High Intensity Interval Training for People With Stroke Deficits (HIIT-Stroke)

May 5, 2023 updated by: Susan Marzolini, University Health Network, Toronto

High Intensity Interval Training for People With Stroke Deficits: Optimizing the Exercise Intervention (The HIIT-Stroke Study)

The purpose of this study is to compare the effects of an exercise training strategy called high-intensity interval training (HIIT) to moderate intensity continuous exercise (MICE), on walking function and cardiovascular fitness in stroke patients. Hypothesis: HIIT will result in significantly greater benefit to fitness and mobility than MICE.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Detailed Description

Using a randomized design, the study will evaluate the effects of 3 HIT sessions combined with 2 MICE sessions per week on cardiovascular fitness and mobility compared to MICE training 5 days/week. Participants post-stroke will be randomly assigned to either MICE (5 days per week (d∙wk-1)) or combined HIIT (3 d∙wk-1) with MICE (2 d∙wk-1). Both groups will be exercising 5 times per week (walking on a treadmill with harness for fall protection); 3 times at the centre and 2 times at home. Outcome measures will be conducted before and after 24 weeks of training.

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.
47

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 2V6
        • Toronto Rehabilitation Institute - Rumsey Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • clinical diagnosis of stroke (hemorrhagic or ischemic),
  • ability to walk at least 100 m independently with or without an assistive device with no severe limitations due to pain,
  • living in the community at least 10 weeks post stroke (no upper limit) with a stroke-related motor impairment score of <7 on the Chedoke-McMaster Stroke Assessment scale of the leg or foot or with hemiparetic gait pattern,
  • no severe communicative aphasia or comprehensive aphasia as noted in in clinical reports or referral form
  • no orthopedic issues that may be aggravated by HIT
  • ability to provide informed consent

Exclusion Criteria:

  • severe uncontrolled hypertension or orthostatic blood pressure decrease of >20 mmHg
  • other cardiovascular morbidities which would limit exercise tolerance (e.g. horizontal or downsloping ST-segment depression >2 mm, symptomatic aortic stenosis, complex arrhythmias),
  • unstable angina,
  • severe proliferative retinopathy or uncontrolled blood glucose,
  • hypertrophic cardiomyopathy
  • lower extremity claudication
  • cognitive and/or behavioral issues limiting participation in exercise testing and training, prior unrelated neurological disorders or psychiatric illness
  • abdominal or inguinal hernia causing discomfort with routine activities.

Other issues will be considered case-by-case.

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: None (Open Label)

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.
Experimental: High Intensity Training
High Intensity Interval Training patients will attend the centre 3 times/week for 24 weeks. All subjects will participate in MICE aerobic training 5 days/week in the first four weeks of the study to provide a foundation of fitness and endurance for the safe prescription of HIIT. Subsequently, the HIIT group will replace 3 MICE training days with 3 HIIT. HIIT sessions will include two 20 minute protocols; 30:60 second work:active rest ratio, and 120:180 second work:active rest ratio on a treadmill with a harness for fall protection. In addition to supervised exercise training (3 times/week), MICE will be conducted 2 times/week in the home/community, which has been shown to be both safe and effective
Behavioral: High Intensity Interval Training
Supervised HIIT sessions will be conducted on a treadmill at Toronto Rehab's Cardiac Rehabilitation and Secondary Prevention Program. During each of the three supervised HIIT sessions each week, subjects will be prescribed 2 protocols with a combination of short to moderate duration exercise of near maximal intensity alternating longer periods of active recovery. The total duration for each HIT session will be approximately 20 minutes with an additional 5 minutes warm-up and cool down period.
Other Names:
  • HIIT
Active Comparator: Moderate Intensity Exercise
Moderate Intensity Continuous Exercise patients will attend the centre 3 times/week for 24 weeks. Participants will be progressed to 30 to 60 minutes of continuous exercise at the heart rate that occurred at the anaerobic threshold on the exercise test. Participants will exercise on a treadmill with a harness ofr fall protection. In addition to supervised exercise training (3 times/week), MICE will be conducted 2 times/week in the home/community by both cohorts.
Behavioral: Moderate Intensity Continuous Exercise
MICE sessions represent the standard of care exercise prescription at TRI. Participants will be instructed to complete 20-60 minutes of continuous aerobic exercise at or around the ventilatory anaerobic threshold achieved on the cardiopulmonary exercise test.
Other Names:
  • Standard
  • MICE

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
Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
Time Frame: 0, 24 weeks
A symptom-limited exercise test will be performed on a treadmill with a harness for fall protection using a ramp protocol. Breath-by-breath gas samples will be collected via calibrated metabolic cart to determine peak oxygen uptake.
0, 24 weeks
Change in Six Minute Walk Test
Time Frame: 0, 24 weeks
This test measures the distance that an individual can quickly walk in a period of 6 minutes on a flat surface. Participants will complete one trial with the gait aide prescribed to them. The distance will be recorded. Participants can stop and rest or discontinue to the test at any time.
0, 24 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
Neuropsychological Test Battery (change over time)
Time Frame: 0, 24 weeks
Two executive function measures to measure selective attention and executive inhibition processes as well as a measure to assess speed of processing will be used. We will also include Trails A and B, DKEFS verbal fluency, the Weschsler digit symbol coding assessment.
0, 24 weeks
VO2 during HIT and MICE
Time Frame: 9 weeks and 24 weeks
To determine the ability of patients to reach critical intensity thresholds during HIT training and MICE and to examine dose-response associations, the acute effects (time spent above the critical intensity levels) will be measured using an ambulatory oxygen monitor. Ventilatory values will be measured using the CORTEX Biophysik MetaMax®3X portable gas analyzer recorded every 10 seconds for calculation of the time spent above the critical levels.
9 weeks and 24 weeks
Change in Dual task gait velocity
Time Frame: 0, 24 weeks
This assessment will include four 10 metre walking tasks at maximal comfortable speed. Three minutes after the first two 10 metre trials, participants will be asked to repeat the walk with simultaneous serial 3 subtractions and then naming as many words as possible that begin with a certain letter of the alphabet [FAS]. The number of errors and time to complete the tasks will be recorded.
0, 24 weeks
Adherence
Time Frame: 0 to 24 weeks
Attendance and completion of home-based sessions measured via exercise diary
0 to 24 weeks
Adverse Events
Time Frame: 0 to 24 weeks
Any adverse event or near miss is required to be reported as standard of care at Toronto Rehab/UHN.
0 to 24 weeks
Patient satisfaction
Time Frame: 24 weeks
questionnaire
24 weeks
Change in Brain Blood Flow response to exercise
Time Frame: 9 weeks and 24 weeks
Transcarnial Doppler ultrasound of the MCA and simultaneous finger cuff blood pressure monitoring during exercise
9 weeks and 24 weeks
Muscle Oxygenation
Time Frame: 0, 8 weeks, 12 weeks, 24 weeks
Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.
0, 8 weeks, 12 weeks, 24 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 Health Network, Toronto

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: Susan Marzolini, PhD, Toronto Rehabilitaiton Institute
  • Study Director: Paul Oh, MD, Toronto Rehabilitation Institute

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.
March 1, 2017

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.
July 31, 2022

Study Completion (Anticipated)

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.
August 31, 2023

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).
December 19, 2016

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.
December 27, 2016

First Posted (Estimate)

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.
December 30, 2016

Study Record Updates

Last Update Posted (Actual)

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.
May 9, 2023

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.
May 5, 2023

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.
May 1, 2023

More Information

Terms related to this study

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.
  • 16-5760-DE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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