NCT05936008CompletedPhase 2
Fitness After Stroke Trial
Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 19 Jun 2023
- Start date
- 3 Jul 2023
- Primary completion date
- 8 Dec 2025
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Stroke
- NCT number
- NCT05936008
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 59
- From 3 Jul 2023 to the primary completion date, 8 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes
Other illness
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Recent history (\<3 months) of illicit drug or alcohol abuse or diagnosis of significant mental illness
- Major post-stroke depression (Patient Health Questionnaire, PHQ-9 ≥ 1084)
- Other significant neurologic, orthopedic or peripheral vascular conditions that would limit exercise participation
- Oxygen-dependent chronic obstructive pulmonary disease
- Diagnosis of other neurological disease (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease)
Other
- 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
- Self report pregnancy
Who the study is looking for
- 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
Age in the registry: 20 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.