Effect of HIIT on Post-Stroke Fatigue (NCT07273058) | Clinical Trial Compass
RecruitingNot Applicable
Effect of HIIT on Post-Stroke Fatigue
Hong Kong60 participantsStarted 2025-10-15
Plain-language summary
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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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.
Exclusion criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eligibility rate (%)
Timeframe: Through study completion, an average of 12 weeks.
2
Recruitment rate (number of participants per month)
Timeframe: Through study completion, an average of 12 weeks.