Physical fitness training in Subacute Stroke (PHYS-STROKE)--study protocol for a randomised controlled trial.
BACKGROUND
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 is 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 will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach.


METHODS
Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45 days after stroke onset. Participants will be stratified for the prognostic variables of "centre", "age", and "stroke severity", and randomly assigned to one of two groups. The interventional group receives physical fitness training delivered as supported or unsupported treadmill training (cardiovascular active aerobic training; five times per week, over 4 weeks; each session 50 minutes; total of 20 additional physical fitness training sessions) in addition to standard rehabilitation treatment. The control intervention consists of relaxation sessions (non-cardiovascular active; five times per week week, over 4 weeks; each session 50 minutes) in addition to standard rehabilitation treatment. Co-primary efficacy endpoints will be gait speed (in m/s, 10 m walk) and the Barthel Index (100 points total) at 3 months post-stroke, compared to baseline measurements. Secondary outcomes include standard measures of quality of life, sleep and mood, cognition, arm function, maximal oxygen uptake, and cardiovascular risk factors including blood pressure, pulse, waist-to-hip ratio, markers of inflammation, immunity and the insulin-glucose pathway, lipid profile, and others.


CONCLUSIONS
The goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention.


BACKGROUND
Registered in ClinicalTrials.gov with the Identifier NCT01953549.
Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany. agnes.floeel@charite.de.
Agnes
A
Flöel
Cordula
C
Werner
Ulrike
U
Grittner
Stefan
S
Hesse
Michael
M
Jöbges
Janet
J
Knauss
Michael
M
Seifert
Elisabeth
E
Steinhagen-Thiessen
Mehmet
M
Gövercin
Christian
C
Dohle
Wolfgang
W
Fischer
Regina
R
Schlieder
Alexander Heinrich
AH
Nave
Andreas
A
Meisel
Martin
M
Ebinger
Ian
I
Wellwood
D000203:Activities of Daily Living; D000367:Age Factors; D002985:Clinical Protocols; D004185:Disability Evaluation; D005080:Exercise Test; D005081:Exercise Therapy; D005684:Gait; D005858:Germany; D006801:Humans; D010809:Physical Fitness; D020127:Recovery of Function; D012107:Research Design; D012720:Severity of Illness Index; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking