Effects of Intense Aerobic Exercise on the Cerebrovascular Reserve Capacity in Patients With Hemodynamically Relevant Intra- and Extracranial Stenoses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change of cerebrovascular reserve capacity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sedentary
patients who train after an 8 week observational period
patients who train immediately after enrollment
patients who train immediately after enrollment
Intervention: Intense aerobic exercise (Behavioral)
Outcomes
Primary Outcomes
change of cerebrovascular reserve capacity
Time Frame: immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up
Secondary Outcomes
- 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)
Investigators
Gerhard Jan Jungehuelsing
MD
Charite University, Berlin, Germany