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

Not Applicable

Recruiting

• Conditions: Non-disabling Stroke; Transient Ischemic Attack; Minor Stroke
• Interventions: Behavioral: Cardiorespiratory exercise combined with patient education and individual follow-up sessions

• Registration Number: NCT04945174
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Study Start: 2022-06-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2028-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Cardiorespiratory exercise combined with patient education and individual follow-up sessions	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

Primary Outcome Measures

Name	Time	Method
Change in 'the Graded Cycling Test with Talk Test' from baseline to 3 months	from baseline to 3 months (post-intervention)	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

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	Assessment of blood pressure (systolic and diastolic)
Change in Anxiety and depression from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	This is a self-reported questionnaire that measures anxiety and depression. A total score of 0-21 points is possible, with a higher score indicating more severe symptoms of depression or anxiety.
Change in blood pressure from baseline to 12-months post-stroke	From baseline to 12-months post-stroke	Assessment of blood pressure (systolic and diastolic)
Change in body mass index from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	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).
Change in body mass index from baseline to 12-months post-stroke	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).
Change in Modified rankin scale from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	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".
Change in Modified rankin scale from baseline to 12-months post-stroke	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".
Change in high-sensitivity C-reactive protein from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	Blood samples to evaluate degree of inflammation (low risk: \< 1 mg/L, average risk: 1-3 mg/L, and high risk: \>3 mg/L).
Change in high-sensitivity C-reactive protein from baseline to 12-months post-stroke	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).
Change in Pro brain natriuretic peptid from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	Blood samples to evaluate cardiac function (normal: \< 125 pg/mL, critical value: \> 400 pg/mL)
Change in Pro brain natriuretic peptid from baseline to 12-months post-stroke	From baseline to 12-months post-stroke	Blood samples to evaluate cardiac function (normal: \< 125 pg/mL, critical value: \> 400 pg/mL)
Change in Cathepsin B from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Change in Cathepsin B from baseline to 12-months post-stroke	From baseline to 12-months post-stroke	Blood samples to evaluate muscle protein. (high level of Cathepsin B may associate to improve cognitive function)
Change in Magnetic Resonance Imaging from baseline to 12-months post-stroke	From baseline to 12-months post-stroke	detection of number of new infarcts or white matter lesions
Change in Anxiety and depression from baseline 12-months post-stroke	From baseline 12-months post-stroke	This is a self-reported questionnaire that measures anxiety and depression. A total score of 0-21 points is possible, with a higher score indicating more severe symptoms of depression or anxiety.
Change in Fatigue Severity Scale from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	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
Change in The WHO-5 Well-being index from baseline to to 3 months post-stroke	from baseline to 3 months (post-intervention)	A questionnaire measuring current mental well-being on a scale from 0-100 points where higher points indicates better mental well-being
Change in The WHO-5 Well-being index from baseline to 12-months post-stroke	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
Change in Montreal Cognitive Assessment from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	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
Change in Montreal Cognitive Assessment from baseline to 12-months post-stroke	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
Change in Fatigue Severity Scale from baseline to 12-months post-stroke	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
Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke	From baseline to 12-months post-stroke	Four questions on General fatigue is calculated on a score from 4-20, with higher scores representing increased fatigue
Change in The Multidimensional Fatigue Inventory from baseline to 12-months post-stroke	From baseline to 12-months post-stroke	Four questions on General fatigue is calculated on a score from 4-20, with higher scores representing increased fatigue
Change in the Stages of exercise behavior change from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	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
Change in the Stages of exercise behavior change from baseline to 12-months post-stroke	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
Change in Physical Activity Scale	from baseline to 3 months (post-intervention)	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.
Change in Physical Activity Scale from baseline to 12-months post-stroke	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.
Change in maximum cardiopulmonary exercise test from baseline to 3 months post-stroke	from baseline to 3 months (post-intervention)	A maximal exercise test on a stationary bicycle

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Copenhagen, Herlev, Denmark

Department of Neurology, Herlev-Gentofte Hospital; 🇩🇰 Herlev, Denmark