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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Association of Danish Physiotherapists | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Prophylactic stroke medication and recommendations for lifestyle changes |
|
| Exercise | Active Comparator | Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity training | Other | high intensity training 5 days a week for 12 weeks |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardio-vascular event or death | Follow-up 5 years from inclusion on cardiovascular events or death | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Christina Kruuse, MD, DMSc | Herlev Hospital, Dept Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital, Dept Neurology | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34184251 | Derived | Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2. | |
| 31316451 | Derived | Steen Krawcyk R, Vinther A, Petersen NC, Faber J, Iversen HK, Christensen T, Lambertsen KL, Rehman S, Klausen TW, Rostrup E, Kruuse C. Effect of Home-Based High-Intensity Interval Training in Patients With Lacunar Stroke: A Randomized Controlled Trial. Front Neurol. 2019 Jun 28;10:664. doi: 10.3389/fneur.2019.00664. eCollection 2019. |
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| ID | Term |
|---|---|
| D059409 | Stroke, Lacunar |
| D020521 | Stroke |
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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| prophylactic stroke medication |
| Drug |
Usual care medication for stroke prophylaxis |
|
| Recommendations for lifestyle changes | Behavioral | Advise on diet, alcohol, smoking and exercise |
|
| 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 |
| D000083244 | Thrombotic Stroke |
| D000083242 | Ischemic Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |