Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

Study Overview
=================
Brief Summary
-----------------
In a randomized controlled trial the effect of 12 weeks of cross-sectorial physical exercise combined with patient education and individual follow-up session is investigated in patients with minor stroke or non-disabling stroke.

Detailed Description
-----------------
Hypertension and physical inactivity are the most common risk factors for stroke. Patients with minor stroke or transient ischemic attack (TIA) have short-lasting symptoms, often with remission within hours or days. Though patients experience a quick remission, they have an increased risk of a recurrent stroke and progressive cognitive dysfunction. The patients are also likely to have other disposing risk factors such as diabetes, smoking, and hypercholesterolemia which may increase the risk of a recurrent stroke. Following hospital discharge, the patients are offered preventive medication, but no standardized rehabilitation or exercise. Previous studies have shown that physical exercise decreases cardiovascular risk factors for patients after stroke and increases physical function and quality of life. The aim is to develop and evaluate a standardized exercise program (a stroke school) for patients with minor stroke or TIA. The intervention consist of 6 weeks of supervised aerobic exercise at the hospital combined with patient education including knowledge on stroke risk factors. Subsequently, 6 weeks of supervised aerobic exercise in their local municipality. After the 12 weeks of exercise, patients are offered individual, motivational follow-up sessions with the purpose to facilitate the patients to stay physically active in their everyday life. This intervention will increase the patients´ knowledge regarding risk factors for stroke and cardiovascular disease, increase their cardiorespiratory fitness and facilitate the patients to be physical active and hopefully slow the progression of vascular disease.

Official Title
-----------------
Stroke School - Cross-sectorial Physical Exercise for Patients With Minor Stroke or Non-disabling Stroke

Conditions
-----------------
Minor Stroke, Non-disabling Stroke, Transient Ischemic Attack

