Stroke, Lacunar
Conditions
Keywords
Stroke, stroke, acute, Cerebral small vessel disease
Brief summary
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
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.
Interventions
high intensity training 5 days a week for 12 weeks
DRUGprophylactic stroke medication
Usual care medication for stroke prophylaxis
BEHAVIORALRecommendations for lifestyle changes
Advise on diet, alcohol, smoking and exercise
Sponsors
University of Copenhagen
Association of Danish Physiotherapists
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the 'Graded Cycling Test with Talk Test' | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | Sub-maximal exercise test on a stationary bicycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial response | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | measurement of endothelial response by Endopat2000 |
| Physical Activity Scale (PAS) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | A questionnaire that measures the level of self-reported physical activity |
| Short time activity measurements | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | 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) |
| The WHO-five Well-being Index (WHO-5) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | A questionnaire that measures current mental well-being |
| Montreal Cognitive Assessment (MOCA) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | A cognitive screening test for detection of mild cognitive impairments |
| Multidimensional Fatigue Inventory (MFI-20) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | A 20-item self-report instrument designed to measure fatigue. |
| Ull-Meter | At baseline, 3 (primary analysis), 6 and 12 months after baseline testing | An instrument which measures the individual stress reaction - it presents an objective number for the body and mind's state of stress. |
| Blood samples | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | Blood samples to determine cardiovascular risk factors |
| Magnetic resonance Imaging (MRI) | 12 months after baseline testing | Detection of new infarcts or white matter lesions |
| Major Depression Inventory (MDI) | at baseline, 3 (primary analysis), 6 and 12 months after baseline testing | A self-report mood questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardio-vascular event or death | 5 years | Follow-up 5 years from inclusion on cardiovascular events or death |
Countries
Denmark
Outcome results
None listed