Набор скоро начнётся NCT07578740

The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis High-intensity Interval Training Gait Balance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Moderate-Intensity Continuous Training (MICT), High-Intensity Interval Training (HIIT).
Кому может быть актуально: Состояния в реестре: Multiple Sclerosis, High-intensity Interval Training, Gait, Balance. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis

Обзор

This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.

Подробное описание

Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.

Вмешательства

Поведенческое Moderate-Intensity Continuous Training (MICT)
Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program.
Поведенческое High-Intensity Interval Training (HIIT)
Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: \~20 min, followed by 30-min individualized physiotherapy program.

Первичные конечные точки

Timed Up and Go Test (TUG) [Срок оценки: Baseline and 8 weeks]

Вторичные конечные точки (10)

Timed 25-Foot Walk Test (T25FW) [Срок оценки: Baseline and 8 weeks]
Dynamic Gait Index (DGI) [Срок оценки: Baseline and 8 weeks]
Incremental Shuttle Walk Test (ISWT) [Срок оценки: Baseline and 8 weeks]
Mini Balance Evaluation Systems Test (Mini-BESTest) [Срок оценки: Baseline and 8 weeks]
Modified CTSIB (mCTSIB) - Static Posturography [Срок оценки: Baseline and 8 weeks]
Serum BDNF levels (ELISA) [Срок оценки: Baseline and 8 weeks]
Serum VEGF levels (ELISA) [Срок оценки: Baseline and 8 weeks]
Symbol Digit Modalities Test (SDMT) [Срок оценки: Baseline and 8 weeks]
California Verbal Learning Test-II (CVLT-II) [Срок оценки: Baseline and 8 weeks]
Brief Visuospatial Memory Test-Revised (BVMT-R) [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
Age 18 years and older
EDSS score between 0 and 4
Score of 24 or above on the Standardized Mini Mental State Examination
No relapse in the past 3 months
Medically stable for at least 6 months