HIT-Stroke Trial 2 (HST2)

April 27, 2026 updated by: Pierce Boyne, University of Cincinnati

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke: HIT-Stroke Trial 2

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • University of Delaware
        • Contact:
        • Principal Investigator:
          • Darcy Reisman, PT, PhD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Sandra Billinger, PT, PhD
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate-Intensity Aerobic Training
Behavioral: 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.
Experimental: High-Intensity Interval Training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test Distance
Time Frame: Change from Baseline to 12 weeks
Total distance walked in 6 minutes in meters
Change from Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-Minute Walk Test Distance
Time Frame: Change from Baseline to 3 month follow up
Total distance walked in 6 minutes in meters
Change from Baseline to 3 month follow up
Self-Selected Gait Speed
Time Frame: Change from Baseline to 12 weeks
From 10-meter walk test at self-selected speed, in meters per second
Change from Baseline to 12 weeks
Fastest Gait Speed
Time Frame: Change from Baseline to 12 weeks
From 10-meter walk test at fastest speed, in meters per second
Change from Baseline to 12 weeks
PROMIS-Fatigue Scale version 8a
Time Frame: Change from Baseline to 3 month follow up
An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5. Items are combined to obtain a total T score, where higher scores indicate greater fatigue.
Change from Baseline to 3 month follow up
Aerobic Capacity
Time Frame: Change from Baseline to 12 weeks
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 12 weeks
EuroQol-5D-5L
Time Frame: Change from Baseline to 3 month follow up
A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total 'misery score' will be calculated by averaging the scores for each item.
Change from Baseline to 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kansas Medical Center
University of Delaware

Investigators

  • Principal Investigator: Pierce Boyne, PT, DPT, PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 427659
  • R01HD093694 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final, de-identified dataset and data documentation will be deposited into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive

IPD Sharing Time Frame

Will be submitted within one year of trial completion and will remain available indefinitely

IPD Sharing Access Criteria

Established by the repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Moderate-Intensity Aerobic Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe