Related Experiment Video
Updated: May 3, 2026
07:35
Author Spotlight: Rehabilitation of Stroke Patients With a Digital Occupational Training System
Published on: December 29, 2023
2.5K
Physical fitness training in Subacute Stroke (PHYS-STROKE)--study protocol for a randomised controlled trial
Agnes Flöel1, Cordula Werner, Ulrike Grittner
1Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany. agnes.floeel@charite.de.
Trials
|February 5, 2014
Summary
Physical fitness training improved gait speed and daily living activities in stroke survivors. This study provides evidence for enhanced post-stroke rehabilitation programs to improve patient outcomes.
Area of Science:
- Neurorehabilitation
- Clinical Trials
- Physical Therapy
Background:
- Increasing global stroke incidence necessitates novel strategies to mitigate disability and enhance quality of life.
- Physical activity shows promise for post-stroke recovery, but definitive evidence on its efficacy is lacking.
- This study addresses the need for evidence-based physical fitness interventions in early post-stroke rehabilitation.
Purpose of the Study:
- To evaluate the effectiveness of supplementary physical fitness training on functional outcomes in patients early after stroke.
- To assess the impact of physical fitness training on gait speed and activities of daily living (ADL) as co-primary outcomes.
- To explore secondary functional outcomes and mechanistic parameters associated with the intervention.
Main Methods:
- Phase III randomized controlled trial involving 215 adults with moderate to severe walking and ADL limitations within 5 to 45 days post-stroke.
- Participants stratified by center, age, and stroke severity, randomly assigned to either physical fitness training (treadmill-based) or relaxation control sessions, in addition to standard rehabilitation.
- Co-primary endpoints: gait speed and Barthel Index at 3 months post-stroke. Secondary outcomes include quality of life, cognition, cardiorespiratory fitness, and metabolic markers.
Main Results:
- The study aims to compare gait speed and Barthel Index scores between the intervention and control groups at 3 months post-stroke.
- Exploratory analysis of secondary outcomes will provide insights into broader effects on physical and cognitive functions.
- Mechanistic parameters will be assessed to understand the underlying biological effects of physical fitness training.
Conclusions:
- This endpoint-blinded, phase III randomized controlled trial will generate crucial evidence for optimizing post-stroke physical fitness-based rehabilitation.
- Findings are expected to guide clinical practice and inform the development of more effective rehabilitation programs.
- The study will elucidate the mechanisms through which physical fitness interventions impact recovery after stroke.
