Open Access Open Badges Study protocol

Biomarkers and perfusion – training-induced changes after stroke (BAPTISe): protocol of an observational study accompanying a randomized controlled trial

Alexander H Nave12*, Jan M Kröber12, Peter Brunecker1, Jochen B Fiebach12, Jonathan List2, Ulrike Grittner15, Matthias Endres1234, Andreas Meisel123, Agnes Flöel123 and Martin Ebinger12

Author Affiliations

1 Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany

2 Department of Neurology, Charité - Universätsmedizin Berlin, Berlin, Germany

3 NeuroCure Clinical Research Center, Charité - Universätsmedizin Berlin, Berlin, Germany

4 Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), Standort Berlin, Germany

5 Department for Biostatistics and Clinical Epidemiology, Charité - Universätsmedizin Berlin, Berlin, Germany

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BMC Neurology 2013, 13:197  doi:10.1186/1471-2377-13-197

Published: 11 December 2013



Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke. Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation, the underlying mechanisms leading to improvement are poorly understood. Training-induced increase of cerebral perfusion is a possible mediating mechanism. Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke.


This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled PHYS-STROKE trial. In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4 weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4 weeks of relaxation sessions (5 times a week, for 50 minutes). A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and an additional blood draw before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion, vessel size imaging, and microvessel density (the Q factor) to estimate the degree of neovascularization in the brain. Blood tests will determine several parameters of immunity, inflammation, endothelial function, and lipometabolism. Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups. Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3 months assessed by functional scores, in particular walking speed and Barthel index (co-primary endpoints of PHYS-STROKE). Additionally, we will assess the association between functional outcomes and biomarkers including imaging results. For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions.


This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion, pertinent blood biomarker levels, and functional outcome. The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke.

Trial registration


Physical training; Exercise; Subacute stroke; Ischemic stroke; Cerebral perfusion; Biomarkers; Vessel size imaging; Neovascularization; MRI; Rehabilitation