Physical activity is a key component of secondary stroke prevention. Mobile health (mHealth) interventions show promise for enhancing post-stroke physical activity, but most studies have combined mHealth with onsite services. This study evaluated the feasibility and acceptability of a fully digitalised mHealth intervention for physical activity among individuals post stroke or transient ischemic attack (TIA) in Sweden. In this two-arm feasibility randomised controlled trial, adults with stroke or TIA were randomised to one of the following six month interventions: i) the experiment group, receiving mHealth delivered supervised exercise (two sessions weekly during months one to three, one session weekly during months four to six) and behavioural change techniques for physical activity (including two individual counselling and six follow-up sessions) or, ii) the control group, receiving two mHealth delivered individual counselling and three follow-up sessions. Feasibility (reach, retention, adherence, fidelity, safety) and acceptability were assessed according to pre-specified progression criteria. Of 114 participants, 105 (92%) completed the 6-month intervention and 102 (89%) completed the 12-month follow-up assessment. The intervention reached individuals from 20 of 21 Swedish regions. Sixty-eight percent of participants had a stroke (of which 96% were mild), 64% were female, and average age was 71 years (SD 9). Ninety-five percent were born in Sweden, had a high level of education (61%) and an average daily step count of 6451 steps. Completion of outcome measures included digital questionnaires (98%), sensor-derived physical activity (92%), and blood pressure monitoring (97%). A total of 1781 supervised exercise sessions were delivered to the experiment group, with an adherence rate of 76%, and adherence to individual counselling and follow-up sessions was 96%. Ninety-five adverse events were recorded, of which 16 were related to the intervention (predominantly pain or muscle soreness) but non-serious. Overall satisfaction with the mobile app was 71%, and 76% of the experiment group believed the app could partly replicate in-person visits. The mHealth intervention was overall feasible and acceptable, however there is a need to develop recruitment procedures to increase diversity of included participants regarding socioeconomic status and physical activity level, prior to a Phase 3 trial. ClinicalTrials.gov (NCT05111951)Keywords: physical activity, mHealth, stroke, TIA, feasibility.
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