Exercise program for improving fitness after stroke
Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study
This study is testing whether a high-intensity exercise program can help stroke survivors improve their fitness and heart health better than a moderate exercise program.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 85 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT05936008 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of high-intensity interval training (HIIT) compared to moderate intensity continuous training (MICT) in improving aerobic fitness and vascular health in individuals who have experienced a stroke. Participants aged 20-85 with chronic stroke will engage in a 4-week exercise program using a recumbent stepper. The study will assess the impact of these exercise modalities on aerobic fitness, cerebrovascular health, and vascular function. The findings could inform future larger trials aimed at enhancing health outcomes for stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20-85 who have experienced a chronic ischemic or hemorrhagic stroke and can perform basic exercise tasks.
Not a fit: Patients who are unable to engage in any form of aerobic exercise or have contraindications to exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise recommendations that enhance aerobic fitness and overall health for stroke survivors.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in stroke rehabilitation, but this specific approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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) * Currently participating in physical therapy targeting lower extremity function or another interventional study that may influence study outcomes * 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) * Self report pregnancy
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Sandra A Billinger, PhD — KU Medical Center
- Study coordinator: Sandra A Billinger, PhD
- Email: sbillinger@kumc.edu
- Phone: 913-945-6685
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.