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Clinical Trials/NCT01070459
NCT01070459
Unknown
Phase 3

The Effect of an Aerobic Training Programme on the Aerobic Capacity, Functional Behavior and the Cardiovascular Risk Factors in Stroke Patients

University College of Antwerp1 site in 1 country50 target enrollmentFebruary 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
University College of Antwerp
Enrollment
50
Locations
1
Primary Endpoint
VO2-peak, strength, walking, activities of daily living
Last Updated
16 years ago

Overview

Brief Summary

This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke patients.

Detailed Description

People with neurologic impairments after stroke often show decreased aerobic exercise capacity. The etiologies of which are assigned to physiologic changes in paretic muscle, gait deficits and disability-related deconditioning. This declares that stroke patients live an inactive lifestyle and therefore stay cardiovascular risk patients. The usefulness of aerobic training on aerobic capacity is recently been proved in clinical stroke research. However, no study can shown the long-term effect of aerobic exercises. Also the effect of aerobic exercises on daily functioning, fatigue and depression in stroke needs to be established.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
December 2011
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University College of Antwerp

Eligibility Criteria

Inclusion Criteria

  • First CVA according to the WHO definition (A primary, first ever stroke ash revealed by rapidly developing clinical signs or focal or global disturbance or cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than or vascular origin.) This includes ischemic infarct or an intracerebral haemorrhage
  • The offense can be maximum 3 up to 6 weeks after onset
  • Patient must be able to follow simple verbal instructions
  • To cycle during 1 minute at 20 Watt, 50RPM,
  • Cardiac stable

Exclusion Criteria

  • Have another neurological impairments with permanent damage such as former cranial trauma, multiple sclerosis, epileptic status... which already present were for current CVA
  • Having on CVA resembling symptoms as a result of subdural haemorrhage, a tumour, encephalitis or a trauma
  • Barthel index \< 50 before the stroke onset
  • Age \> 80 year
  • No authorisation form of the patient or of the family
  • Absolute contra-indications for effort test (ACC/AHA guidelines)

Outcomes

Primary Outcomes

VO2-peak, strength, walking, activities of daily living

Time Frame: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

Secondary Outcomes

  • post-stroke fatigue, depression, lifestyle, cardiovascular risk factors(baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)

Study Sites (1)

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