Effect of HIIT on Post-Stroke Fatigue

Официальное название

Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial

Обзор

This study aims to investigate the effect of high-intensity interval training (HIIT) on fatigue severity among individuals with chronic stroke. Participants will be randomly assigned to the HIIT group, the moderate-intensity continuous training (MICT) group, or the stretching group (active control). Each group will participate in supervised exercise sessions three times per week over a 12-week period, totaling 36 sessions. Outcome assessments will be conducted at baseline, mid-intervention (week 6), post-intervention (week 12), and follow-up (week 20). The primary outcome will be fatigue severity. Secondary outcomes will include inflammatory biomarkers and additional health-related indicators.

Вмешательства

• Поведенческое HIIT
  The HIIT intervention will consist of a 3-minute warm-up, a 25-minute main exercise, and a 2-minute cool-down. The main exercise will include four 4-minute high-intensity intervals, each interspersed with a 3-minute low-intensity recovery period. Participants will attend three supervised sessions per week over a 12-week period.
• Поведенческое MICT
  The MICT intervention will include a 3-minute warm-up, 25 minutes of continuous exercise performed at a moderate intensity, and a 2-minute cool-down. Participants will attend three supervised sessions per week over a 12-week period.
• Поведенческое stretching
  The stretching intervention will consist of 30 minutes of whole-body stretching. Participants will attend three sessions per week over a 12-week period.

Первичные конечные точки

• Eligibility rate (%) [Срок оценки: Through study completion, an average of 12 weeks.]
• Recruitment rate (number of participants per month) [Срок оценки: Through study completion, an average of 12 weeks.]
• Compliance with HIIT (%) [Срок оценки: From baseline to week 12]
• Fidelity to the HIIT protocol (%) [Срок оценки: From baseline to week 12]
• Retention of the intervention (%) [Срок оценки: From baseline to week 12]
• Adverse events (number of events) [Срок оценки: From baseline to week 12]
• Acceptability (qualitative) [Срок оценки: At week 12]

Вторичные конечные точки (4)

• Fatigue Severity Scale (FSS) [Срок оценки: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.]
• Multidimensional Fatigue Inventory (MDI) [Срок оценки: Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.]
• Short Form-36 Health Survey (SF-36) [Срок оценки: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.]
• Inflammatory biomarkers [Срок оценки: Blinded assessors will conduct evaluations at baseline, week 6, and week 12.]

Критерии участия

Критерии включения

• Age of 40-80 years;
• a history of ischemic stroke resulting in unilateral limb impairment 6-60 months prior to consent to participate in the pilot trial;
• a stable medical condition;
• a subjective feeling of fatigue, defined as a period of apparent fatigue, decreased energy, increased need for rest, or fatigue out of proportion to physical activity for at least 2 weeks during the past month;
• ability to communicate with the investigators and lack of significant cognitive deficits;
• able to walk for 10 meters with or without a walking aid.

Критерии исключения

• An FSS score of < 4 (20);
• other neurological conditions;
• other musculoskeletal comorbidities that would prevent safe participation in exercises;
• a medical diagnosis of significant cardiovascular, pulmonary, or metabolic disease(s);
• signs or symptoms indicative of significant cardiovascular, pulmonary, or metabolic disease(s) during the previous 3 months;
• severe lower limb spasticity (Ashworth Scale score ≥ 3);
• Botulinum toxin use in the affected lower limb within the past six months;
• current or previous use of drugs intended to resolve post-stroke fatigue;
• active engagement in other stroke rehabilitation trials.

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: NCT07273058 · HSEARS20241002001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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