Biomarkers and Perfusion - Training-Induced Changes After Stroke

NCT01954797 | Completed DMC

• 2 other identifiers: BAPTISeBMBF-G.2.15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Physical fitness; relaxation; stroke; cerebral ischemia; cerebral perfusion; biomarkers; MRI

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• next cerebrovascular event

  6 months

• functional outcome

  directly after the end of intervention and 3 months post stroke

Other Outcomes (3)

• functional outcome

  3 months

• endothelial function assessment

  measurement before and after the 4 weeks intervention

• Clinical biomarkers including vital Parameters

  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)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Related Publications (4)

• 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.

  PMID: 40620229 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.

  PMID: 34819906 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.

  PMID: 34744972 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.

  PMID: 24330706 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients will receive blood draws (whole blood) for blood biomarker analyses.

MeSH Terms

Conditions

Stroke; Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin Ebinger, MD

  Center for Stroke Research Berlin

  PRINCIPAL INVESTIGATOR

• Alexander H Nave, MD

  Center for Stroke Research Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

DE (1)