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

Gerhard Jan Jungehuelsing

Status: Terminated

Conditions: Stenosis

Treatments: Behavioral: Intense aerobic exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00912561

EA4/106/08

CCBF-Exercise

Details and patient eligibility

About

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).

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Sedentary

No Intervention group

Description:

patients who train after an 8 week observational period

patients who train immediately after enrollment

Active Comparator group

Description:

patients who train immediately after enrollment

Treatment:

Behavioral: Intense aerobic exercise