Prehabilitation Before Major Surgery

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.

Descriptive statistics (means, medians, standard deviations, interquartile ranges, proportions) will be used to characterize the study sample. The outcomes of the pilot study will be descriptive in nature and will focus on feasibility measures, including recruitment, adherence, case report form completion, patient satisfaction, and withdrawal rates. Binary outcomes will be summarized using proportions with corresponding 95% confidence intervals. Differences in continuous outcomes will be described using the difference in means with corresponding 95% confidence intervals. All analyses will follow intent-to-treat (ITT) principles, with the ITT population defined as all randomized participants. Baseline characteristics will be summarized descriptively.

The study will be conducted in compliance with the protocol, principles laid down in the Declaration of Helsinki, Good Clinical Practice (GCP), as defined by the International Conference on Harmonisation (ICH), and all applicable laws and regulations of Canada.

By addressing the critical gap in accessible prehabilitation services, this trial aims to establish a scalable model that can be integrated across Canadian healthcare settings. The results of this pilot will inform the design and conduct of a larger definitive randomized trial.

• Postoperative complications [Time frame: 30 days post-surgery]
• Mortality [Time frame: 30 days post-surgery]
• Disability [Time frame: 30 days post-surgery]
• Length of stay and readmission [Time frame: Length of stay: From day of surgery to date of documented discharge, assessed up to 30-days after surgery. Readmission: From day of surgery until date of first documented hospital readmission, assessed up to 30-days post-surgery]
• European Quality of Life 5 Dimensions 5 Level Version (EQ5D5L) [Time frame: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery]
• Nutritional Status [Time frame: Assessed at each major assessment point throughout the study. (1) Baseline - Day 0 (2) 2 days prior to surgery (3) 30 days after surgery]
• Percentage of patients approached that are subsequently enrolled [Time frame: From initial patient approach until enrolment is completed]
• Case Report Form Completion [Time frame: From enrolment until final data entry for each participant.]
• Patient Satisfaction With Prehabilitation Program [Time frame: After the 3 week prehabilitation program; before surgery]
• Proportion of Participants Who Withdraw Consent to Participate [Time frame: From enrolment until final study follow-up (30 days postoperative).]
• 6-Minute Walk Test Distance [Time frame: (1) Baseline (2) 2-days prior to surgery (3) 30-days after surgery]
• Self-reported physical activity [Time frame: (1) baseline (2) 2-days prior to surgery (3) 30-days after surgery]