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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Stenosis

Intervention / Treatment
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* Behavioral: Intense aerobic exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sedentary<br>patients who train after an 8 week observational period | |
| Active Comparator: patients who train immediately after enrollment<br>patients who train immediately after enrollment | Behavioral: Intense aerobic exercise<br>* 3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of cerebrovascular reserve capacity |  | immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Progenitor Cells, cyto- and chemokines |  | after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up | 
| Neuropsychological Testing/ Quality of life |  | immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic brain ischaemia, stroke prevention, exercise, physical training, Chronic, extra- or intracranial stenoses of brain supplying arteries