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Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses (Exercise)

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ClinicalTrials.gov Identifier: NCT00912561
Recruitment Status : Terminated (slow recruiting)
First Posted : June 3, 2009
Last Update Posted : February 22, 2012
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany

Study Description
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Brief Summary:
The purpose of this trial is to study the improvement of cerebral hemodynamics in high risk stroke patients with impaired Cerebrovascular Reserve (CVR) due to high grade stenosis of the internal carotid (ICA) or middle cerebral artery (MCA) by Intense Aerobic Exercise (IAEx).

Condition or disease Intervention/treatment Phase
Stenosis Behavioral: Intense aerobic exercise Not Applicable

Detailed Description:

The primary objective: Intense aerobic exercise (24/8 weeks) improves CVR > 20% measured by Transcranial Doppler (TCD) in patients with hemodynamic relevant intra- or extracranial stenoses by enhanced cerebral arterio- and angiogenesis.

Secondary objectives:

Intense aerobic exercise (24/8 weeks) leads to:

  • an increase of Endothelial progenitor cell counts (EPCs)
  • qualitative and quantitative changes of endothelial markers and cytokines representing the inflammatory activity of atherosclerosis and neovascularisation
  • an improvement in cognitive performance and quality of life (QoL)
  • changes of the mean vessel size and of cerebral perfusion
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Study Start Date : June 2009
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Sedentary
patients who train after an 8 week observational period
Active Comparator: patients who train immediately after enrollment
patients who train immediately after enrollment
 Behavioral: Intense aerobic exercise
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. change of cerebrovascular reserve capacity [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]

Secondary Outcome Measures :
  1. Endothelial Progenitor Cells, cyto- and chemokines [ Time Frame: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]
  2. Neuropsychological Testing/ Quality of life [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • high-grade stenosis of the intra- or extracranial ICA or the MCA with ipsilateral impairment of the CVR capacity measured by TCD

Exclusion Criteria:

  • continuous physical activity ≥ 60 min/week within the last 3 months
  • cerebral bleeding or ischaemic stroke < 3 months
  • contraindications for spiro-ergometry, IAEx, or MRI
Contacts and Locations
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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): NCT00912561


Locations
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Germany
Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
Berlin, Germany, 12200
Sponsors and Collaborators
Gerhard Jan Jungehuelsing
German Federal Ministry of Education and Research
More Information
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Responsible Party: Gerhard Jan Jungehuelsing, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00912561    
Other Study ID Numbers: CCBF-Exercise
EA4/106/08
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany:
chronic brain ischaemia
stroke prevention
exercise
physical training
Chronic, extra- or intracranial stenoses of brain supplying arteries
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical