Clinical trial NCT02731235: The Effect of Aerobic Exercise in Patients With Lacunar Stroke
Official title: High-intensity Training in Patients With Lacunar Stroke (HITPALS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Lacunar
Keywords: Stroke
stroke, acute
Cerebral small vessel disease
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Association of Danish Physiotherapists
First posted: 2016-04-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the 'Graded Cycling Test with Talk Test'
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Secondary outcomes:
measure: Endothelial response
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Physical Activity Scale (PAS)
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Short time activity measurements
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: The WHO-five Well-being Index (WHO-5)
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Major Depression Inventory (MDI)
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Ull-Meter
timeFrame: At baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Blood samples
timeFrame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
measure: Magnetic resonance Imaging (MRI)
timeFrame: 12 months after baseline testing
Other outcomes:
measure: Cardio-vascular event or death
timeFrame: 5 years
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital, Dept Neurology
Study officials:
affiliation: Herlev Hospital, Dept Neurology
name: Christina Kruuse, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.