Intervention / Treatment
-----------------
* Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a minor stroke or TIA without the need of rehabilitation after hospital discharge, but need physical activity in order to prevent cardiovascular diseases Patients spending ≤ 5 hour of leisure time on high-intensity physical activity on weekly basis within the last 3 months Able to speak and read Danish and to provide informed consent Individuals ≥ 18 years of age Exclusion Criteria: Previous large-artery stroke or hemorrhagic stroke Unstable cardiac condition, e.g. pacemaker Uncontrolled hypertension (patients not responding adequately to antihypertensive medication when applying treatment according to guidelines) Symptoms or comorbidities not allowing exercise on a stationary bicycle (e.g. claudication) Dyspnoea caused by heart or pulmonary disease (e.g. COPD) Aphasia, or dementia that interferer with understanding the protocol and/or physical examinations. Patients diagnosed with dementia at hospital admission (a score ≤23/30 on the Mini-Mental State Examination are not invited into the study)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise<br>12 weeks of supervised cardiorespiratory exercise twice a week (6 weeks at the hospital and 6 weeks in the local municipality) combined with patient education and individual follow-up sessions | Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions<br>* 6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality. Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life<br>|
| No Intervention: Usual care<br>The usual care group is encouraged to perform home-based aerobic exercise on their own | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months | A sub-maximal exercise test on a stationary bicycle where the workload increases by 15 Watts (W) every minute and each minute the patient recites a standardized text passage. When the patient is no longer able to speak comfortably the test terminates. The higher score the better cardiorespiratory fitness | from baseline to 3 months (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity Scale | A questionnaire measuring number of hours of self-reported physical activity during daily living. It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading. Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time. | from baseline to 3 months (post-intervention) | 
| Change in Physical Activity Scale from baseline to 12-months post-stroke | A questionnaire measuring number of hours of self-reported physical activity during daily living. It reveals daily time spent on sleep, sitting down at work, standing/walking at work, heavy physical work during working hours, active commuting to/from work, and sedentary behavior, including television watching and reading. Additionally, the patients record the weekly time spent on light-intensity, moderate-intensity, and vigorous-intensity activity during leisure time. | From baseline to 12-months post-stroke | 
| Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke | A maximal exercise test on a stationary bicycle | from baseline to 3 months (post-intervention) | 
| Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke | A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being | from baseline to 3 months (post-intervention) | 
| Change in The WHO-5 Well-being index from baseline to 12-months post-stroke | A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being | From baseline to 12-months post-stroke | 
| Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke | A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function | from baseline to 3 months (post-intervention) | 
| Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke | A cognitive screening test for detection of mild cognitive impairments, the score ranges from 0-30 points and a high score indicates better cognitive function | From baseline to 12-months post-stroke | 
| Change in Beck Depression Inventory from baseline to 3 months post-stroke | A self-report mood questionnaire. The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms | from baseline to 3 months (post-intervention) | 
| Change in Beck Depression Inventory from baseline 12-months post-stroke | A self-report mood questionnaire. The total score ranges from 0-63 points, and a high total score indicates more severe depressive symptoms | From baseline 12-months post-stroke | 
| Change in Fatigue Severity Scale from baseline to 3 months post-stroke | A 20-item self-report instrument designed to measure fatigue. The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue | from baseline to 3 months (post-intervention) | 
| Change in Fatigue Severity Scale from baseline to 12-months post-stroke | A 20-item self-report instrument designed to measure fatigue. The score ranges from 9-63 points, and a higher score indicates greater severity of fatigue | From baseline to 12-months post-stroke | 
| Change in blood pressure from baseline to 3 months post-stroke | Assessment of blood pressure (systolic and diastolic) | from baseline to 3 months (post-intervention) | 
| Change in blood pressure from baseline to 12-months post-stroke | Assessment of blood pressure (systolic and diastolic) | From baseline to 12-months post-stroke | 
| Change in body mass index from baseline to 3 months post-stroke | Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2). | from baseline to 3 months (post-intervention) | 
| Change in body mass index from baseline to 12-months post-stroke | Measures of weight in kilograms, and height in meters will be aggregated to arrive at one reported value, the body mass index (kg/m^2). | From baseline to 12-months post-stroke | 
| Change in Modified rankin scale from baseline to 3 months post-stroke | A measurement of symptoms/motor function. The score ranges from 0-6 points, where 0 represents no symptoms at all and 6 points represents dead. | from baseline to 3 months (post-intervention) | 
| Change in Modified rankin scale from baseline to 12-months post-stroke | A measurement of symptoms/motor function. The score ranges from 0-6 points, where 0 represents no symptoms at all and 6 points represents dead. | From baseline to 12-months post-stroke | 
| Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke | Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L). | from baseline to 3 months (post-intervention) | 
| Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke | Blood samples to evaluate degree of inflammation (low risk: < 1 mg/L, average risk: 1-3 mg/L, and high risk: >3 mg/L). | From baseline to 12-months post-stroke | 
| Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke | Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL) | from baseline to 3 months (post-intervention) | 
| Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke | Blood samples to evaluate cardiac function (normal: < 125 pg/mL, critical value: > 400 pg/mL) | From baseline to 12-months post-stroke | 
| Change in Cathepsin B from baseline to 3 months post-stroke | Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function) | from baseline to 3 months (post-intervention) | 
| Change in Cathepsin B from baseline to 12-months post-stroke | Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function) | From baseline to 12-months post-stroke | 
| Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke | detection of number of new infarcts or white matter lesions | From baseline to 12-months post-stroke | 
| Change in outcome expectancy for exercise-2 scale from baseline to 3 months post-stroke | A questionnaire measuring self-efficacy for exercise. The total score consist of two subscales; a postive and a negative. The positive subscale ranges from 1-5, and a higher positive sub-score indicates stronger/more positive outcome expectations for exercise, and the negative subscale ranges from 1-4, and a higher negative sub-score indicates more negative outcome expectations for exercise. | from baseline to 3 months (post-intervention) | 
| Change in outcome expectancy for exercise-2 scale from baseline to 12-months post-stroke | A questionnaire measuring self-efficacy for exercise. The total score consist of two subscales; a postive and a negative. The positive subscale ranges from 1-5, and a higher positive sub-score indicates stronger/more positive outcome expectations for exercise, and the negative subscale ranges from 1-4, and a higher negative sub-score indicates more negative outcome expectations for exercise. | From baseline to 12-months post-stroke | 
| Change in the Stages of exercise behavior change from baseline to 3 months post-stroke | A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance). Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups | from baseline to 3 months (post-intervention) | 
| Change in the Stages of exercise behavior change from baseline to 12-months post-stroke | A questionnaire consisting of six categories describing differerent stages towards exercise behavior change, ranking from no intention to change behavior (precontemplation) to sustain behavior change (maintenance). Data will be analysed by calculating the number of patients (percentage) in each category and with a comparison between groups | From baseline to 12-months post-stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minor stroke, Stroke prevention, Physical exercise, Patient education, Cardiorespiratory fitness, Non-disabling stroke