Recruiting

HIT-Stroke

Sponsor:

University of Cincinnati

Code:

NCT06268041

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Moderate-Intensity Aerobic Training

High-Intensity Interval Training

Study Details

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 ID

NCT06268041

Start date

Feb 9, 2024

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Moderate-Intensity Aerobic Training

experimental: High-Intensity Interval Training

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.

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.

Primary outcome measure

  • 6-Minute Walk Test Distance [ Time Frame: Change from Baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Audrey Nicoloff

513-558-7487strokerecovery@uc.edu

Locations

University of Delaware

Recruiting

Newark, Delaware, United States, 19713

Contacts

Jane Diehl

strokestudies@udel.edu

Principal Investigator:

Darcy Reisman, PT, PhD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Sasha Moores

913-588-2697reachlab@kumc.edu

Principal Investigator:

Sandra Billinger, PT, PhD

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Audrey Nicoloff

513-558-7487strokerecovery@uc.udu

More Information

Sponsor

University of Cincinnati

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • gait
  • aerobic
  • locomotion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-05-01.