StrokeNCT03760016

Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke

A study testing Moderate-Intensity Aerobic Training and High-Intensity Interval Training in people with Stroke, run by University of Cincinnati at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Stroke
What is being tested?: Moderate-Intensity Aerobic Training and High-Intensity Interval Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 3 sitesUnited States
Study dates: 4 Jan 2019to 25 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 40-80 years at time of consenting
Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
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

Who cannot join

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)
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
Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
Severe lower limb spasticity (Ashworth >2)

Show all 15Show fewer

Recent history (<3 months) of illicit drug or alcohol abuse or significant 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
Recent botulinum toxin injection to the paretic lower limb (<3 months) or planning to have lower limb botulinum toxin injection in the next 4 months
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
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) during clinical or research therapy in the past year

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Cincinnati
Cincinnati, Ohio, 45267
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Delaware
Newark, Delaware, 19713

Other trials in United States

About this study

The objective of this study is to determine the optimal training intensity and the minimum training duration needed to maximize immediate improvements in walking capacity in chronic stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up to 36 total sessions over approximately 12 weeks. Clinical measures of walking function, aerobic fitness, daily walking activity and quality of life will be assessed at baseline (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).

Conditions: Stroke
Being tested: Moderate-Intensity Aerobic Training, High-Intensity Interval Training
Keywords: Rehabilitation, Locomotion, Aerobic, Intensity, Dosing
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moderate-Intensity Aerobic TrainingBehavioural
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 TrainingBehavioural
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.

Study groups in NCT03760016
Study group	Role	What they receive
Moderate-Intensity Aerobic Training	Active comparator	Not described Receives: Behavioral: Moderate-Intensity Aerobic Training
High-Intensity Interval Training	Experimental	Not described Receives: Behavioral: High-Intensity Interval Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Measured: Change Six-Minute Walk Test Distance from Baseline to 4 Weeks
Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Measured: Change Six-Minute Walk Test Distance from Baseline to 8 Weeks
Six-Minute Walk Test Distance
Total distance walked in 6 minutes in meters
Measured: Change Six-Minute Walk Test Distance from Baseline to 12 Weeks

Secondary outcomes (12)

Comfortable Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 4 Weeks
Comfortable Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 8 Weeks
Comfortable Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 12 Weeks
Fast Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 4 Weeks
Fast Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 8 Weeks
Fast Gait Speed
From 10-meter walk test, in meters per second
Measured: Change from Baseline to 12 Weeks
Aerobic Fitness
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Measured: Change from Baseline to 4 Weeks
Aerobic Fitness
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Measured: Change from Baseline to 8 Weeks
Aerobic Fitness
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Measured: Change from Baseline to 12 Weeks
PROMIS-Fatigue Scale
The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.
Measured: Change from Baseline to 4 Weeks
PROMIS-Fatigue Scale
The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.
Measured: Change from Baseline to 8 Weeks
PROMIS-Fatigue Scale
The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale is an 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total raw score is calculated by summing the scores for each item. The raw score is then translated into a T-score based on normative data. The T-score is a standardized score with a mean of 50 and a standard deviation of 10 for the U.S. general population, so a T-score of 60 (for example) would represent one SD higher (worse) fatigue than the average American.
Measured: Change from Baseline to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 201925 Apr 2022

First posted30 Nov 2018
Study start4 Jan 2019
Primary completion25 Apr 2022
Study completion25 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03760016
Sponsor's protocol ID: 2017-5325
Other IDs: R01HD093694
Status last verified: Mar 2025
First submitted: 26 Nov 2018
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We deposited the final, de-identified dataset and data documentation into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive (URL below)

