NCT06231576

Digital Home-Based Prehabilitation Before Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.

Detailed description

Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.

Conditions

• Cancer Colorectal
• Frailty
• Surgery

Interventions

Type	Name	Description
OTHER	Prehabilitation	* Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines. * Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aerobic capacity and physical endurance. Intensity will be based on the rate of perceived exertion using the Borg scale, a 15-graded scale ranging from very light to very hard. Resistance exercises will target upper/lower body, and abdominal muscles. * Psychological coaching and support: Performed as one interview during inclusion, followed by weekly phone calls by a study nurse coordinator during the preoperative intervention.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2024-01-30
• Last updated: 2024-01-30