Telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke: protocol for a feasibility randomized controlled trial

Introduction: Insufficient physical activity is a common risk factor for recurrent stroke in individuals post-stroke. The HEARTS Technical Package, developed by organizations like the World Health Organization, is a potential resource for promoting physical activity post-stroke. It aligns with secondary stroke prevention recommendations, addresses barriers/facilitators for physical activity post-stroke, and can be implemented remotely. However, evidence about its use to promote physical activity post-stroke by telehealth is absent. Furthermore, while activity monitors are used in physical activity interventions, their effectiveness post-stroke is primarily studied in-person. Therefore, this study aims to investigate whether the telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible, and to estimate parameters for conducting a fully powered randomized controlled trial (RCT).

Methods: A feasibility RCT study, with blinded assessment, assigned 24 individuals post-stroke (diagnosed ≥6 months), who were aged ≥18 years, inactive, able to walk 10 meters independently, and with medical approval to participate in physical activity, to an experimental (n=12) or a control group (n=12). Both groups carried out a theoretically-informed telehealth intervention, for 12 weeks, based on the HEARTS Technical Package. The experimental group had additional use of an activity monitor.

Results: The outcomes include the feasibility of recruitment, intervention, and measurement, as well as clinical outcomes.

Conclusions: The proposed intervention meets secondary stroke prevention recommendations and will be implemented via telehealth, aiming to overcome barriers to in-person interventions. This study will inform future phases of conducting an RCT.