ExStroke Pilot Trial: Physical Exercise After Acute Ischaemic Stroke

NCT00132483 | Completed Phase 3 DMC

• 1 other identifier: ExStroke Pilot Trial
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Physical activity; cerebral infarct

Outcome Measures

Primary Outcomes (1)

• Difference in physical activity scale for the elderly

  24 months

Secondary Outcomes (1)

• Occurrence of stroke, MI or death

  24 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Behavioral: Instruction in physical training program

Control

NO INTERVENTION

Interventions

Instruction in physical training program BEHAVIORAL

Instruction in physical training program.

Intervention arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Informed consent after verbal and written information.
• The patient must be able to walk either unaided or with a cane or a walker.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• Boysen G, Krarup LH, Zeng X, Oskedra A, Korv J, Andersen G, Gluud C, Pedersen A, Lindahl M, Hansen L, Winkel P, Truelsen T; ExStroke Pilot Trial Group. ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial. BMJ. 2009 Jul 22;339:b2810. doi: 10.1136/bmj.b2810.

  PMID: 19900934 DERIVED

• Krarup LH, Gluud C, Truelsen T, Pedersen A, Lindahl M, Hansen L, Michelsen S, Andersen G, Zeng X, Korv J, Oskedra A, Boysen G; ExStroke Pilot Trial Group. The ExStroke Pilot Trial: rationale, design, and baseline data of a randomized multicenter trial comparing physical training versus usual care after an ischemic stroke. Contemp Clin Trials. 2008 May;29(3):410-7. doi: 10.1016/j.cct.2007.09.008. Epub 2007 Oct 9.

  PMID: 18029233 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity; Cerebral Infarction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Gudrun Boysen, MD

  Dept. of Neurology, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: September 1, 2003
• Study Completion: October 1, 2007
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

DK (1)