Journal Article

Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surgery in improving cognitive and functional outcomes for older adults

Pandharipande, Pratik P, Jackson, Jim C, Raman, Rameela, Ellison, Terri, Lauck, Alana, Provin, Madison, Vanston, Susan W, Archer, Kristin R, Hughes, Christopher G, Orun, Onur M, Ervin, Hope, Rengel, Kimberly F

2026

Overview

IntroductionSurgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.Methods and analysisThe COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.Ethics and disseminationTrial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.Trial registration numberClinicalTrials.gov Registry NCT04889417.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Activities of daily living / Aged / Biomarkers / Clinical trials / Cognition / Cognition & reasoning / Cognitive dysfunction / Cognitive Enhancement / Cognitive Training - methods / Exercise / Exercise Therapy - methods / Female / GERIATRIC MEDICINE / Humans / Postoperative Complications - prevention & control / Preoperative Exercise / Protocol / Public health / Randomized Controlled Trial / Randomized Controlled Trials as Topic / REHABILITATION MEDICINE / Surgery / Surgical Procedures, Operative - rehabilitation / United States