ExStroke Pilot Trial: Physical Exercise After Acute Ischaemic Stroke
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|ClinicalTrials.gov Identifier: NCT00132483|
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : October 22, 2007
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Instruction in physical training program||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||October 2007|
|Experimental: Intervention arm||
Behavioral: Instruction in physical training program
Instruction in physical training program.
|No Intervention: Control|
- Difference in physical activity scale for the elderly [ Time Frame: 24 months ]
- Occurrence of stroke, MI or death [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132483
|Copenhagen, Denmark, 2400|
|Principal Investigator:||Gudrun Boysen, MD||Dept. of Neurology, Bispebjerg Hospital|