The Effect of Aerobic Exercise in Patients With Lacunar Stroke

Not Applicable

Active, not recruiting

• Conditions: Stroke, Lacunar
• Interventions: Drug: prophylactic stroke medication; Other: High-intensity training; Behavioral: Recommendations for lifestyle changes

• Registration Number: NCT02731235
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-22
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-05
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-04
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	prophylactic stroke medication	Prophylactic stroke medication and recommendations for lifestyle changes
Exercise	High-intensity training	Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
Exercise	prophylactic stroke medication	Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
Exercise	Recommendations for lifestyle changes	Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
Control	Recommendations for lifestyle changes	Prophylactic stroke medication and recommendations for lifestyle changes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Magnetic resonance Imaging (MRI)	12 months after baseline testing	Detection of new infarcts or white matter lesions
Endothelial response	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing	measurement of endothelial response by Endopat2000
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
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.
Major Depression Inventory (MDI)	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing	A self-report mood questionnaire
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
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.
Blood samples	at baseline, 3 (primary analysis), 6 and 12 months after baseline testing	Blood samples to determine cardiovascular risk factors
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)

Trial Locations

Locations (1)

Herlev Hospital, Dept Neurology; 🇩🇰 Herlev, Denmark