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

Stenosis Clinical Trial

— Exercise  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00912561
• Other study ID #: CCBF-Exercise
• Secondary ID: EA4/106/08
• Status: Terminated
• Phase: N/A
• First received: June 2, 2009
• Last updated: February 20, 2012
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Stenosis

Intervention

Behavioral:
• Intense aerobic exercise
3 Units (of at least 30 minutes) of intense aerobic exercise per week for 8 weeks

Locations

Country	Name	City	State
Germany	Centre for Stroke Research Berlin, Neurology, Charité Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Gerhard Jan Jungehuelsing	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of cerebrovascular reserve capacity		immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up	No
Secondary	Endothelial Progenitor Cells, cyto- and chemokines		after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up	No
Secondary	Neuropsychological Testing/ Quality of life		immediately after intervention of 8 weeks, 3 months, 6 months, 12 months Follow up	No