Secondary Prevention of Stroke: Study Protocol for a Telehealth-Delivered Physical Activity and Diet Pilot Randomized Trial (ENAbLE-Pilot)

Abstract

<b><i>Background:</i></b> Increasing physical activity (PA) and improving diet quality are opportunities to improve secondary stroke prevention, but access to appropriate services is limited. Interventions co-designed with stroke survivors and delivered by telehealth are a potential solution. <b><i>Aim:</i></b> The aim of this study is to test the feasibility, safety, and potential efficacy of a 6-month, telehealth-delivered PA and/or dietary (DIET) intervention. <b><i>Methods:</i></b> Pilot randomized trial. 80 adults with previous stroke who are living at home with Internet access and able to exercise will be randomized in a 2 × 2 factorial (4-arm) pilot randomized, open-label, blinded outcome assessment trial to receive PA, DIET, PA + DIET, or control interventions via telehealth. The PA intervention aims to support participants to meet the minimum recommended levels of PA (150 min/week moderate exercise), and the DIET intervention aims to support participants to follow the AusMed (Mediterranean-style) diet. The control group receives usual care plus education about PA and healthy eating. The co-primary outcomes are feasibility (proportion and characteristics of eligible participants enrolled and proportion of scheduled intervention sessions attended) and safety (adverse events) at 6 months. The secondary outcomes include recurrent stroke risk factors (blood pressure, physical activity levels, and diet quality), fatigue, mood, and quality of life. Outcomes are measured at 3, 6, and 12 months. <b><i>Conclusion:</i></b> This trial will produce evidence for the feasibility, safety, and potential effect of telehealth-delivered PA and DIET interventions for people with stroke. Results will inform development of an appropriately powered trial to test effectiveness to reduce major risk factors for recurrent stroke. <b><i>Trial registration:</i></b> ACTRN12620000189921.

Mobile health to promote physical activity in people post stroke or transient ischemic attack – study protocol for a feasibility randomised controlled trial

“…This study is an extension to an existing telehealth-delivered programme (i-REBOUND– Let’s get moving) developed in Australia [ 32 , 33 ] which provides support for home-based physical exercise and physical activity through behaviour change techniques to people post stroke or TIA via video meetings (i.e., “Zoom”). [ 34 ].…”

Mixed methods evaluation to explore participant experiences of a pilot randomized trial to facilitate self‐management of people living with stroke: Inspiring virtual enabled resources following vascular events (iVERVE)

“…31 People with stroke have reported interest in the use of technology for health information and self-management, 32,33 indicating a promising potential alternative to more traditional means of face-to-face education and care provision. The focus on using technology in stroke is further emphasized by a number of published protocols integrating text messages, emails or use of applications into interventions to increase physical activity and improve diet, 34 and focus on stroke prevention and self-management ability, 35 or reduce poststroke depression. 36 There are few studies with interventions that have included person-centred goal setting with aligned digital health support.…”

The Impact of the COVID-19 Pandemic on Physical Activity, Function, and Quality of Life

“…47 Evidence for other groups such as stroke is more limited 48,49 ; however, a large number of trials have evaluated the feasibility of using telehealth to deliver exercise, with more underway. [50][51][52][53][54] It is essential that mechanisms to support the delivery of physical activity interventions via telehealth to older people are considered and that the effectiveness of telehealth interventions are rigorously evaluated.…”