quality

    From baseline to the end of the intervention at 8 weeks

    Mood and sleep
  • The Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    From baseline to the end of the intervention at 8 weeks

    Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Aug 2026

    2. Main results due

      Aug 2027

    3. Finished

      Jan 2028

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