An interventional study of Cardiorespiratory exercise combined with patient education and individual follow-up sessions in Minor Stroke, Non-disabling Stroke and Transient Ischemic Attack, sponsored by Herlev Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Herlev Hospital · Not applicable, Interventional, and Prevention
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.
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.
329 studies on the registry are indexed under Ischemic Attack, Transient; 71 are open to participants now.
This study's planned enrollment of 100 is below the median of 217 across 178 interventional studies indexed under Ischemic Attack, Transient.
Browse Ischemic Attack, Transient studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The usual care group is encouraged to perform home-based aerobic exercise on their own
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
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
Time frame: from baseline to 3 months (post-intervention)
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 12-months post-stroke
Change in Anxiety and depression from baseline to 3 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.
Time frame: from baseline to 3 months (post-intervention)
Change in Anxiety and depression 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.
Time frame: 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
Time frame: 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
Time frame: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory from baseline to 3-months post-stroke
Four questions on General fatigue is calculated on a score from 4-20, with higher scores representing increased fatigue
Time frame: From baseline to 12-months post-stroke
Change in The Multidimensional Fatigue Inventory 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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".
Time frame: 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".
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to 12-months post-stroke
Number of patients with cardiovascular event from baseline to 5 years post-stroke
Follow-up 5 years from inclusion on cardiovascular events
Time frame: 5 years post-stroke
Number of patients who have died from baseline to 5 years post-stroke
Follow-up 5 years from inclusion on death
Time frame: 5 years post stroke
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Dec 2028, 78 months after the start.
Of 64 non-industry interventional studies with no phase under Ischemic Attack, Transient, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 72. This study's planned 78 months is above that.
Counting every sponsor, half of 71 studies reached it within 46 months; a quarter within 23 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
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