Strengths and limitations
stroke
ADVERSE EVENTS, STROKE
Our trial was robustly designed, adhered to the CONSORT statement for pilot studies and followed international recommendations for developing and reporting complex interventions.A strength of our trial was the comprehensive reporting and adjudication of adverse events. No serious and only five non-serious adverse events were “definitely related” to the interventions. Most adverse events were reported in the PA and PA + DIET groups, where contact between trial staff and participants was more frequent. In several instances of unrelated adverse events, participants were advised to seek medical review, which led to subsequent intervention. Many people with stroke in Australia do not have routine follow-up with stroke specialists after 3 months, so it is possible that by providing a regular point of contact with health professionals, our trial may have led to benefits for participants beyond the intent of the interventions themselves.