EXPRESS: Physical Exercise in Patients with Subacute Stroke (PHYS-STROKE): safety analyses of a randomized clinical trial

 Well it better be safe, your doctor expects you do do physical exercise as much as possible. All because your doctor did nothing in the first week causing billions of neurons to die.

EXPRESS: Physical Exercise in Patients with Subacute Stroke (PHYS-STROKE): safety analyses of a randomized clinical trial

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Torsten Rackoll, Alexander Heinrich Nave, Martin Ebinger, ...

First Published March 16, 2021 Research Article 

https://doi.org/10.1177/17474930211006286

Article information

  

Abstract

Background and aim: 

To report the six-month safety analyses among patients enrolled in the ‘Physical Fitness Training in Subacute Stroke – PHYS-STROKE’ trial and identify underlying risk factors associated with serious adverse events (SAE).

Methods: 

We performed a pre-specified safety analysis of a multicenter, randomized controlled, endpoint-blinded trial comprising 200 patients with moderate to severe subacute stroke (days 5-45 after stroke) that were randomly assigned (1:1) to receive either aerobic, bodyweight supported, treadmill-based training (n=105) or relaxation sessions (n=95, control group). Each intervention session lasted for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. SAE defined as cerebro- and cardiovascular events, readmission to hospital, and death were assessed during six months of follow-up. Incident rate ratios (IRR) were calculated and Poisson regression analyses were conducted to identify risk factors for SAE and to test the association with aerobic training.

Results: 

Six months after stroke, 50 SAE occurred in the trial with a higher incidence rate (per 100 patient-months) in the training group compared to the relaxation group (6.31 vs 3.22; IRR 1.70, 95% CI 0.96 to 3.12). The association of aerobic training with SAE incidence rates were modified by diabetes mellitus (IRR for interaction: 7.10, 95% CI 1.56 to 51.24) and by atrial fibrillation (IRR for interaction: 4.37, 95% CI 0.97 to 31.81).

Conclusions: 

Safety analysis of the PHYS-STROKE trial found a higher rate of SAE in patients randomized to aerobic training compared to control within six months after stroke. Exploratory analyses found an association between SAE occurrence in the aerobic training group with pre-existing diabetes mellitus and atrial fibrillation which should be further investigated in future trials.

Data access statement: 

The raw data and analyses scripts are provided by the authors on a secure online repository for reproduction of reported findings.

Keywords Aerobic treadmill training, Risk factors, safety, serious adverse events, stroke rehabilitation, subacute stroke

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