High Intensity Interval Training for People With Stroke Deficits

NCT03006731 | Unknown

• 1 other identifier: 16-5760-DE
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Change in Cardiovascular fitness - Peak oxygen uptake (VO2peak)

  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

  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 Outcomes (8)

• Neuropsychological Test Battery (change over time)

  0, 24 weeks

• VO2 during HIT and MICE

  9 weeks and 24 weeks

• Change in Dual task gait velocity

  0, 24 weeks

• Adherence

  0 to 24 weeks

• Adverse Events

  0 to 24 weeks

Study Arms (2)

High Intensity Training

EXPERIMENTAL

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

Moderate Intensity Exercise

ACTIVE COMPARATOR

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

Interventions

High Intensity Interval Training BEHAVIORAL

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.

Also known as: HIIT

High Intensity Training

Moderate Intensity Continuous Exercise BEHAVIORAL

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.

Also known as: MICE, Standard

Moderate Intensity Exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Rehabilitation Institute - Rumsey Centre

Toronto, Ontario, M4G 2V6, Canada

Location

Related Publications (1)

• Marzolini S, Robertson AD, MacIntosh BJ, Corbett D, Anderson ND, Brooks D, Koblinsky N, Oh P. Effect of High-Intensity Interval Training and Moderate-Intensity Continuous Training in People With Poststroke Gait Dysfunction: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Nov 21;12(22):e031532. doi: 10.1161/JAHA.123.031532. Epub 2023 Nov 10.

  PMID: 37947080 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susan Marzolini, PhD

  Toronto Rehabilitaiton Institute

  PRINCIPAL INVESTIGATOR

• Paul Oh, MD

  Toronto Rehabilitation Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the outcome assessor is blinded for the cardiopulmonary exercise stress test but not for the 6-minute walk test.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 30, 2016
• Study Start: March 1, 2017
• Primary Completion: July 31, 2022
• Study Completion: August 31, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)