Preoperative exercise protocol to aid recovery (PREPARE) in radical cystectomy: a randomized controlled feasibility study

Banerjee, Srijit (2016) Preoperative exercise protocol to aid recovery (PREPARE) in radical cystectomy: a randomized controlled feasibility study. Doctoral thesis, University of East Anglia.

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Radical cystectomy (RC) and urinary diversion is the gold standard treatment for both muscle-invasive urinary bladder cancer and for non-muscle invasive disease refractory to intravescical treatment. This is also one of the most complex urological procedures. Despite improvements in practice, technique and process of care, RC is still associated with significant complications, including death, with wide variability in reported postoperative morbidity and mortality rates ranging from 19% to 64% and 0.8% to 8.3%, respectively.
Cardiopulmonary Exercise Testing (CPET) is a non-invasive measurement of cardio-pulmonary fitness. CPET variables such as anaerobic threshold (AT) and maximal oxygen consumption (VO2 max) have been demonstrated to be reliable predictors of postoperative morbidity, mortality and hospital length of stay (LOS) following major surgery and are helpful in risk stratifying patients. The foundations of enhanced recovery programmes (ERPs), also known as enhanced recovery after surgery or fast-track surgery, were laid down by Kehlet in the 1990s and have received widespread acceptance in various surgical specialities. The principles of these peri-operative strategies are to use a multidisciplinary approach to minimising morbidity. This revolves around a team approach, which includes surgeons, anaesthetists, nurses, physiotherapists, stoma therapists, dieticians and most importantly requires active participation from the patient and their family. The role of exercise training or ‘prehabilitation’ for optimising preoperative physiological function to counter catabolic effects of surgery has received little attention in patients undergoing radical cystectomy (RC). This randomised controlled feasibility study examines whether a short preoperative course of supervised exercise sessions is feasible, well tolerated and whether it can lead to an improvement in cardiopulmonary fitness in patients undergoing RC.
Over a 2 year period patients awaiting RC were randomised to either a control arm or an exercise intervention arm after initial CPET assessment. Patients in the exercise arm
were offered twice weekly supervised exercise sessions preoperatively for 4 weeks, whilst the control arm had standard care. Repeat assessment was performed in both groups at the end of 4 weeks. Feasibility outcomes such as recruitment rate, compliance and adverse events were recorded. Postoperative recovery including complications stratified as per Clavien classification and LOS were also recorded.
112 eligible patients were approached of whom 60 were recruited to the study, with a recruitment rate of 53.5%. Mean age was 72 years (range 52-85 years). Nine (15%) patients did not complete repeat CPET testing. No adverse events were recorded during CPET testing or exercise sessions. Compliance with exercise sessions was satisfactory with patients attending for a median of 8 sessions. Dropout rate from the exercise sessions in the intervention arm was 23.3% (n=11). An analysis of covariance (ANCOVA) showed a statistically significant increase in mean VO2 max in the intervention group when compared to the control group by +1.9ml/kg/min (0.87-3, 95% CI), (p=0.001). AT was also similarly increased by +0.33ml/kg/min (-0.68-1.3, 95%CI) (p=0.5). Mean preoperative VO2 max was found to be significantly higher (p<0.001) in patients who had an uncomplicated recovery (22.04ml/kg/min) when compared to those with complications (Clavien grade I or above) (16.32ml/kg/min). Analysis using Spearman’s rank correlation coefficient demonstrated a negative association between day of discharge from hospital and initial VO2 max (p<0.001) indicating quicker postoperative recovery in patients with higher cardiorespiratory fitness levels.
Although not statistically significant there appears to be a trend with complication rates being higher in the control group (39.28%) compared to the exercise intervention arm (33.3%) (p=0.8)
CPET assessment and exercise training is safe and well tolerated. Patients comply with a supervised exercise regime and there is a measurable improvement in their cardiorespiratory fitness after 4 weeks. The data demonstrates that VO2 max is a reliable predictor of outcomes following RC and can potentially be used to risk-stratify patients preoperatively. Although the study is not adequately powered to fully investigate the results of exercise training on postoperative outcomes, the results are promising, and
suggest the requirement for larger randomised controlled trials to elucidate the role of prehabilitation prior to surgery in this population.

Item Type: Thesis (Doctoral)
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
Depositing User: Users 7376 not found.
Date Deposited: 18 Oct 2016 14:14
Last Modified: 18 Oct 2016 14:14


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