The CanMoRe trial – evaluating the effects of an exercise intervention after robotic-assisted radical cystectomy for urinary bladder cancer: the study protocol of a randomised controlled trial

Abstract

Background: Patients who have undergone radical cystectomy for urinary bladder cancer are not sufficiently physically active and therefore may suffer complications leading to readmissions. A physical rehabilitation programme early postoperatively might prevent or at least alleviate these potential complications and improve physical function. The main aim of the CanMoRe trial is to evaluate the impact of a standardised and individually adapted exercise intervention in primary health care to improve physical function (primary outcome) and habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications in patients undergoing robotic-assisted radical cystectomy for urinary bladder cancer. Methods: In total, 120 patients will be included and assigned to either intervention or control arm of the study. All patients will receive preoperative information on the importance of early mobilisation and during the hospital stay they will follow a standard protocol for enhanced mobilisation. The intervention group will be given a referral to a physiotherapist in primary health care close to their home. Within the third week after discharge, the intervention group will begin 12 weeks of biweekly exercise. The exercise programme includes aerobic and strengthening exercises. The control group will receive oral and written information about a home-based exercise programme. Physical function will serve as the primary outcome and will be measured using the Six-minute walk test. Secondary outcomes are gait speed, handgrip strength, leg strength, habitual physical activity, health-related quality of life, fatigue, psychological wellbeing and readmissions due to complications. The measurements will be conducted at discharge (i.e. baseline), post-intervention and 1 year after surgery. To evaluate the effects of the intervention mixed or linear regression models according to the intention to treat procedure will be used.

Does the introduction of pre‐operative cardiopulmonary exercise testing in radical cystectomy delay or alter surgical care?

“…2,5,10 For radical cystectomy, post-operative functional performance has also been found to correlate with overall survival. 3,11 Patients with a low AT of ≤11-12 ml/kg/min and VE/VCO 2 ≥ 33 appear to be at higher risk of complications and mortality. 2,5 However, the literature is still relatively sparse for CPET in radical cystectomy (either laparoscopic/ robotic or open) compared with other major abdominal surgery, and results have been to some degree divided.…”

“…Radical cystectomies are performed for muscle invasive and high risk or recurrent non‐muscle invasive bladder cancer, a major operation with significant morbidity (significant complications in ~30%, overall complications up to 64%) and a perioperative 90 day mortality rate of 5–8% 1,2 . When adjusted for comorbidity and smoking status, age itself is not deemed a risk factor for post‐operative morbidity/mortality, rather cardiorespiratory fitness status 1–4 …”

“… 1 , 2 When adjusted for comorbidity and smoking status, age itself is not deemed a risk factor for post‐operative morbidity/mortality, rather cardiorespiratory fitness status. 1 , 2 , 3 , 4 …”

“…Studies have suggested poor CPET scores pre‐operatively are correlated with a longer and more morbid length of stay 2,5,10 . For radical cystectomy, post‐operative functional performance has also been found to correlate with overall survival 3,11 . Patients with a low AT of ≤11–12 ml/kg/min and VE/VCO 2 ≥ 33 appear to be at higher risk of complications and mortality 2,5 .…”

“…1,2 When adjusted for comorbidity and smoking status, age itself is not deemed a risk factor for post-operative morbidity/ mortality, rather cardiorespiratory fitness status. [1][2][3][4] CPET is a non-invasive and reproducible method of assessing cardiorespiratory function and reserve through a closely monitored exercise test. Its focus is measuring oxygen uptake (VO 2 ) (and calculating ventilatory equivalent for carbon dioxide [VE/VCO 2 ]) during exercise and the point at which aerobic respiration is supplemented by anaerobic respiration to produce energy (the anaerobic threshold [AT]), which appears to correlate with peri-operative outcomes.…”