Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial

Completely wrong objective, it should have been to write EXACT aerobic exercise protocols. This is useless. 

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial

BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l5101 (Published 18 September 2019) Cite this as: BMJ 2019;366:l5101

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1. Alexander H Nave, neurological research fellow1 2 3 4,  
2. Torsten Rackoll, research scholar1 5,  
3. Ulrike Grittner, biostatistician4 6,  
4. Holger Bläsing, neurologist7,  
5. Anna Gorsler, neurologist5,  
6. Darius G Nabavi, professor of neurology8,  
7. Heinrich J Audebert, professor of neurology1 2,  
8. Fabian Klostermann, professor of neurology2,  
9. Ursula Müller-Werdan, professor of geriatrics9,  
10. Elisabeth Steinhagen-Thiessen, professor of geriatrics9,  
11. Andreas Meisel, professor of neurology1 2 10,  
12. Matthias Endres, professor of neurology1 2 3 4 10 11,  
13. Stefan Hesse, professor of neurology12,  
14. Martin Ebinger, professor of neurology1 12,  
15. Agnes Flöel, professor of neurology1 13 14

Author affiliations

1. Correspondence to: A Flöel agnes.floeel@med.uni-greifswald.de

• Accepted 23 July 2019

Abstract

Objective To determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke.

Design Multicentre, randomised controlled, endpoint blinded trial.

Setting Seven inpatient rehabilitation sites in Germany (2013-17).

Participants 200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care.

Intervention Participants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment.

Main outcome measures The primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values.

Results Compared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (−5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36).

Conclusions Among moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines.

Trial registration ClinicalTrials.gov NCT01953549.