Clinical trial NCT01954797: Biomarkers and Perfusion - Training-Induced Changes After Stroke
Official title: Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe): Protocol of an Observational Study Accompanying a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Physical fitness
relaxation
stroke
cerebral ischemia
cerebral perfusion
biomarkers
MRI
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral perfusion
timeFrame: baseline and 4-weeks
measure: Blood-derived biomarkers
timeFrame: baseline and 4-weeks
Secondary outcomes:
measure: next cerebrovascular event
timeFrame: 6 months
measure: functional outcome
timeFrame: directly after the end of intervention and 3 months post stroke
Other outcomes:
measure: functional outcome
timeFrame: 3 months
measure: endothelial function assessment
timeFrame: measurement before and after the 4 weeks intervention
measure: Clinical biomarkers including vital Parameters
timeFrame: 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)
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Center for Stroke Research Berlin
name: Martin Ebinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Stroke Research Berlin
name: Alexander H Nave, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.