Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)
5 de junio de 2019 actualizado por: Alexander H Nave, Charite University, Berlin, Germany
Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe): Protocol of an Observational Study Accompanying a Randomized Controlled Trial
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania, 10117
- Charite - Universitatsmedizin Berlin
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.
Descripción
Inclusion Criteria:
- Age: > 18 years
- Diagnosis of subacute ischemic stroke (within 5-45 days after stroke onset)as determined by initial MRI/CT scan of the brain
- Cortical, sub-cortical, or brainstem affection
- Barthel Index (BI) <65 at inclusion
- Able to sit for at least 30 seconds (unsupported or supported, i.e., holding onto supports such as the edge of the bed)
- Ability to perform aerobic exercise, determined by by responsible physician
- Provision of written informed consent
Exclusion Criteria:
- Lacking ability to comply with study requirements
- Stroke due to intracranial haemorrhage
- Previous subarachnoid hemorrhage or other hemorrhagic stroke
- Progressive stroke
- Not able to receive magnetic resonance imaging scans, including perfusion imaging
- Unable to perform the required exercises due to medical, musculoskeletal, or neurological problems
- Required help of at least 1 person to walk before stroke due to neurological (e. g., advanced Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis) or non-neurological co-morbidities (e. g. heart failure, orthopaedic problems)
- Life expectancy < 1 year as determined by responsible physician
- Drug or alcohol addiction within the last six months
- Significant current psychiatric illness defined as medication-refractory of bipolar affective disorder, psychosis, schizophrenia or suicidality
- Current participation in another interventional trial
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cerebral perfusion
Periodo de tiempo: baseline and 4-weeks
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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
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Blood-derived biomarkers
Periodo de tiempo: baseline and 4-weeks
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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next cerebrovascular event
Periodo de tiempo: 6 months
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Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke
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6 months
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functional outcome
Periodo de tiempo: directly after the end of intervention and 3 months post stroke
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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)
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directly after the end of intervention and 3 months post stroke
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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functional outcome
Periodo de tiempo: 3 months
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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
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3 months
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endothelial function assessment
Periodo de tiempo: measurement before and after the 4 weeks intervention
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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.
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measurement before and after the 4 weeks intervention
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Clinical biomarkers including vital Parameters
Periodo de tiempo: 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)
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systolic and diastolic blood pressure, resting heart rate, body-mass-index, and waist-to-hip-ratio over time compared between study groups
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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)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Martin Ebinger, MD, Center for Stroke Research Berlin
- Investigador principal: Alexander H Nave, MD, Center for Stroke Research Berlin
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2013
Finalización primaria (Actual)
1 de julio de 2017
Finalización del estudio (Actual)
1 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
27 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
4 de octubre de 2013
Publicado por primera vez (Estimar)
7 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
5 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BAPTISe
- BMBF-G.2.15 (Otro número de subvención/financiamiento: G.2.15)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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