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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Martin Ebinger, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01954797
First received: September 27, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biomarkers and Perfusion - Training-Induced Changes After Stroke (BAPTISe): Protocol of an Observational Study Accompanying a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Cerebral perfusion [ Time Frame: baseline and 4-weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • next cerebrovascular event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Patients re-admitting hospital with suspected transient ischemic attack (TIA), stroke, or other cerebrovascular event within 6 months post stroke

  • functional outcome [ Time Frame: directly after the end of intervention and 3 months post stroke ] [ Designated as safety issue: No ]
    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)


Other Outcome Measures:
  • functional outcome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Analyzing how changes in imaging measures and blood-derived biomarkers are related to each other and to differences in functional outcome, in particular gait speed, Barthel index (co-primary endpoints of PHYS-STROKE) and modified Rankin Scale


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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, and endothelial function. Additionally, we will assess the association between functional outcomes (co-primary outcome measures of PHYS-STROKE) and biomarkers including imaging results.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954797

Contacts
Contact: Alexander H Nave +49(0)30450560 ext 137 alexander.nave@charite.de
Contact: Jan M Kröber +49(0)30450560 ext 137 jan.kroeber@charite.de

Locations
Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Martin Ebinger       martin.ebinger@charite.de   
Contact: Alexander H Nave       alexander.nave@charite.de   
Principal Investigator: Martin Ebinger         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Martin Ebinger Center for Stroke Research Berlin
  More Information

No publications provided

Responsible Party: Martin Ebinger, Dr, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01954797     History of Changes
Other Study ID Numbers: BAPTISe, BMBF-G.2.15
Study First Received: September 27, 2013
Last Updated: November 26, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Physical fitness
relaxation
stroke
cerebral ischemia
cerebral perfusion
biomarkers
MRI

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 16, 2014