The Effect of Aerobic Exercise in Patients With Lacunar Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stroke School -Including Physical Exercise, Patient Education and Individual Follow-up Sessions

NCT04945174

Minor Stroke Non-disabling Stroke Transient Ischemic Attack

RECRUITING NA

Physical Activity Immediately After Acute Cerebral Ischemia 3

NCT01712282

Acute Ischemic Stroke

UNKNOWN NA

Motivators and Barriers for Physical Activity in Patients With Minor Stroke

NCT04332458

Stroke, Ischemic

COMPLETED NA

Forced Aerobic Exercise for Stroke Rehabilitation

NCT02494518

Stroke

COMPLETED NA

Physical Activity Immediately After Acute Cerebral Ischemia

NCT01594190

Acute Ischemic Stroke Physical Activity Accelerometer

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Lacunar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Prophylactic stroke medication and recommendations for lifestyle changes

Group Type OTHER

prophylactic stroke medication

Intervention Type DRUG

Usual care medication for stroke prophylaxis

Recommendations for lifestyle changes

Intervention Type BEHAVIORAL

Advise on diet, alcohol, smoking and exercise

Exercise

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

Group Type ACTIVE_COMPARATOR

High-intensity training

Intervention Type OTHER

high intensity training 5 days a week for 12 weeks

prophylactic stroke medication

Intervention Type DRUG

Usual care medication for stroke prophylaxis

Recommendations for lifestyle changes

Intervention Type BEHAVIORAL

Advise on diet, alcohol, smoking and exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-intensity training

high intensity training 5 days a week for 12 weeks

Intervention Type OTHER

prophylactic stroke medication

Usual care medication for stroke prophylaxis

Intervention Type DRUG

Recommendations for lifestyle changes

Advise on diet, alcohol, smoking and exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No