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StrokePhase 2FASTNCT05936008

Fitness After Stroke Trial

A Phase 2 study testing Exercise MICT and Exercise HIIT in people with Stroke and Stroke, Ischemic, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?
Exercise MICT and Exercise HIIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
3 Jul 2023to 8 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

Official title: Investigating Exercise Prescription Parameters on Aerobic Fitness and Vascular Health After Stroke: A Pilot Study

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.

Read the detailed description

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.

Being tested
Exercise MICT, Exercise HIIT
Keywords
exercise, cerebrovascular, cardiovascular, walking, aerobic fitness, brain
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise MICTBehavioural

    Also called aerobic exercise

    Standard of care, exercise recommendations for people with stroke

  • Exercise HIITBehavioural

    Also called HIIT, aerobic exercise, anaerobic exercise

    The HIIT protocol consists of Short Interval, High Volume exercise at 1-minute exercise bouts followed by 1-minute active recovery for 25 minutes.

Study groups in NCT05936008
Study groupRoleWhat they receive
Moderate intensity, continuous training (MICT)Active comparatorAfter 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.
Receives: Behavioral: Exercise MICT
High intensity, interval exercise (HIIT)Active comparatorAfter 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.
Receives: Behavioral: Exercise HIIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen uptake (VO2)

    Assessing change in oxygen uptake during a submaximal exercise test

    Measured: Baseline, 4 weeks

Secondary outcomes (4)

  1. Middle cerebral artery velocity

    Assessing change in middle cerebral artery velocity response to an acute exercise bout

    Measured: Baseline, 4 weeks

  2. Middle cerebral artery velocity at rest

    Assessing change in middle cerebral artery velocity during a rest condition

    Measured: Baseline, 4 weeks

  3. Flow-mediated Dilation

    Endothelial vascular function

    Measured: Baseline, 4 weeks

  4. Pulse Wave Velocity

    Arterial stiffness

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start3 Jul 2023
  3. Primary completion8 Dec 2025
  4. Study completion8 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Investigator will use an adaptive randomization design called minimization to ensure balance across groups. Intervention arms include: 1. Moderate intensity, continuous training exercise 2. High intensity, interval training exercise
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05936008
Sponsor's protocol ID
STUDY00147598
Acronym
FAST
Status last verified
Aug 2024
First submitted
19 Jun 2023
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 42239661

  • 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.

    PubMed 41891032

  • 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.

    PubMed 41510301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exercise MICT and Exercise HIIT in people with Stroke and Stroke, Ischemic, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen uptake (VO2) (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05936008, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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