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

Introduction: Physical inactivity remains common post-stroke. Although behavior change interventions improve physical activity, many require home visits or Internet access. Telephone calls and activity monitors are low-cost telehealth options, but evidence for monitor use post-stroke is limited. Integrating monitors into multifaceted strategies (e.g., the 5As brief intervention from the HEARTS Technical Package) may enhance outcomes. This study aimed to assess the feasibility of the 5As brief intervention with versus without a physical activity monitor and to explore changes in physical activity levels to inform a future randomized controlled trial (RCT).

Methods: This phase 1 feasibility RCT, with concealed allocation and blinded assessments, was conducted in a university laboratory (Belo Horizonte, Brazil). Twenty-four individuals in the chronic phase post-stroke were included (12 per group) and received the 5As brief intervention from the HEARTS Technical Package. The experimental group (EG) additionally used an activity monitor (Mi Band 7® Smartwatch). Outcomes included feasibility indicators and physical activity level, analyzed descriptively.

Results: Trial feasibility was supported by recruitment (36.4%), retention (83.3% in both groups), and high attendance (99.1% in the EG and 97.0% in the CG). No adverse events were reported. Attrition remained a challenge, with 66.7% of EG participants (n=8) and 50.0% of CG participants (n=6) completing all follow-up assessments. Main costs were related to transportation for in-person assessments. Physical activity levels increased clinically in both groups, with a large within-group effect in the EG (Cohen’s d = 1.01) and a moderate effect in the CG (Cohen’s d = 0.76).

Conclusions: Both interventions were feasible and resulted in clinical improvements in physical activity levels post-stroke, with greater effects observed in the EG. These findings support the design of a future, larger RCT, with attention to retention strategies, follow-up procedures, and formal evaluation of the added value of physical activity monitor use.