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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.
People with stroke often experience physical decline and aerobic fitness that can be reversed through exercise. Evidence has shown that participating in exercise benefits aerobic fitness and vascular health while less is known about brain health. However, the optimal exercise dose such as intensity and exercise type (continuous, interval) are not yet known.
The long-term goal of this project is to develop and test strategies to be implemented in larger clinical trials to improve health in people living with stroke. For this preliminary efficacy trial, the Investigator will enroll 50 participants with chronic stroke, age 20-85 years, into a 4-week exercise program. Participants will be allocated to one of the following groups using minimization, a type of randomization based on the lower extremity Fugl-Meyer score: 1) moderate intensity continuous training (MICT), that serves as the control, or 2) high-intensity interval training (HIIT). Exercise will be performed on a recumbent stepper. The Investigator will: Assess the preliminary efficacy of HIIT on aerobic fitness (Aim 1), cerebrovascular hemodynamics (Aim 2), and vascular function (Aim 3).
Current exercise recommendations for stroke use general exercise prescription principles for older adults and are not grounded on data generated from large, well-designed, randomized controlled trials in stroke. If aerobic exercise could be proven to reduce the number of "years of life lived with disability," it would offer a key strategy for: 1) minimizing dependence on caregiver support, 2) reducing overall healthcare costs, and 3) extending quality of life for individuals after stroke. This proposed trial will address an important gap in knowledge for both the scientific and clinical communities and provide essential data that will contribute to future exercise prescription recommendations focused on stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate intensity, continuous training (MICT) | Active Comparator | After a 5-minute warm-up at 30% peak watts, MICT will consist of continuous exercise for 25 minutes at 55% of peak watts (range: 45%-65%). The average heart rate for each individual session should not exceed 70% (60-70%) of HR maximum to align with current exercise recommendations for stroke. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. |
|
| High intensity, interval exercise (HIIT) | Active Comparator | After the 5-minute warm-up at 30% peak watts, HIIT will consist of repeated 1-minute, high intensity bursts ("on" interval) alternated with 1-minute interval recovery ("off" interval) for 25 minutes. The "on" interval will begin at 70% of peak watts (range: 65%-95%) followed by the "off" interval at 10% of peak watts. The average HR for the "on" intervals will not exceed 85% age predicted maximum (75-85%). There will be 13 minutes of "on" and 12 minutes of "off" interval exercise. An active cool-down (20% peak workload) at comfortable stepping pace occurs immediately after the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise MICT | Behavioral | Standard of care, exercise recommendations for people with stroke |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen uptake (VO2) | Assessing change in oxygen uptake during a submaximal exercise test | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Middle cerebral artery velocity | Assessing change in middle cerebral artery velocity response to an acute exercise bout | Baseline, 4 weeks |
| Middle cerebral artery velocity at rest | Assessing change in middle cerebral artery velocity during a rest condition |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test (6MWT) | Walking endurance using the 6MWT | Baseline, 4 weeks |
| 10-Meter Walk Test | Gait speed using the 10-Meter Walk Test | Baseline, 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra A Billinger, PhD | KU Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42239661 | Derived | Bartsch BL, Britton-Carpenter AJ, Engler A, Baldridge T, Moores A, Hazen EM, Montgomery RN, Billinger SA. Fitness After Stroke Trial (FAST): Protocol for a Preliminary Efficacy Study of Recumbent Stepper High-Intensity Interval Training. Artery Res. 2026;32(1):12. doi: 10.1007/s44200-026-00104-3. Epub 2026 Jun 1. | |
| 41891032 | Derived |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The Investigator will use an adaptive randomization design called minimization to ensure balance across groups. Intervention arms include:
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Outcome assessors will be blinded to the participant's intervention group. Participants will not be given detailed information about the exercise groups.
| Exercise HIIT | Behavioral | The HIIT protocol consists of Short Interval, High Volume exercise at 1-minute exercise bouts followed by 1-minute active recovery for 25 minutes. |
|
|
| Baseline, 4 weeks |
| Flow-mediated Dilation | Endothelial vascular function | Baseline, 4 weeks |
| Pulse Wave Velocity | Arterial stiffness | Baseline, 4 weeks |
| Cerebral Blood Flow | Global and regional blood flow using MRI | Baseline, 4 weeks |
| Bartsch BL, Engler A, Schneider N, Britton-Carpenter AJ, Baldridge T, Montgomery RN, Vidoni ED, Moores A, Vetter ES, Hazen EM, Abraham M, Billinger SA. Submaximal Exercise Testing to Dose High-Intensity Interval Training After Stroke: The FAST Randomized Clinical Trial. medRxiv [Preprint]. 2026 Mar 19:2026.03.17.26348646. doi: 10.64898/2026.03.17.26348646. |
| 41510301 | Derived | Bartsch BL, Britton-Carpenter AJ, Engler A, Baldridge T, Moores A, Hazen EM, Montgomery RN, Billinger SA. Fitness After Stroke Trial (FAST): Protocol for a Preliminary Efficacy Study of Recumbent Stepper High-Intensity Interval Training. Res Sq [Preprint]. 2025 Dec 22:rs.3.rs-8264290. doi: 10.21203/rs.3.rs-8264290/v1. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |