Back to resultsEffects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses (Exercise)
Primary Purpose
Stenosis
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intense aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stenosis focused on measuring chronic brain ischaemia, stroke prevention, exercise, physical training, Chronic, extra- or intracranial stenoses of brain supplying arteries
Eligibility 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
Sites / Locations
- Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Sedentary
patients who train immediately after enrollment
Arm Description
patients who train after an 8 week observational period
patients who train immediately after enrollment
Outcomes
Primary Outcome Measures
change of cerebrovascular reserve capacity
Secondary Outcome Measures
Endothelial Progenitor Cells, cyto- and chemokines
Neuropsychological Testing/ Quality of life
Full Information
NCT ID
NCT00912561
First Posted
June 2, 2009
Last Updated
February 20, 2012
Sponsor
Gerhard Jan Jungehuelsing
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00912561
Brief Title
Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Acronym
Exercise
Official Title
Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
slow recruiting
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gerhard Jan Jungehuelsing
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis
Keywords
chronic brain ischaemia, stroke prevention, exercise, physical training, Chronic, extra- or intracranial stenoses of brain supplying arteries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sedentary
Arm Type
No Intervention
Arm Description
patients who train after an 8 week observational period
Arm Title
patients who train immediately after enrollment
Arm Type
Active Comparator
Arm Description
patients who train immediately after enrollment
Intervention Type
Behavioral
Intervention Name(s)
Intense aerobic exercise
Intervention Description
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks
Primary Outcome Measure Information:
Title
change of cerebrovascular reserve capacity
Time Frame
immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Secondary Outcome Measure Information:
Title
Endothelial Progenitor Cells, cyto- and chemokines
Time Frame
after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Title
Neuropsychological Testing/ Quality of life
Time Frame
immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
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