But you didn't do it correctly. What is the safety profile of the amount of exercise to get 100% recovered? DO YOU NOT UNDERSTAND THE ONLY GOAL IN STROKE IS 100% RECOVERY? Not this tyranny of low expectations you insist upon doing. What is your justification for doing crapola research instead of useful research to 100% recovery?
Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial
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.
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 min, five times weekly for four weeks, in addition to standard rehabilitation therapy. Serious adverse events 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 serious adverse events and to test the association with aerobic training.
Results
Six months after stroke, 50 serious adverse events 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 serious adverse events 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 serious adverse events in patients randomized to aerobic training compared to control within six months after stroke. Exploratory analyses found an association between serious adverse events occurrence in the aerobic training group with pre-existing diabetes mellitus and atrial fibrillation which should be further investigated in future trials.
Introduction
The number of stroke survivors with impairments is increasing, rendering effective rehabilitation interventions a major unmet medical need.1 Aerobic training is a recommended treatment modality in stroke rehabilitation to counter cardiorespiratory deterioration.2–4 However, it remains uncertain whether training in the critical early period of stroke recovery can be carried out safely. Cardiorespiratory stress applied during early rehabilitation might cause adverse effects.5
The evidence of safety of aerobic training early after stroke is scarce. The latest Cochrane Collaboration meta-analysis aggregated estimates of adverse effects including cerebro- and cardiovascular events in the stroke population but could not identify a higher risk in aerobic training compared to control interventions.6 Of note, the evidence derived mainly from small studies with limited reporting of adverse events.
Surprisingly and in contrast to smaller stroke rehabilitation trials, the results of the recent “Physical Fitness Training in Subacute Stroke” (PHYS-STROKE) trial,7 which randomized subacute stroke patients to early aerobic training or relaxation, identified a higher risk of serious adverse events (SAE) within three months post stroke in the training group compared to control.
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