High Intensity Interval Training for People With Stroke Deficits

Stroke Clinical Trial

— HIIT-Stroke  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03006731
• Other study ID #: 16-5760-DE
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute - Rumsey Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Neuropsychological Test Battery (change over time)	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
Secondary	VO2 during HIT and MICE	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
Secondary	Change in Dual task gait velocity	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
Secondary	Adherence	Attendance and completion of home-based sessions measured via exercise diary	0 to 24 weeks
Secondary	Adverse Events	Any adverse event or near miss is required to be reported as standard of care at Toronto Rehab/UHN.	0 to 24 weeks
Secondary	Patient satisfaction	questionnaire	24 weeks
Secondary	Change in Brain Blood Flow response to exercise	Transcarnial Doppler ultrasound of the MCA and simultaneous finger cuff blood pressure monitoring during exercise	9 weeks and 24 weeks
Secondary	Muscle Oxygenation	Near Infrared Spectroscopy (NIRS) measurement of the vastus lateralis during rest and exercise.	0, 8 weeks, 12 weeks, 24 weeks