Fitness After Stroke Trial (NCT05936008) | Clinical Trial Compass
CompletedPhase 2
Fitness After Stroke Trial
United States59 participantsStarted 2023-07-03
Plain-language summary
People living with stroke have very low aerobic fitness, which can negatively impact brain health. Identifying the best exercise which includes exercise stimulus type (interval, continuous) or intensity, how hard to exercise (moderate, high) that benefit aerobic fitness, vascular health, and the brain's main blood vessels after stroke are unknown. This study is designed to determine the preliminary efficacy of high-volume HIIT to moderate intensity exercise using a seated stepper exercise device that allows the arms and legs to move back and forth.
Who can participate
Age range
20 Years – 85 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:
* Both sexes between the age of 20-85 years at time of consent
* Chronic ischemic or hemorrhagic stroke 6 months to 15 years at consent. People with stroke and newly diagnosed cardiovascular complications had \>50% prevalence of recurrent stroke at 5 years. Index stroke or recurrent stroke on same side as index stroke will be allowed.
* Ability to walk over ground with assistive devices and no continuous physical assistance from another person to perform tests for gait speed and six-minute walk test
* Exercise continuously for minimum of 30 watts for 3 minutes on the recumbent stepper to demonstrate ability to perform the exercise test.
* No aerobic exercise contraindications or other safety/physical concerns during the submaximal exercise test.
* Able to communicate with investigators, follow 2-step command \& correctly answer consent comprehension questions
* Currently participating in less than 150 minutes of physical activity/week assessed by the Rapid Assessment of Physical Activity
* Stable blood pressure \& statin medication doses for 30 days prior to enrollment due to effects on vascular health/hemodynamics
Exclusion Criteria:
* Hospitalization for cardiac or pulmonary disease within past 3 months
* Implanted pacemaker or defibrillator limiting exercise performance
* Reported pain that limits or interferes with activities of daily living and physical activity/exercise
* Severe LE spasticity (Ashworth \>2) due to inability to exercise
* Recent hi…
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.