Home-based, virtually supported multimodal prehabilitation compared with usual care prior to major surgery: a multicentre, pragmatic pilot randomised trial

AbstractBackground A pragmatic, multicentre randomised trial of virtually supported, home-based prehabilitation is required to evaluate effectiveness in generalisable settings; however, feasibility is unknown. Methods This was a pragmatic, parallel-arm, multicentre internal pilot randomised controlled trial. Adults aged 18 years or older preparing for planned, inpatient non-cardiac, non-orthopaedic surgery were recruited from surgeons' offices at five Canadian centres (30 January to 11 July 2024). Participants were randomised to a virtually supported home-based prehabilitation programme (exercise, protein supplementation, psychosocial support) delivered by trained coaches using a theory-based approach, or to usual care. Feasibility outcomes were recruitment (target >6 participants/centre/month), adherence (>75%), and outcome completeness (>90%). Barriers and facilitators were assessed using a validated Theoretical Domains Framework (TDF) survey. Cluster analyses explored patterns of TDF responses and associations with adherence. Results We randomised 144/154 eligible participants (93.5%; recruitment rate: 8.4, standard deviation sd 4.4 participants/center/month). The mean participant age was 62 (sd 12, range 28–85). Trial-level median adherence was 95% (inter-quartile range 73–100), and 57 (78.5%) participants achieved >75% adherence. Patient-reported outcomes were complete for 137 (95.1%) participants at 30 days, 136 (94.4%) at 90 days, and 129 (89.5%) at 365 days after operation. Participants identified beliefs about consequences and capabilities, intentions, and social roles as facilitators. Environmental context and emotions were barriers. Participants' TDF response profiles clustered in three groups. Cluster membership was strongly associated with adherence (PConclusions A pragmatic, multicentre trial of virtually supported home-based multimodal prehabilitation is feasible. Findings support progression to a fully powered trial. Observed associations between perceived barriers, facilitators, and adherence should be validated. Trial registration ClinicalTrials.gov NCT06042491.