Biomarkers and Perfusion - Training-Induced Changes After Stroke

Completed

• Conditions: Stroke

• Registration Number: NCT01954797
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2013-09-27
• Study Start: 2013-10
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-07
• Primary Completion: 2017-07
• Study Completion: 2017-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood-derived biomarkers	baseline and 4-weeks	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.
Cerebral perfusion	baseline and 4-weeks	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.

Secondary Outcome Measures

Name	Time	Method
functional outcome	directly after the end of intervention and 3 months post stroke	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)
next cerebrovascular event	6 months	Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany