Clinical trial NCT02550015: High Intensity Interval Training After Stroke
Official title: The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Exercise training
Oxygen consumption
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if high intensity interval training after stroke is more effective than standard care to increase maximal oxygen uptake, reduce known risk factors for recurrent stroke and improve function.

Detailed description: Stroke is a leading cause of adult disability. Well designed studies have shown that the majority of the stroke population have low aerobic capacity and many are inactive. This is negative for their health and well-being. Physical inactivity may increase their risk of having recurrent stroke.

The optimal training mode and intensity to improve aerobic capacity after stroke are not clear. High intensity interval training (ie. 90-95% of peak heart rate) has been proven to be more beneficial than moderate and low intensity exercise in order to improve maximal oxygen uptake in patients with cardiac disease. The response from this training on aerobic capacity and physical function in the stroke population are not known.

Eligibility criteria: Inclusion Criteria:

* Approved informed consent
* Independent walking \> 2 minutes
* First episode of stroke (ischemic or hemorrhagic)
* Minimum 3 months post-stroke
* Living in the community and able to travel to assessment and training site
* Approval to participate from the study's responsible medical doctor
* Modified Rankin Scale 0-3

Exclusion Criteria:

* Impaired cognitive function to give valid informed consent to participate
* Instability of cardiac conditions (ie. serious rhythm disorder, valve malfunction)
* Other conditions where test of maximal oxygen uptake is contraindicated
* Poorly controlled hypertension (\>180/100), measured at rest
* \> 5 years post stroke
* Subarachnoid hemorrhage
* Participating in other ongoing intervention study
* Other serious illness influencing testing of cardiorespiratory fitness and function at 1 year follow-up

Primary outcomes:
measure: Maximal Oxygen Uptake
timeFrame: 1 year after inclusion
Secondary outcomes:
measure: Change in blood pressure (systolic and diastolic)
timeFrame: 8 weeks and 12 months after inclusion
measure: Walking speed
timeFrame: 8 weeks and 12 months after inclusion
measure: Leisure time activity and inactive time
timeFrame: 8 weeks and 12 months after inclusion
measure: Balance tested with the Bergs Balance Test
timeFrame: 8 weeks and 12 months after inclusion
measure: Change in Blood tests
timeFrame: 8 weeks and 12 months after inclusion
measure: Independence assessed by Functional Independence Measure (FIM)
timeFrame: 8 weeks and 12 months after inclusion
measure: Self reported physical activity level assessed by International Physical Activity Questionnaire
timeFrame: 8 weeks and 12 months after inclusion
measure: Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B
timeFrame: 8 weeks and 12 months after inclusion
measure: Walking distance
timeFrame: 8 weeks and 12 months after inclusion
Other outcomes:
measure: New cardiovascular or cerebrovascular incidents
timeFrame: 8 weeks and 12 months after inclusion
measure: Severity of stroke
timeFrame: 8 weeks and 12 months after inclusion
measure: Anxiety and depression after stroke
timeFrame: 8 weeks and 12 months after inclusion
measure: Degree of disability and dependence
timeFrame: 8 weeks and 12 months after inclusion
measure: Health status assessed by The Norwegian version of EQ-5D-5L questionnaire
timeFrame: 8 weeks and 12 months after inclusion
measure: Submaximal oxygen consumption during treadmill walking
timeFrame: 8 weeks and 12 months after inclusion
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience
Study officials:
affiliation: Norwegian University of Science and Technology
name: Torunn Askim, phd
role: STUDY_DIRECTOR
References:
citation: Gjellesvik TI, Becker F, Tjonna AE, Indredavik B, Nilsen H, Brurok B, Torhaug T, Busuladzic M, Lydersen S, Askim T. Effects of High-Intensity Interval Training After Stroke (the HIIT-Stroke Study): A Multicenter Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jun;101(6):939-947. doi: 10.1016/j.apmr.2020.02.006. Epub 2020 Mar 4.