Publications

Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033.
PubMed 36822187
Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040.
PubMed 42064927
Boyne P, Miller A, Schwab-Farrell SM, Sucharew H, Carl D, Billinger SA, Reisman DS. Training Parameters and Adaptations That Mediate Walking Capacity Gains from High-Intensity Gait Training Poststroke. Med Sci Sports Exerc. 2025 Jul 1;57(7):1285-1296. doi: 10.1249/MSS.0000000000003691. Epub 2025 Mar 3.
PubMed 40025665
Palmer JA, Whitaker AA, Payne AM, Bartsch BL, Reisman DS, Boyne PE, Billinger SA. Aerobic Exercise Improves Cortical Inhibitory Function After Stroke: A Preliminary Investigation. J Neurol Phys Ther. 2024 Apr 1;48(2):83-93. doi: 10.1097/NPT.0000000000000453. Epub 2023 Jul 10.
PubMed 37436187
Miller A, Reisman DS, Billinger SA, Dunning K, Doren S, Ward J, Wright H, Wagner E, Carl D, Gerson M, Awosika O, Khoury J, Kissela B, Boyne P. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Trials. 2021 Jul 16;22(1):457. doi: 10.1186/s13063-021-05419-x.
PubMed 34271979

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke
ClinicalTrials.gov ID: NCT03760016
Acronym / sponsor ID: 2017-5325
Conditions: Stroke
Keywords: Rehabilitation, Locomotion, Aerobic, Intensity, Dosing
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Collaborators: University of Delaware, University of Kansas Medical Center, Children's Hospital Medical Center, Cincinnati, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 4 Jan 2019 (actual)
Primary completion: 25 Apr 2022 (actual)
Study completion: 25 Apr 2022 (actual)
First posted: 30 Nov 2018 (actual)
Results: Posted 20 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Moderate-Intensity Aerobic Training	Active comparator	Behavioral: Moderate-Intensity Aerobic Training
High-Intensity Interval Training	Experimental	Behavioral: High-Intensity Interval Training

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 40-80 years at time of consenting
Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
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)

Key exclusion criteria (15 listed)

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)
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
Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moderate-Intensity Aerobic TrainingOverground 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.	Behavioural	Moderate-Intensity Aerobic Training
High-Intensity Interval TrainingOverground 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.	Behavioural	High-Intensity Interval Training

Primary outcome

Six-Minute Walk Test Distance
Time frame: Change Six-Minute Walk Test Distance from Baseline to 4 Weeks
Total distance walked in 6 minutes in meters
Six-Minute Walk Test Distance
Time frame: Change Six-Minute Walk Test Distance from Baseline to 8 Weeks
Total distance walked in 6 minutes in meters
Six-Minute Walk Test Distance
Time frame: Change Six-Minute Walk Test Distance from Baseline to 12 Weeks
Total distance walked in 6 minutes in meters

12 secondary outcomes

Comfortable Gait Speed
Time frame: Change from Baseline to 4 Weeks
Comfortable Gait Speed
Time frame: Change from Baseline to 8 Weeks
Comfortable Gait Speed
Time frame: Change from Baseline to 12 Weeks
Fast Gait Speed
Time frame: Change from Baseline to 4 Weeks
Fast Gait Speed
Time frame: Change from Baseline to 8 Weeks
Fast Gait Speed
Time frame: Change from Baseline to 12 Weeks
Aerobic Fitness
Time frame: Change from Baseline to 4 Weeks
Aerobic Fitness
Time frame: Change from Baseline to 8 Weeks
Aerobic Fitness
Time frame: Change from Baseline to 12 Weeks
PROMIS-Fatigue Scale
Time frame: Change from Baseline to 4 Weeks
PROMIS-Fatigue Scale
Time frame: Change from Baseline to 8 Weeks
PROMIS-Fatigue Scale
Time frame: Change from Baseline to 12 Weeks

Results and safety

Results posted to the registry on 20 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-Intensity Interval Training	27	19
Moderate-Intensity Aerobic Training	28	23

Primary outcome: Six-Minute Walk Test Distance

Time frame: Change Six-Minute Walk Test Distance from Baseline to 4 Weeks. Least squares mean (95% Confidence Interval). Unit: meters

Measure	High-Intensity Interval Training n = 27	Moderate-Intensity Aerobic Training n = 28
Value	27 (6 to 48)	12 (-9 to 33)

Population analysed: Results are from an intent-to-treat analysis using a linear mixed effects model that included all available time points (Baseline, 4-week, 8-week and 12-week) for all randomized participants and estimated contrasts for change from baseline to each time point. Missing data were handled with the maximum likelihood method.

Primary outcome: Six-Minute Walk Test Distance

Time frame: Change Six-Minute Walk Test Distance from Baseline to 8 Weeks. Least squares mean (95% Confidence Interval). Unit: meters

Measure	High-Intensity Interval Training n = 27	Moderate-Intensity Aerobic Training n = 28
Value	58 (39 to 76)	29 (9 to 48)

Primary outcome: Six-Minute Walk Test Distance

Time frame: Change Six-Minute Walk Test Distance from Baseline to 12 Weeks. Least squares mean (95% Confidence Interval). Unit: meters

Measure	High-Intensity Interval Training n = 27	Moderate-Intensity Aerobic Training n = 28
Value	71 (49 to 94)	27 (3 to 50)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of participant enrollment post-randomization, which was approximately 4 months for participants who completed the study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-Intensity Interval Training	1 of 27 (3.7%)	13 of 27 (48.1%)	0 of 27
Moderate-Intensity Aerobic Training	3 of 28 (10.7%)	10 of 28 (35.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36822187Boyne P, Billinger SA, Reisman DS, Awosika OO, Buckley S, Burson J, Carl D, DeLange M, Doren S, Earnest M, Gerson M, Henry M, Horning A, Khoury JC, Kissela BM, Laughlin A, McCartney K, McQuaid T, Miller A, Moores A, Palmer JA, Sucharew H, Thompson ED, Wagner E, Ward J, Wasik EP, Whitaker AA, Wright H, Dunning K. Optimal Intensity and Duration of Walking Rehabilitation in Patients With Chronic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Apr 1;80(4):342-351. doi: 10.1001/jamaneurol.2023.0033.
Derived from this study: PubMed 42064927Pressler D, Schwab-Farrell SM, Awosika OO, Reisman DS, Billinger SA, Riley MA, Boyne P. Predicting Musculoskeletal Adverse Events During Moderate- to High-Intensity Walking Training in Chronic Stroke. medRxiv [Preprint]. 2026 Apr 18:2026.04.16.26351040. doi: 10.64898/2026.04.16.26351040.
Derived from this study: PubMed 40025665Boyne P, Miller A, Schwab-Farrell SM, Sucharew H, Carl D, Billinger SA, Reisman DS. Training Parameters and Adaptations That Mediate Walking Capacity Gains from High-Intensity Gait Training Poststroke. Med Sci Sports Exerc. 2025 Jul 1;57(7):1285-1296. doi: 10.1249/MSS.0000000000003691. Epub 2025 Mar 3.
Derived from this study: PubMed 37436187Palmer JA, Whitaker AA, Payne AM, Bartsch BL, Reisman DS, Boyne PE, Billinger SA. Aerobic Exercise Improves Cortical Inhibitory Function After Stroke: A Preliminary Investigation. J Neurol Phys Ther. 2024 Apr 1;48(2):83-93. doi: 10.1097/NPT.0000000000000453. Epub 2023 Jul 10.
Derived from this study: PubMed 34271979Miller A, Reisman DS, Billinger SA, Dunning K, Doren S, Ward J, Wright H, Wagner E, Carl D, Gerson M, Awosika O, Khoury J, Kissela B, Boyne P. Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial. Trials. 2021 Jul 16;22(1):457. doi: 10.1186/s13063-021-05419-x.
Individual participant dataSharing planned: Yes. We deposited the final, de-identified dataset and data documentation into the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH) archive (URL below)

Related trials for Stroke

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierce Boyne, DPT, PhD principal investigator

University of Cincinnati

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Moderate-Intensity Aerobic Training and High-Intensity Interval Training in people with Stroke, run by University of Cincinnati at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-Minute Walk Test Distance (time frame: Change Six-Minute Walk Test Distance from Baseline to 4 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03760016, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.