The Effect of Aerobic Exercise in Patients With Lacunar Stroke (HITPALS)

Herlev Hospital

Status: Active, not recruiting

Conditions: Stroke, Lacunar

Treatments: Other: High-intensity training; Behavioral: Recommendations for lifestyle changes; Drug: prophylactic stroke medication

Study type: Interventional

Funder types: Other

Identifiers

NCT02731235

H-15012371

Details and patient eligibility

About

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 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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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71 participants in 2 patient groups

Control

Other group

Description:

Prophylactic stroke medication and recommendations for lifestyle changes

Treatment:

Behavioral: Recommendations for lifestyle changes

Drug: prophylactic stroke medication

Exercise

Active Comparator group

Description:

Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks

Treatment:

Other: High-intensity training

Behavioral: Recommendations for lifestyle changes

Drug: prophylactic stroke medication