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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
Sponsor:
Information provided by:
Bispebjerg Hospital

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.


Condition or disease Intervention/treatment Phase
Stroke Behavioral: Instruction in physical training program Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2003
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention arm Behavioral: Instruction in physical training program
Instruction in physical training program.

No Intervention: Control



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
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Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Gudrun Boysen, MD Dept. of Neurology, Bispebjerg Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00132483     History of Changes
Other Study ID Numbers: ExStroke Pilot Trial
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: October 22, 2007
Last Verified: October 2007
Keywords provided by Bispebjerg Hospital:
Physical activity
cerebral infarct
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases