Effects of high-intensity multimodal functional training on motor and cognitive functions in people with multiple sclerosis: A study protocol of a pilot randomized controlled trial

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Objective: Multiple sclerosis (MS) is a chronic neurological condition causing motor and cognitive impairments. Evidence indicates that multimodal rehabilitation, including high-intensity interval training (HIIT), balance, and strength exercises can improve balance, walking ability, and cognition while reducing fatigue in People with MS (PwMS). This study aims to evaluate the effects of high-intensity multimodal functional training on improvements in balance, walking, and cognitive function and fatigue reduction in PwMS. Materials and Methods: This pilot randomized controlled, assessor-blinded, multicenter trial will include PwMS with an Expanded Disability Status Scale score ≥ 2 and ≤ 5.5 points. Participants will be randomized to an experimental group receiving high-intensity multimodal training (aerobic HIIT, balance, and strength exercises) or a control group (conventional rehabilitation). The intervention will consist of 16 sessions over 8 weeks. Participants will undergo an extensive evaluation at baseline (T0), post-intervention (T1), and after 2 months at the follow-up (T2). The assessment will include a fatiguing walking test, standing balance evaluation, and cognitive performance tests. Primary outcomes will focus on walking velocity during a fatiguing walking test, while secondary outcomes will evaluate balance, fatigue, and cognitive functions using wearable sensors and clinical scales. Results: Expected results will be a higher effect on walking (primary outcome), balance, fatigue, and cognition (secondary outcomes) for the experimental group (high-intensity multimodal functional training) compared to the control group (conventional rehabilitation). Conclusion: This study introduces a time-efficient, high-intensity multimodal rehabilitation protocol targeting motor and non-motor symptoms in PwMS. By promoting neuroplasticity, the intervention could enhance independence, quality of life, and inform future rehabilitation strategies for MS.

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