High Intensity Interval Training After Stroke

Study Overview
=================
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.

Official Title
-----------------
The Effect of High Intensity Interval Training on Maximal Oxygen Uptake and Risk Factors for Recurrent Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: High intensity interval training
* Behavioral: General information


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>Supervised high intensity interval training (uphill treadmill walking 4 x 4 min at 90-95% of peak heart rate) 3 times weekly for 8 weeks | Behavioral: High intensity interval training<br>* Uphill treadmill walking<br>|
| Other: standard care<br>Standard clinical follow-up care, including general information about importance of physical activity as part of a healthy lifestyle | Behavioral: General information<br>* Standard care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Oxygen Uptake | A graded treadmill test of maximal oxygen uptake using a breath by breath ergospirometer | 1 year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure (systolic and diastolic) | Blood pressure will be measured at rest | 8 weeks and 12 months after inclusion | 
| Walking speed | Walking speed (in minutes:seconds) will be measured with the 10 meter walk test and the Timed Up and Go test. | 8 weeks and 12 months after inclusion | 
| Leisure time activity and inactive time | Using the ActivePal monitor attached to the participants non-affected leg information on position, walking and inactive time will be measured during 3 whole consecutive days. | 8 weeks and 12 months after inclusion | 
| Balance tested with the Bergs Balance Test |  | 8 weeks and 12 months after inclusion | 
| Change in Blood tests | The following blood tests will be taken: Hemoglobin, HDL, LDL, Cholesterol, Total Cholesterol, C peptides, Triglycerides and HbA1c | 8 weeks and 12 months after inclusion | 
| Independence assessed by Functional Independence Measure (FIM) |  | 8 weeks and 12 months after inclusion | 
| Self reported physical activity level assessed by International Physical Activity Questionnaire |  | 8 weeks and 12 months after inclusion | 
| Cognitive function assessed by Montreal Cognitive Assessment and Trail Making A and B |  | 8 weeks and 12 months after inclusion | 
| Walking distance | Walking distance (in meters) will be measured with the 6 minute walk test. | 8 weeks and 12 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise training, Oxygen consumption