HIT-Stroke Trial 2

NCT06268041 | Recruiting DMC

• 2 other identifiers: 427659R01HD093694
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

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

Keywords

gait; aerobic; locomotion

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Test Distance

  Total distance walked in 6 minutes in meters

  Change from Baseline to 12 weeks

Secondary Outcomes (6)

• 6-Minute Walk Test Distance

  Change from Baseline to 3 month follow up

• Self-Selected Gait Speed

  Change from Baseline to 12 weeks

• Fastest Gait Speed

  Change from Baseline to 12 weeks

• PROMIS-Fatigue Scale version 8a

  Change from Baseline to 3 month follow up

• Aerobic Capacity

  Change from Baseline to 12 weeks

Study Arms (2)

Moderate-Intensity Aerobic Training

ACTIVE COMPARATOR

Behavioral: Moderate-Intensity Aerobic Training

High-Intensity Interval Training

EXPERIMENTAL

Behavioral: High-Intensity Interval Training

Interventions

Moderate-Intensity Aerobic Training 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.

Moderate-Intensity Aerobic Training

High-Intensity Interval Training 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.

High-Intensity Interval Training

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Cincinnati: lead
• University of Kansas Medical Center: collaborator
• University of Delaware: collaborator

Study Sites (3)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40766122 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pierce Boyne, PT, DPT, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Nicoloff

CONTACT

513-558-7487; strokerecovery@uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: February 9, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be submitted within one year of trial completion and will remain available indefinitely
• Access Criteria: Established by the repository

Locations

US (3)