PRehabilitation In Advance of Major Elective Surgery: A Pilot Randomized Controlled Trial (PRIME Pilot)

The PRIME pilot trial aims to investigate whether a virtually monitored, home-based multimodal prehabilitation is feasible and can improve postoperative outcomes in adult patient populations undergoing major elective intra-thoracic, intra-abdominal, or orthopedic surgery.

The goal of a prehabilitation program is to optimize a patient's health status before surgery to reduce postoperative morbidity and enhance recovery. Despite advances in perioperative care, postoperative morbidity remains high, particularly in frail, obese, or older populations. Multimodal prehabilitation which includes physical exercise, nutritional optimization, and psychological support has demonstrated potential benefits in small trials and feasibility studies, yet definitive evidence remains limited. Intensive in-person prehabilitation, though effective, is not feasible for most centers due to resource limitations. Conversely, home-based programs, while pragmatic, have shown inconsistent adherence and outcomes. This study proposes a virtually monitored, home-based multimodal prehabilitation program designed to balance feasibility, adherence, and effectiveness, using the CloudDX® remote monitoring platform. The program includes exercise prescriptions, nutritional support, mindfulness exercises, and participant accountability through app-based monitoring.

The study will be conducted as a multicenter pilot randomized controlled trial at Kingston Health Sciences Centre, The Ottawa Hospital, and Hamilton Health Sciences. A total of 120 adult patients scheduled for major elective intra-thoracic, intra-abdominal, or orthopedic surgery will be randomized 1:1 to receive either standard preoperative care or the multimodal prehabilitation intervention. Participants in the intervention group will complete baseline questionnaires and receive prehabilitation consultation and education after onboarding to the CloudDX virtual platform using a cellular-enabled tablet provided to them, or their own device. The structured prehabilitation activities will be completed over a minimum of three weeks before surgery.

Primary objectives focus on feasibility, specifically recruitment rates and adherence to the intervention. Adherence will be tracked via the CloudDX® platform. Secondary objectives include assessing the program's impact on postoperative complications (using the Comprehensive Complication Index), mortality, disability (WHODAS 2.0), length of hospital stay, readmission rates, functional capacity (6-Minute Walk Test, CHAMPS, grip strength), quality of life (EQ-5D-5L), and nutritional status (PG-SGA).

Data will be collected through patient interaction, app-based monitoring, and medical record review. All study personnel will receive standardized training, and a detailed Manual of Operations will guide procedures at all sites. Data will be entered into a secure, REDCap electronic database using study-specific IDs, with source documents retained for verification. To ensure data quality, the Project Office will review monthly reports on enrollment, follow-up, and data completeness. The database will have built-in validity and range checks, with multi-level data validation and regular quality control reports shared with sites. All study records will be stored securely for at least five years post-study, with controlled access. Additionally, case histories with records of all observations and data related to the investigation will be maintained for each participant. Data will be reported on a hard copy case report form as well as being entered onto online database.