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

June 5, 2019 updated by: Alexander H Nave, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 4-weeks
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.
baseline and 4-weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional outcome
Time Frame: 3 months
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
3 months
endothelial function assessment
Time Frame: measurement before and after the 4 weeks intervention
the endothelial function of included patients will be assessed prospectively before and after the 4 week intervention with the Endopat2000 device. First measurement was conducted in January 11th 2014. Results will be correlated with imaging and blood-derived biomarkers as well as differences between intervention groups.
measurement before and after the 4 weeks intervention
Clinical biomarkers including vital Parameters
Time Frame: 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)
systolic and diastolic blood pressure, resting heart rate, body-mass-index, and waist-to-hip-ratio over time compared between study groups
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Martin Ebinger, MD, Center for Stroke Research Berlin
  • Principal Investigator: Alexander H Nave, MD, Center for Stroke Research Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Actual)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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