The Effect of Aerobic Exercise in Patients With Lacunar Stroke

Overview

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.

Full Title of Study: “High-intensity Training in Patients With Lacunar Stroke (HITPALS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2023

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

  • Other: High-intensity training
    • high intensity training 5 days a week for 12 weeks
  • Drug: prophylactic stroke medication
    • Usual care medication for stroke prophylaxis
  • Behavioral: Recommendations for lifestyle changes
    • Advise on diet, alcohol, smoking and exercise

Arms, Groups and Cohorts

  • Other: Control
    • Prophylactic stroke medication and recommendations for lifestyle changes
  • Active Comparator: Exercise
    • Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Difference in the ‘Graded Cycling Test with Talk Test’
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • Sub-maximal exercise test on a stationary bicycle

Secondary Measures

  • Endothelial response
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • measurement of endothelial response by Endopat2000
  • Physical Activity Scale (PAS)
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • A questionnaire that measures current mental well-being
  • Montreal Cognitive Assessment (MOCA)
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • A cognitive screening test for detection of mild cognitive impairments
  • Major Depression Inventory (MDI)
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • A self-report mood questionnaire
  • Multidimensional Fatigue Inventory (MFI-20)
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • A 20-item self-report instrument designed to measure fatigue.
  • Ull-Meter
    • Time Frame: 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
    • Time Frame: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
    • Blood samples to determine cardiovascular risk factors
  • Magnetic resonance Imaging (MRI)
    • Time Frame: 12 months after baseline testing
    • Detection of new infarcts or white matter lesions

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Herlev Hospital
  • Collaborator
    • University of Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christina Kruuse, Associate professor, consultant neurologist – Herlev Hospital
  • Overall Official(s)
    • Christina Kruuse, MD, DMSc, Principal Investigator, Herlev Hospital, Dept Neurology

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