Effect of High-Intensity Interval Training Intervention on Post-Stroke Fatigue in Chronic Stroke Survivors: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Eligibility rate (%)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Eligibility rate (%)
时间窗: Through study completion, an average of 12 weeks.
Compliance with HIIT (%)
时间窗: From baseline to week 12
Recruitment rate (number of participants per month)
时间窗: Through study completion, an average of 12 weeks.
Fidelity to the HIIT protocol (%)
时间窗: From baseline to week 12
Adverse events (number of events)
时间窗: From baseline to week 12
Retention of the intervention (%)
时间窗: From baseline to week 12
Acceptability (qualitative)
时间窗: At week 12
次要结局
- Multidimensional Fatigue Inventory (MDI)(Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.)
- Short Form-36 Health Survey (SF-36)(Blinded assessors will conduct evaluations at baseline, week 6, and week 12.)
- Fatigue Severity Scale (FSS)(Blinded assessors will conduct evaluations at baseline, week 12 , and week 20.)
- Inflammatory biomarkers(Blinded assessors will conduct evaluations at baseline, week 6, and week 12.)
研究者
Dr HUANG Mei Zhen
Assistant professor
The Hong Kong Polytechnic University