PHYS Stroke: Physical fitness in subacute stroke

Study Description:
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

Publications:
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. https://dx.doi.org/10.1136/bmj.l5101.

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. https://dx.doi.org/10.1177/17474930211006286.