HIT-Stroke Trial 2

NCT ID: NCT06268041

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2028-04-30

Brief Summary

People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Moderate-Intensity Aerobic Training

Group Type: ACTIVE_COMPARATOR

Moderate-Intensity Aerobic Training

Intervention Type: BEHAVIORAL

Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.

High-Intensity Interval Training

Group Type: EXPERIMENTAL

High-Intensity Interval Training

Intervention Type: BEHAVIORAL

Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.

Interventions

Moderate-Intensity Aerobic Training

Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.

Intervention Type: BEHAVIORAL

High-Intensity Interval Training

Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 30-85 years at time of consenting
• Hemiparesis from ischemic and/or hemorrhagic strokes
• Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
• Walking speed <1.0 m/s on the 10-meter walk test
• Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
• Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
• Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents)
• Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria

• Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
• Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
• Hospitalization for cardiac or pulmonary disease within past 3 months
• Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
• Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
• Severe lower limb spasticity (Ashworth >2)
• Known recent history (<3 months) of unstable substance abuse or unstable mental illness
• Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
• Currently participating in physical therapy or another interventional study targeting walking function
• Recent (<2 weeks) or planned changes in lower limb orthotic or spasticity management
• Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
• Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
• Unable to walk outside the home prior to stroke
• Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
• Pregnancy
• Previous exposure to fast treadmill walking (>3 cumulative hours) in the past year

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Pierce Boyne

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierce Boyne, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Delaware

Newark, Delaware, United States

Site Status: RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Madison Yeazell

Role: CONTACT

strokerecovery@uc.edu

513-558-7487

Facility Contacts

Jane Diehl

Role: primary

strokestudies@udel.edu

Sasha Moores

Role: primary

reachlab@kumc.edu

913-588-2697

Madison Yeazell

Role: primary

strokerecovery@uc.udu

513-558-7487

References

Garrity C, Reisman DS, Billinger SA, Pressler D, Wagner E, Awosika O, Bartsch BL, Briton-Carpenter A, Carl D, Engler A, Foster J, Kim J, McCartney K, Moores A, Sucharew H, Thompson E, Walters K, Wasik E, Wright H, Yeazell M, Boyne P. Protocol for the HIT-Stroke Trial 2 randomized controlled trial: Moderate-intensity exercise versus high-intensity interval training to determine the optimal training intensity for walking rehabilitation in chronic stroke. medRxiv [Preprint]. 2025 Jul 31:2025.07.30.25332470. doi: 10.1101/2025.07.30.25332470.

Reference Type: DERIVED

PMID: 40766122 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01HD093694

Identifier Type: NIH

Identifier Source: secondary_id

View Link

427659

Identifier Type: -

Identifier Source: org_study_id