Trials (Jan 2023)
CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in older people at risk—a multicentre, randomised, parallel-group study
Abstract
Abstract Background This multicentre study explores the effects of pre-operative exercise on physical fitness, post-operative complications, recovery, and health-related quality of life in older individuals with low pre-operative physical capacity scheduled to undergo surgery for colorectal cancer. We hypothesise that this group of patients benefit from pre-operative exercise in terms of improved pre-operative physical function and lower rates of post-operative complications after surgery compared to usual care. Standardised cancer pathways in Sweden dictate a timeframe of 14–28 days from suspicion of cancer to surgery for colorectal cancer. Therefore, an exercise programme aimed to enhance physical function in the limited timeframe requires a high-intensity and high-frequency approach. Methods Participants will be included from four sites in Stockholm, Sweden. A total of 160 participants will be randomly assigned to intervention or control conditions. Simple randomisation (permuted block randomisation) is applied with a 1:1 allocation ratio. The intervention group will perform home-based exercises (inspiratory muscle training, aerobic exercises, and strength exercises) supervised by a physiotherapist (PT) for a minimum of 6 sessions in the pre-operative period, complemented with unsupervised exercise sessions in between PT visits. The control group will receive usual care with the addition of advice on health-enhancing physical activity. The physical activity behaviour in both groups will be monitored using an activity monitor. The primary outcomes are (1) change in physical performance (6-min walking distance) in the pre-operative period and (2) post-operative complications 30 days after surgery (based on Clavien-Dindo surgical score). Discussion If patients achieve functional benefits by exercise in the short period before surgery, this supports the implementation of exercise training as a clinical routine. If such benefits translate into lower complication rates and better post-operative recovery or health-related quality of life is not known but would further strengthen the case for pre-operative optimisation in colorectal cancer. Trial registration ClinicalTrials.gov NCT04878185. Registered on 7 May 2021. https://clinicaltrials.gov/ct2/home
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