The Effect of Aerobic Exercise in Patients With Lacunar Stroke

Study Overview
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Brief Summary
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In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.

Detailed Description
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Little is known about effect of exercise for patients with lacunar stroke, no studies have investigated the feasibility or effect of aerobic exercise in this subgroup of stroke. The patients have few and temporary symptoms and are therefore early discharged from the hospital. After an cerebral infarct the patients have increased risk of recurrent stroke and they are at risk of developing cognitive deficits or vascular dementia over time. Researchers want to investigate if high-intensity training at home in the acute phase has an effect on aerobic fitness, endothelial response and health profile in this potential fragile group of patients. We hope to increase the patients´ physical and mental function, and thereby prevent a recurrent stroke and slow the progression of vascular diseases.

Official Title
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High-intensity Training in Patients With Lacunar Stroke (HITPALS)

Conditions
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Stroke, Lacunar

Intervention / Treatment
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* Other: High-intensity training
* Drug: prophylactic stroke medication
* Behavioral: Recommendations for lifestyle changes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lacunar stroke verified by clinical examination and CT- or MRI-scans able to speak and read Danish Exclusion Criteria: previous large artery stroke, symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling, dyspnoea caused by heart or pulmonary disease, aphasia or dementia which hinder completion of the Talk Test. Amendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days). Also, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI. Amendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Prophylactic stroke medication and recommendations for lifestyle changes | Drug: prophylactic stroke medication<br>* Usual care medication for stroke prophylaxis<br>Behavioral: Recommendations for lifestyle changes<br>* Advise on diet, alcohol, smoking and exercise<br>|
| Active Comparator: Exercise<br>Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks | Other: High-intensity training<br>* high intensity training 5 days a week for 12 weeks<br>Drug: prophylactic stroke medication<br>* Usual care medication for stroke prophylaxis<br>Behavioral: Recommendations for lifestyle changes<br>* Advise on diet, alcohol, smoking and exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the 'Graded Cycling Test with Talk Test' | Sub-maximal exercise test on a stationary bicycle | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial response | measurement of endothelial response by Endopat2000 | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Physical Activity Scale (PAS) | A questionnaire that measures the level of self-reported physical activity | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Short time activity measurements | Accelerometer (Axivity) to short time registration of physical activity (24 hours in an 8 day period (after inclusion, before 3 months visit, before 12 month visit) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| The WHO-five Well-being Index (WHO-5) | A questionnaire that measures current mental well-being | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Montreal Cognitive Assessment (MOCA) | A cognitive screening test for detection of mild cognitive impairments | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Major Depression Inventory (MDI) | A self-report mood questionnaire | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Multidimensional Fatigue Inventory (MFI-20) | A 20-item self-report instrument designed to measure fatigue. | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Ull-Meter | An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress. | At baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Blood samples | Blood samples to determine cardiovascular risk factors | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 
| Magnetic resonance Imaging (MRI) | Detection of new infarcts or white matter lesions | 12 months after baseline testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, stroke, acute, Cerebral small vessel disease