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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
71
high intensity training 5 days a week for 12 weeks
Usual care medication for stroke prophylaxis
Advise on diet, alcohol, smoking and exercise
Herlev Hospital, Dept Neurology
Herlev, Denmark
Difference in the 'Graded Cycling Test with Talk Test'
Sub-maximal exercise test on a stationary bicycle
Time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Endothelial response
measurement of endothelial response by Endopat2000
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Major Depression Inventory (MDI)
A self-report mood questionnaire
Time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
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Multidimensional Fatigue Inventory (MFI-20)
A 20-item self-report instrument designed to measure fatigue.
Time frame: 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.
Time frame: At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Blood samples
Blood samples to determine cardiovascular risk factors
Time frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Magnetic resonance Imaging (MRI)
Detection of new infarcts or white matter lesions
Time frame: 12 months after baseline testing