Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: Summary

This study will look at physical exercise after acute ischaemic stroke. It is called the ExStroke Pilot Trial.

Physical activity is associated with a lower risk of first-time stroke. It remains unknown if physical activity also is associated with a lower risk of recurrent stroke. Patients with ischaemic stroke have a 30% to 40% risk of a recurrent stroke during a 5 year follow-up. The risk of acute myocardial infarction (MI) and death from vascular disease is approximately 15% each. The impact of lifestyle factors on risk for these events is insufficiently covered in the international scientific literature.

Purpose:

The purpose of the trial is to examine whether the level of physical activity increases in patients who have had an ischemic stroke, when they are informed about physical activity and instructed in a physical training program. The occurrence of new cerebro- and cardiovascular events in the patients will be registered. The patients are randomised to receive oral and written information by a physician and a physiotherapist about physical exercise; or to a control group with no instruction regarding physical exercise. Both groups will receive the best available therapy with regard to secondary stroke prevention and will be informed about lifestyle factors.

Irrespective of which group the patients are randomised to, all patients will receive the best possible established treatment with regard to prevention of thromboses; blood pressure control; lipid lowering agents, if necessary; and information about diet, tobacco smoking, and vitamin supplements.

Study Design:

The patients will be randomised centrally within 90 days after stroke onset, and they will be re-examined at 3, 6, 9, 12, 18, and 24 months. Inclusion criteria are patients with ischaemic stroke, aged 40 years or older. In the pilot trial a number of 300 included patients is wanted.


Options:
A: Inclusion Criteria:

* Subjects aged 40 years or older.
* Patients with a clinical diagnosis of stroke; symptoms lasting 24 hours or more.
* Computed tomography (CT)-scan of the brain must either show a new infarct or be normal. Patients only with infarcts without clinical symptoms cannot be included.
* Inclusion shall take place before day 90 after stroke onset.
* Informed consent after verbal and written information.
* The patient must be able to walk either unaided or with a cane or a walker.

Exclusion Criteria:

* Patients who are unable to understand the information, or who cannot cooperate, are excluded.
* Patients confined to a wheelchair or bed.
* CT-scanning showing intracranial haemorrhage or focal pathology other than infarction, cerebral atrophy, or leucoaraiosis.
* Modified Rankin score of 4 or 5 before the actual stroke.
* Serious medical disease such as AIDS, metastatic cancer, or abnormalities that the investigator feels may compromise the patient's successful participation in the trial.
* Earlier randomisation in this trial.
B: 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
C: Inclusion Criteria:

* Diagnosis of stroke according to WHO's definition of stroke
* Living in the city of Trondheim or the municipalities of Asker or Bærum
* Included 2.5 - 4 months after stroke
* Modified Rankin Scale 0 - 4
* Living at home
* Mini Mental State Examination \> 20 or \> 16 if aphasia
* Provide informed consent

Exclusion Criteria:

* Are already included in the study
* Are included in other experimental studies
* Unstable coronary function
* Uncompensated heartfailure
* Other diseases that make it difficult to complete the intervention
D: Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke
* age ≥18;
* Functional Ambulation Classification (FAC) ≥3
* Barthel Index ≥45

Exclusion Criteria:

* Cognitive impairment (Mini Mental State Examination ≤24)
* Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
* Alcohol or other toxic substances abuse
* Decompensated psychiatric disorders that prevented from following a group session

Answer: A