PHYS Stroke: Physical fitness in subacute stroke
Given the rising number of strokes worldwide, and the large number of individuals left with disabilities after stroke, novel strategies to reduce disability, increase functions in the motor and the cognitive domains, and improve quality of life are of major importance. Physical activity is a promising intervention to address these challenges but, as yet, there is no study demonstrating definite outcomes. Our objective was to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes, in particular gait speed and the Barthel Index (co-primary outcome measures) reflecting activities of daily living (ADL). We gathered secondary functional outcomes as well as mechanistic parameters in an exploratory approach. The ultimate goal of this endpoint-blinded, phase III randomised controlled trial was to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention.
Principle Investigator: Prof. Dr. med. Agnes Flöel (Cognitive Neurology, NCRC, Neurology CCM)
Registration: This study is registered in the database clinicaltrials.gov (NCT01953549).
Course of the study: 11/2013 - 11/2017
Nave, A. H., T. Rackoll, U. Grittner, H. Blasing, A. Gorsler, D. G. Nabavi, H. J. Audebert, F. Klostermann, U. Muller-Werdan, E. Steinhagen-Thiessen, A. Meisel, M. Endres, S. Hesse, M. Ebinger, and A. Floel. "Physical Fitness Training in Patients with Subacute Stroke (Phys-Stroke): Multicentre, Randomised Controlled, Endpoint Blinded Trial." BMJ 366 (Sep 18 2019): l5101. Link
Rackoll, T., A. H. Nave, M. Ebinger, M. Endres, U. Grittner, A. Floel, and Phys-Stroke study group for the. "Physical Fitness Training in Patients with Subacute Stroke (Phys-Stroke): Safety Analyses of a Randomized Clinical Trial." Int J Stroke (Apr 7 2021): 17474930211006286. Link
Floel, A., C. Werner, U. Grittner, S. Hesse, M. Jobges, J. Knauss, M. Seifert, E. Steinhagen-Thiessen, M. Govercin, C. Dohle, W. Fischer, R. Schlieder, A. H. Nave, A. Meisel, M. Ebinger, and I. Wellwood. "Physical Fitness Training in Subacute Stroke (Phys-Stroke)--Study Protocol for a Randomised Controlled Trial." Trials 15 (Feb 03 2014): 45. Link
Jodicke, R. A., S. Huo, N. Krankel, S. K. Piper, M. Ebinger, U. Landmesser, A. Floel, M. Endres, and A. H. Nave. "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 12 (2021): 731013. Link
Kirzinger, B., A. Stroux, T. Rackoll, M. Endres, A. Floel, M. Ebinger, and A. Nave. "The Dynamics of Serum Inflammatory Markers in Subacute Stroke and Associations with Aerobic Fitness Training and Clinical Outcome: Results of the Randomized Controlled Phys-Stroke Trial." Meeting Abstract, International Journal of Stroke 16, no. 2_SUPPL (Oct 2021): 33-34. <Go to ISI>://WOS:000712442200121.
Kirzinger, B., A. Stroux, T. Rackoll, M. Endres, A. Floel, M. Ebinger, and A. H. Nave. "Elevated Serum Inflammatory Markers in Subacute Stroke Are Associated with Clinical Outcome but Not Modified by Aerobic Fitness Training: Results of the Randomized Controlled Phys-Stroke Trial." Front Neurol 12 (2021): 713018. Link
Müller, S., A. Kufner, A. Dell'Orco, T. Rackoll, R. Mekle, S. K. Piper, J. B. Fiebach, K. Villringer, A. Flöel, M. Endres, M. Ebinger, and A. H. Nave. "Evolution of Blood-Brain Barrier Permeability in Subacute Ischemic Stroke and Associations with Serum Biomarkers and Functional Outcome." Front Neurol 12 (2021): 730923. Link