PRIME pilot trial: a protocol for a multicentre pilot randomised controlled trial of PRehabilitation In advance of Major Elective surgery (PRIME).

Abstract

Prehabilitation is a promising preoperative intervention to improve patient recovery after surgery. Virtually delivered, home-based programmes represent the most efficient model for prehabilitation delivery. However, virtually delivered prehabilitation interventions remain understudied. This manuscript describes the protocol for a pilot randomised controlled trial (RCT) of a virtually monitored, home-based prehabilitation intervention. We will conduct a pilot RCT comparing the standard of care to a virtually monitored home-based prehabilitation programme in adults undergoing major elective intrathoracic, intra-abdominal or orthopaedic surgery. Outcome assessors will be blinded to treatment allocation. The intervention consists of 3-4 weeks of a multimodal (exercise, nutrition and psychosocial support) prehabilitation programme supported through a mobile application already in use at the Kingston Health Sciences Centre. The primary feasibility outcomes and their targets are: (1) monthly recruitment rate of >20 participants across all centres and (2) mean intervention adherence of >80%. A sample of 120 participants will be adequate to estimate recruitment and adherence rates with acceptable precision. The secondary outcomes include comparisons of complications, mortality, new-onset disability, length of stay, readmission, quality of life, nutritional status and functional capacity between intervention arms. Secondary outcomes will be collected prior to randomisation, 2 days before surgery and 30 days after surgery. Ethical approval has been granted by Clinical Trials Ontario (Project ID: 5495). Results will be disseminated through presentations at scientific conferences, peer-reviewed publications and engagement with traditional and social media. ClinicalTrials.gov (NCT07590141).