StrokeBAPTISeNCT01954797
Biomarkers and Perfusion - Training-Induced Changes After Stroke
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Physical fitness, relaxation, stroke, cerebral ischemia, cerebral perfusion, biomarkers, MRI
- Medical subject headings
- Stroke, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline and 4-weeks
Secondary outcomes (2)
next cerebrovascular event
Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke
Measured: 6 months
functional outcome
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)
Measured: directly after the end of intervention and 3 months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander H Nave, Charite University, Berlin, Germany
- Investigators
- Martin Ebinger, MD, Principal investigator, Center for Stroke Research BerlinAlexander H Nave, MD, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954797
- Sponsor's protocol ID
- BAPTISe
- Other IDs
- BMBF-G.2.15
- Acronym
- BAPTISe
- Status last verified
- Jun 2019
- First submitted
- 27 Sep 2013
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Kufner A, Tang Y, Temuulen U, Abbas G, Rackoll T, Grittner U, Kroneberg D, Weigl B, Kuhn AA, Reich M, Nave AH, Endres M. Who Falls After a Stroke? Evidence From a Prospective Stroke Cohort. Eur J Neurol. 2026 Jun;33(6):e70678. doi: 10.1111/ene.70678.
PubMed 42340058Rios 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.
PubMed 40620229Jodicke 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.
PubMed 34819906Muller 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.
PubMed 34744972Nave 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.
PubMed 24330706
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe): Protocol of an Observational Study Accompanying a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01954797
- Acronym / sponsor ID
- BAPTISe / BAPTISe
- Conditions
- Stroke
- Keywords
- Physical fitness, relaxation, stroke, cerebral ischemia, cerebral perfusion, biomarkers, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cerebral perfusion
Time frame: 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.
Blood-derived biomarkers
Time frame: 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.
2 secondary outcomes
next cerebrovascular event
Time frame: 6 months
functional outcome
Time frame: directly after the end of intervention and 3 months post stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Derived from this study: PubMed 42340058Kufner A, Tang Y, Temuulen U, Abbas G, Rackoll T, Grittner U, Kroneberg D, Weigl B, Kuhn AA, Reich M, Nave AH, Endres M. Who Falls After a Stroke? Evidence From a Prospective Stroke Cohort. Eur J Neurol. 2026 Jun;33(6):e70678. doi: 10.1111/ene.70678.
- Derived from this study: PubMed 40620229Rios 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.
- Derived from this study: PubMed 34819906Jodicke 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.
- Derived from this study: PubMed 34744972Muller 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.
- Derived from this study: PubMed 24330706Nave 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Ebinger, MD principal investigator
Center for Stroke Research Berlin
Alexander H Nave, MD principal investigator
Center for Stroke Research Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral perfusion (time frame: baseline and 4-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954797, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.