High Intensity Interval Training for Stroke

N/A
Waitlist Available
Led By Susan Marzolini, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up0, 8 weeks, 12 weeks, 24 weeks
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will compare the effects of two different types of exercise on walking ability and cardiovascular fitness in stroke patients. HIIT is hypothesized to result in greater benefit than MICE.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with a stroke, whether it's caused by bleeding or blockage of blood vessels.
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You can walk at least 100 meters by yourself or with a device without having extreme pain that limits your movement.
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You have had a stroke more than 10 weeks ago and have difficulty moving your leg or foot, or have a certain type of abnormal walking pattern due to the stroke.
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You do not have a severe language impairment that may affect communication, as noted in clinical reports or referral form.
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You do not have any bone or joint problems that may get worse due to the study.
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You need to fully understand and agree to participate in the study before you can take part.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 8 weeks, 12 weeks, 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 8 weeks, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)
Change in Six Minute Walk Test
Secondary outcome measures
Adherence
Adverse Events
Change in Brain Blood Flow response to exercise
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Intensity TrainingExperimental Treatment1 Intervention
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
Group II: Moderate Intensity ExerciseActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Intensity Interval Training
2013
N/A
~1140

Find a site

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,420 Previous Clinical Trials
482,163 Total Patients Enrolled
23 Trials studying Stroke
5,300 Patients Enrolled for Stroke
Susan Marzolini, PhDPrincipal Investigator
Toronto Rehabilitaiton Institute
Paul Oh, MDStudy Director
Toronto Rehabilitation Institute
5 Previous Clinical Trials
392 Total Patients Enrolled
1 Trials studying Stroke
43 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are accepted into this research experiment?

"Affirmative. The details posted on clinicaltrials.gov indicate that this medical trial is actively recruiting participants. It was first published in March of 2017 and modified most recently on January 14th 2020, with the need for 104 patients from a single site being specified."

Answered by AI

Are there any vacancies for participation in this experiment?

"Affirmative, the material on clinicaltrials.gov reveals that this medical experiment is actively searching for participants. It was initially posted on March 1st 2017 and amended most recently on January 14th 2020 with a need to enlist 104 patients at one single site."

Answered by AI

What are the core goals of this clinical examination?

"The primary aim of this trial, to be measured after 0 and 24 weeks, is the alteration in cardiovascular fitness as calculated by peak oxygen uptake (VO2peak). Secondary objectives entail a determination of patients' ability to reach intensity thresholds during HIT training and MICE using an ambulatory oxygen monitor; ventilatory values assessed with CORTEX Biophysik MetaMax®3X portable gas analysis every 10 seconds; changes over time via two executive function measures for selective attention and inhibition processes alongside speed-of-processing tests such as Trails A/B, DKEFS verbal fluency assessments, and Weschsler digit symbol coding."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
High Intensity Interval Training for People With Stroke Deficits
Susan Marzolini 2017. "High Intensity Interval Training for People With Stroke Deficits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03006731.
~6 spots leftby Oct 2024
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