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ExStroke Pilot Trial: Physical Exercise After Acute Ischaemic Stroke

This study has been completed.

Sponsored by: Bispebjerg Hospital
Information provided by: Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00132483
  Purpose

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.


Condition Intervention Phase
Stroke
Behavioral: Instruction in physical training program
Phase III

MedlinePlus related topics:   Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Difference in physical activity scale for the elderly [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Occurrence of stroke, MI or death [ Time Frame: 24 months ]

Enrollment:   314
Study Start Date:   September 2003
Study Completion Date:   October 2007

Arms Assigned Interventions
Intervention arm: Experimental Behavioral: Instruction in physical training program
Instruction in physical training program.
Control: No Intervention

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132483

Locations
Denmark
Bispebjerg Hospital    
      Copenhagen, Denmark, 2400

Sponsors and Collaborators
Bispebjerg Hospital

Investigators
Principal Investigator:     Gudrun Boysen, MD     Dept. of Neurology, Bispebjerg Hospital    
  More Information


Publications indexed to this study:

Study ID Numbers:   ExStroke Pilot Trial
First Received:   August 19, 2005
Last Updated:   October 19, 2007
ClinicalTrials.gov Identifier:   NCT00132483
Health Authority:   Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:
Physical activity  
cerebral infarct  

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 05, 2008




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