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

Not Applicable

Terminated

• Conditions: Stenosis
• Interventions: Behavioral: Intense aerobic exercise

• Registration Number: NCT00912561
• Lead Sponsor: Gerhard Jan Jungehuelsing

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Primary Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
patients who train immediately after enrollment	Intense aerobic exercise	patients who train immediately after enrollment

Primary Outcome Measures

Name	Time	Method
change of cerebrovascular reserve capacity	immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany