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

This study has been terminated.
(slow recruiting)
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jan Jungehuelsing, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00912561
First received: June 2, 2009
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Stenosis
 Behavioral: Intense aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • change of cerebrovascular reserve capacity [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial Progenitor Cells, cyto- and chemokines [ Time Frame: after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ] [ Designated as safety issue: No ]
  • Neuropsychological Testing/ Quality of life [ Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912561

Locations
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

No publications provided

Responsible Party: Gerhard Jan Jungehuelsing, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00912561     History of Changes
Other Study ID Numbers: CCBF-Exercise, EA4/106/08
Study First Received: June 2, 2009
Last Updated: February 20, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by 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:
Constriction, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013