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

March 24, 2025 updated by: Pierce Boyne, University of Cincinnati
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 40-80 years at time of consenting
  2. Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
  3. Walking speed <1.0 m/s on the 10-meter walk test
  4. 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)
  5. Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
  6. Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 metabolic equivalents)
  7. Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria:

  1. 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)
  2. 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
  3. Hospitalization for cardiac or pulmonary disease within past 3 months
  4. Implanted pacemaker or defibrillator
  5. Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  6. Severe lower limb spasticity (Ashworth >2)
  7. Recent history (<3 months) of illicit drug or alcohol abuse or significant mental illness
  8. Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
  9. Currently participating in physical therapy or another interventional study
  10. 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
  11. Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
  12. Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
  13. 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)
  14. Pregnancy
  15. Previous exposure to fast treadmill walking (>3 cumulative hours) during clinical or research therapy 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change Six-Minute Walk Test Distance from Baseline to 4 Weeks
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
Change Six-Minute Walk Test Distance from Baseline to 8 Weeks
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
Change Six-Minute Walk Test Distance from Baseline to 12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comfortable Gait Speed
Time Frame: Change from Baseline to 4 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 4 Weeks
Comfortable Gait Speed
Time Frame: Change from Baseline to 8 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 8 Weeks
Comfortable Gait Speed
Time Frame: Change from Baseline to 12 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 12 Weeks
Fast Gait Speed
Time Frame: Change from Baseline to 4 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 4 Weeks
Fast Gait Speed
Time Frame: Change from Baseline to 8 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 8 Weeks
Fast Gait Speed
Time Frame: Change from Baseline to 12 Weeks
From 10-meter walk test, in meters per second
Change from Baseline to 12 Weeks
Aerobic Fitness
Time Frame: Change from Baseline to 4 Weeks
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 4 Weeks
Aerobic Fitness
Time Frame: Change from Baseline to 8 Weeks
Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 8 Weeks
Aerobic Fitness
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
PROMIS-Fatigue Scale
Time Frame: Change from Baseline to 4 Weeks
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.
Change from Baseline to 4 Weeks
PROMIS-Fatigue Scale
Time Frame: Change from Baseline to 8 Weeks
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.
Change from Baseline to 8 Weeks
PROMIS-Fatigue Scale
Time Frame: Change from Baseline to 12 Weeks
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.
Change from Baseline to 12 Weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: Change from Baseline to 4 Weeks
Time to exhaustion during treadmill graded exercise test, recorded in minutes
Change from Baseline to 4 Weeks
Exercise Capacity
Time Frame: Change from Baseline to 8 Weeks
Time to exhaustion during treadmill graded exercise test, recorded in minutes
Change from Baseline to 8 Weeks
Exercise Capacity
Time Frame: Change from Baseline to 12 Weeks
Time to exhaustion during treadmill graded exercise test, recorded in minutes
Change from Baseline to 12 Weeks
Peak Oxygen Consumption Rate
Time Frame: Change from Baseline to 4 Weeks
Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 4 Weeks
Peak Oxygen Consumption Rate
Time Frame: Change from Baseline to 8 Weeks
Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 8 Weeks
Peak Oxygen Consumption Rate
Time Frame: Change from Baseline to 12 Weeks
Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute
Change from Baseline to 12 Weeks
Metabolic Cost of Gait
Time Frame: Change from Baseline to 4 Weeks
Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter
Change from Baseline to 4 Weeks
Metabolic Cost of Gait
Time Frame: Change from Baseline to 8 Weeks
Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter
Change from Baseline to 8 Weeks
Metabolic Cost of Gait
Time Frame: Change from Baseline to 12 Weeks
Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter
Change from Baseline to 12 Weeks
EuroQol 5D-5L (EQ-5D-5L)
Time Frame: Change from Baseline to 4 Weeks
A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).
Change from Baseline to 4 Weeks
EuroQol 5D-5L (EQ-5D-5L)
Time Frame: Change from Baseline to 8 Weeks
A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).
Change from Baseline to 8 Weeks
EuroQol 5D-5L (EQ-5D-5L)
Time Frame: Change from Baseline to 12 Weeks
A 5-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total misery score was calculated by summing the scores for each item (min 5, max 25).
Change from Baseline to 12 Weeks
Activities-specific Balance Confidence Scale
Time Frame: Change from Baseline to 4 Weeks
A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.
Change from Baseline to 4 Weeks
Activities-specific Balance Confidence Scale
Time Frame: Change from Baseline to 8 Weeks
A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.
Change from Baseline to 8 Weeks
Activities-specific Balance Confidence Scale
Time Frame: Change from Baseline to 12 Weeks
A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score from 0-100 is calculated by averaging the scores for each item.
Change from Baseline to 12 Weeks
Daily Walking Activity
Time Frame: Change from Baseline to 4 Weeks
Mean daily step count recorded with activity monitor, recorded as steps per day
Change from Baseline to 4 Weeks
Daily Walking Activity
Time Frame: Change from Baseline to 8 Weeks
Mean daily step count recorded with activity monitor, recorded as steps per day
Change from Baseline to 8 Weeks
Daily Walking Activity
Time Frame: Change from Baseline to 12 Weeks
Mean daily step count recorded with activity monitor, recorded as steps per day
Change from Baseline to 12 Weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Kansas Medical Center
Children's Hospital Medical Center, Cincinnati
University of Delaware

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierce Boyne, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-5325
  • R01HD093694 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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)

IPD Sharing Time Frame

Data are available now and should remain available indefinitely.

IPD Sharing Access Criteria

Established by the repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: 424597

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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