Biomarkers of Reaction To HIIT Exercise (NCT06059872) | Clinical Trial Compass
RecruitingNot Applicable
Biomarkers of Reaction To HIIT Exercise
United States55 participantsStarted 2024-01-01
Plain-language summary
Stroke survivors with lower limb disability can improve their walking speed with high-intensity interval training (HIIT) rehabilitation therapy. However, some individuals may not respond to HIIT even when fully adherent to the program. To address this, the investigators propose to build a predictive model that identifies if a Veteran with chronic subcortical stroke will improve their walking speed with HIIT by incorporating blood lactate as an early predictor of exercise response, and inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and regional cerebral blood flow (CBF) as predictors of the brain's potential to respond, while also taking into consideration other factors such as comorbidities, demographics, and fitness levels.
Who can participate
Age range
18 Years – 89 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:
* chronic left or right subcortical stroke as defined by 6 months or more after a cardiovascular accident
* lower extremity motor impairment due to stroke that causes a walking speed of less than 0.6 m/s during a 10m walk
* Veteran status
Exclusion Criteria:
* MRI contraindications, including implanted cardiac pacemakers and severe claustrophobia
* any neurodegenerative condition other than stroke that may lead to lower extremity impairment
* a visual or auditory impairment that may hinder study procedures
* any medical condition that would preclude participation in a physical exercise intervention program
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
10 m walk test on a GAITRite mat
Timeframe: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)
2
Timed-Up-and-Go (TUG) test
Timeframe: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)
3
6-minute walk test
Timeframe: baseline (week 1) and after the completion of 12 weeks of exercise (week 14)