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| ID | Type | Description | Link |
|---|---|---|---|
| BMBF-G.2.15 | Other Grant/Funding Number | G.2.15 |
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The purpose of this observational study is to examine the effects of 4-weeks of physical fitness training in patients with subacute ischemic stroke on cerebral imaging and blood-derived biomarkers.
This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled trial "Physical Fitness Training in Subacute Stroke" (PHYS-STROKE). 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 blood tests before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion and vessel size imaging. Blood tests will determine several parameters such as immunity, inflammation (including neopterin, MMP-9), metabolism (including ApoCIII, oxidized LDL, HOMA-index, uric acid, CK-MB, cystatin c, and leptin), cytokines (osteopontin, adiponectin), and endothelial function (SDF1-alpha, ADMA, sICAM, sVCAM, E-selectin, P-selectin). Additionally, we will assess the association between functional outcomes (co-primary outcome measures of PHYS-STROKE) and biomarkers including imaging results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Fitness | Patients from this group underwent 4 weeks of aerobic fitness training additional to normal supportive care, 5 times a week, for 50 minutes | ||
| Relaxation | Patients of this group received 4-weeks of relaxation sessions additional to normal supportive care, 5 times a week, for 50 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cerebral perfusion | Magnetic resonance imaging (MRI)-based cerebral perfusion are assessed before and after the 4-weeks of physical fitness training. Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients. | baseline and 4-weeks |
| Blood-derived biomarkers | Changes in blood biomarkers are assessed before and after the 4-weeks intervention of physical fitness training. Primary and secondary endpoints are specified after completion of the interim analysis after inclusion of the first 24 patients (first stage). In a second stage the study is conducted with specified primary and secondary endpoints with recruitment of up to 76 remaining patients. | baseline and 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| next cerebrovascular event | Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke | 6 months |
| functional outcome |
| Measure | Description | Time Frame |
|---|---|---|
| functional outcome | Analyzing how changes in imaging measures and blood-derived biomarkers are related to each other and to differences in functional outcome, in particular gait speed, Barthel index (co-primary endpoints of PHYS-STROKE) and modified Rankin Scale | 3 months |
| endothelial function assessment |
Inclusion Criteria:
Exclusion Criteria:
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Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Ebinger, MD | Center for Stroke Research Berlin | Principal Investigator |
| Alexander H Nave, MD | Center for Stroke Research Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42340058 | Derived | Kufner A, Tang Y, Temuulen U, Abbas G, Rackoll T, Grittner U, Kroneberg D, Weigl B, Kuhn AA, Reich M, Nave AH, Endres M. Who Falls After a Stroke? Evidence From a Prospective Stroke Cohort. Eur J Neurol. 2026 Jun;33(6):e70678. doi: 10.1111/ene.70678. | |
| 40620229 | Derived | Rios AS, Temuulen U, Khalil AA, Villringer K, Ali HF, Akdeniz A, Grittner U, Becher M, Rackoll T, Nave AH, Sperber PS, Liman TG, Otte C, Endres M, Kufner A. Lesion-Network Mapping of Poststroke Depressive Symptoms: Evidence From Two Prospective Ischemic Stroke Cohorts. Stroke. 2025 Sep;56(9):2527-2539. doi: 10.1161/STROKEAHA.125.051858. Epub 2025 Jul 7. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2017 | Jun 4, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Patients will receive blood draws (whole blood) for blood biomarker analyses.
functional outcome assessed via functional scores such as Barthel Index and walking speed (co-primary endpoints of PHYS-STROKE) as well as the modified Rankin Scale (mRS)
| directly after the end of intervention and 3 months post stroke |
the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device. First measurement was conducted in January 11th 2014. Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups. |
| measurement before and after the 4 weeks intervention |
| Clinical biomarkers including vital Parameters | systolic and diastolic blood pressure, resting heart rate, body-mass-index, and waist-to-hip-ratio over time compared between study groups | measurements at baseline and all follow-up time points (measurement before and after the 4 weeks intervention, at 3 months and at 6 months after stroke) |
| 34819906 | Derived | Jodicke RA, Huo S, Krankel N, Piper SK, Ebinger M, Landmesser U, Floel A, Endres M, Nave AH. The Dynamic of Extracellular Vesicles in Patients With Subacute Stroke: Results of the "Biomarkers and Perfusion-Training-Induced Changes After Stroke" (BAPTISe) Study. Front Neurol. 2021 Nov 8;12:731013. doi: 10.3389/fneur.2021.731013. eCollection 2021. |
| 34744972 | Derived | Muller S, Kufner A, Dell'Orco A, Rackoll T, Mekle R, Piper SK, Fiebach JB, Villringer K, Floel A, Endres M, Ebinger M, Nave AH. Evolution of Blood-Brain Barrier Permeability in Subacute Ischemic Stroke and Associations With Serum Biomarkers and Functional Outcome. Front Neurol. 2021 Oct 20;12:730923. doi: 10.3389/fneur.2021.730923. eCollection 2021. |
| 24330706 | Derived | Nave AH, Krober JM, Brunecker P, Fiebach JB, List J, Grittner U, Endres M, Meisel A, Floel A, Ebinger M. Biomarkers and perfusion--training-induced changes after stroke (BAPTISe): protocol of an observational study accompanying a randomized controlled trial. BMC Neurol. 2013 Dec 11;13:197. doi: 10.1186/1471-2377-13-197. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |