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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

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
change of cerebrovascular reserve capacity [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • Endothelial Progenitor Cells, cyto- and chemokines [ Time Frame: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]
  • Neuropsychological Testing/ Quality of life [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Official Title  ICMJE Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stenosis
Intervention  ICMJE Behavioral: Intense aerobic exercise
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Intense aerobic exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: June 2, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00912561
Other Study ID Numbers  ICMJE CCBF-Exercise
EA4/106/08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
Study Sponsor  ICMJE Gerhard Jan Jungehuelsing
Collaborators  ICMJE German Federal Ministry of Education and Research
Investigators  ICMJE Not Provided
PRS Account Charite University, Berlin, Germany
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP