Fitness After Stroke Trial

NCT05936008 | Completed Phase 2

• 1 other identifier: STUDY00147598
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Keywords

exercise; cerebrovascular; cardiovascular; walking; aerobic fitness; brain

Outcome Measures

Primary Outcomes (1)

• Oxygen uptake (VO2)

  Assessing change in oxygen uptake during a submaximal exercise test

  Baseline, 4 weeks

Secondary Outcomes (4)

• Middle cerebral artery velocity

  Baseline, 4 weeks

• Middle cerebral artery velocity at rest

  Baseline, 4 weeks

• Flow-mediated Dilation

  Baseline, 4 weeks

• Pulse Wave Velocity

  Baseline, 4 weeks

Other Outcomes (3)

• 6-Minute Walk Test (6MWT)

  Baseline, 4 weeks

• 10-Meter Walk Test

  Baseline, 4 weeks

• Cerebral Blood Flow

  Baseline, 4 weeks

Study Arms (2)

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.

Behavioral: Exercise MICT

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.

Behavioral: Exercise HIIT

Interventions

Exercise MICT BEHAVIORAL

Standard of care, exercise recommendations for people with stroke

Also known as: aerobic exercise

Moderate intensity, continuous training (MICT)

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.

Also known as: HIIT, aerobic exercise, anaerobic exercise

High intensity, interval exercise (HIIT)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• 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.

  PMID: 41891032 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.

  PMID: 41510301 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sandra A Billinger, PhD

  KU Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the participant's intervention group. Participants will not be given detailed information about the exercise groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chair, Stroke Translational Research

Model Details: 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

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 7, 2023
• Study Start: July 3, 2023
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: January 6, 2026

Record last verified: 2024-08

Locations

US (1)