Secondary prevention of stroke. A telehealth-delivered physical activity and diet pilot randomised trial (ENAbLE-pilot)
Coralie Kym English, Emily Ramage, John Attia, Julie Bernhardt, Bille Bonevski, Meredith Burke, Margaret Galloway, Graeme J Hankey, Heidi Janssen, Richard Lindley, Elizabeth Lynch, Christopher Oldmeadow, Catherine M Said, Neil Spratt, Karly Zacharia, Lesley MacDonald-Wicks, Amanda Patterson- Neurology
- Neurology (clinical)
Background:
Improving physical activity levels and diet quality are important for secondary stroke prevention.
Aim:
To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality.
Methods:
2 x 2 factorial trial (physical activity [PA]; diet [DIET]; PA + DIET; control) randomised, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report physical activity (International Physical Activity Questionnaire [IPAQ]) and diet quality (Australian Recommended Food Score [ARFS]), and quality of life. Between-group differences were analysed using linear mixed models.
Results:
Over 23 months 99 people were screened for participation and 40 (40%) randomised (3 months to 10 years post- stroke, mean age 59 [16] years). Six participants withdrew and an additional 5 were lost to follow-up. Fifteen serious adverse events were reported, none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and nine (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months and 14% at 12 months. Between group 95% confidence intervals showed promising, clinically relevant difference in support of the interventions across the range of physical activity, diet quality and blood pressure outcomes.
Conclusion:
Our telehealth physical activity and diet interventions were safe and feasible and may have led to significant behaviour change.
Trial Registration:
ACTRN12620000189921