NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Istanbul University - Cerrahpasa
Conditions: Multiple Sclerosis, Inspiratory Muscle Training
Interventions: High intensity interval IMT, Low intensity IMT, Conventional rehabilitation
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.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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