Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe)

Charité University Medicine Berlin

Status: Completed

Conditions: Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT01954797

BMBF-G.2.15 (Other Grant/Funding Number)

BAPTISe

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Physical Fitness

Description:

Patients from this group underwent 4 weeks of aerobic fitness training additional to normal supportive care, 5 times a week, for 50 minutes

Relaxation

Description:

Patients of this group received 4-weeks of relaxation sessions additional to normal supportive care, 5 times a week, for 50 minutes.