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Идёт набор NCT06554665

Powering Up Stroke Rehabilitation Through HIIT

Без фазы С лечением Stroke

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: High-intensity Interval Training, Moderate-Intensity Continuous Training, Stretching.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 50 лет — 80 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
Гонконг
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

Powering Up Stroke Rehabilitation Through High-Intensity Interval Training

Обзор

Objectives: To investigate the effects of high-intensity interval training (HIIT) on musculoskeletal fitness in chronic stroke survivors. Hypothesis to be tested: HIIT, performed on a recumbent stepper, will significantly enhance muscle power in chronic stroke survivors when compared with moderate-intensity continuous training (MICT) Design and subjects: Assessor-blinded, stratified, randomised, placebo-controlled clinical trial involving eligible 66 chronic stroke survivors. Interventions: Participants will be randomly allocated to one of three groups: the HIIT group, the MICT group, or a stretching group (active control). Each group will attend sessions three times per week for 12 consecutive weeks, totaling 36 training sessions. Main outcome measures: Assessments will be conducted at baseline, at mid-term of the intervention (week 6), at the end of the intervention (week 12), and at a 12-week follow-up (week 24). The primary outcome measure will be muscle power. Secondary outcome measures will include muscle strength, body composition, biomarkers, motor function, balance function, cardiorespiratory response, and psychosocial response.

Вмешательства

  • Поведенческое High-intensity Interval Training
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
  • Поведенческое Moderate-Intensity Continuous Training
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.
  • Поведенческое Stretching
    There will be three sessions per week for 12 consecutive weeks, totaling 36 training sessions.

Первичные конечные точки

  • Change from Baseline in Muscle Power at Week 12 [Срок оценки: Baseline and Week 12]
Вторичные конечные точки (12)
  • Change from Baseline in Muscle Power at Week 24 [Срок оценки: Baseline and Week 24]
  • Change from Baseline in Muscle Strength (Nm) at Week 12 [Срок оценки: Baseline and Week 12]
  • Change from Baseline in Muscle Strength (Nm) at Week 24 [Срок оценки: Baseline and Week 24]
  • Change from Baseline in Muscle Strength (kg) at Week 12 [Срок оценки: Baseline and Week 12]
  • Change from Baseline in Muscle Strength (kg) at Week 24 [Срок оценки: Baseline and Week 24]
  • Change from Baseline in Body Composition (kg) at Week 12 [Срок оценки: Baseline and Week 12]
  • Change from Baseline in Body Composition (kg) at Week 24 [Срок оценки: Baseline and Week 24]
  • Change from Baseline in Body Composition (%) at Week 12 [Срок оценки: Baseline and Week 12]
  • Change from Baseline in Body Composition (%) at Week 24 [Срок оценки: Baseline and Week 24]
  • Change from Baseline in Biomarkers at Week 12 [Срок оценки: Baseline and Week 12]
  • Change from Baseline in Biomarkers at Week 6 [Срок оценки: Baseline and Week 6]
  • Change from Baseline in Motor Function at Week 12 [Срок оценки: Baseline and Week 12]

Критерии участия

Критерии включения

  • Men and postmenopausal women aged 50-80 years
  • 1-5 years following the first-ever stroke confirmed by magnetic resonance imaging or computed tomography
  • Able to walk 10 meters independently with or without a walking aid
  • Class I or II according to the New York Heart Association Functional Classification (no limitation or slight limitation of physical activity due to symptoms during ordinary physical activity)

Критерии исключения

  • Presence of other neurological comorbidities, significant liver or renal diseases, thyroid or parathyroid diseases, rheumatoid arthritis, or a fracture within the past 6 months
  • Undergoing osteoporosis treatments within the past 3 years, use of oral corticosteroids for more than 3 months within the past year, or botulinum toxin injections in the paretic lower limb within the past 6 months
  • Participation in ongoing stroke rehabilitation services or structured exercise programme
  • Cognitive or communication issues that could limit the ability to follow instructions
  • Contraindications to HIIT, graded exercise testing, or failure to pass medical clearance from a specialist

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The Hong Kong Polytechnic University — Kowloon

Идентификаторы

NCT: NCT06554665 · HSEARS20230720002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