The Wessex Fit-4-Cancer Surgery Trial (WesFit): a protocol for a factorial-design, pragmatic randomised-controlled trial investigating the effects of a multi-modal prehabilitation programme in patients undergoing elective major intra-cavity cancer surgery.

Background: Surgical resection remains the primary curative treatment for intra-cavity cancer. Low physical fitness and psychological factors such as depression are predictive of post-operative morbidity, mortality and length of hospital stay. Prolonged post-operative morbidity is associated with persistently elevated risk of premature death. We aim to investigate whether a structured, responsive exercise training programme, a psychological support programme or combined exercise and psychological support, delivered between treatment decision and major intra-cavity surgery for cancer, can reduce length of hospital stay, compared with standard care. Methods: WesFit is a pragmatic , 2x2 factorial-design, multi-centre, randomised-controlled trial, with planned recruitment of N=1560. Participants will be randomised to one of four groups. Group 1 (control) will receive usual pre-operative care, Group 2 (exercise) patients will undergo 2/3 aerobic, high-intensity interval training sessions per week supervised by personal trainers. Group 3 (psychological support) patients are offered 1 session per week at a local cancer support centre. Group 4 will receive both exercise and psychological support. All patients undergo baseline and pre-operative cardiopulmonary exercise testing, complete self-report questionnaires and will be followed up at 30 days, 12 weeks and 12 months post-operatively. Primary outcome is post-operative length-of-stay. Secondary outcomes include disability-adjusted survival at 1-year postoperatively, post-operative morbidity, and health-related quality of life. Exploratory investigations include objectively measured changes in physical fitness assessed by cardiopulmonary exercise test, disease-free and overall mortality at 1-year postoperatively, longer-term physical activity behaviour change, pre-operative radiological tumour regression, pathological tumour regression, pre and post-operative body composition analysis, health economics analysis and nutritional characterisation and its relationship to post-operative outcome. Conclusions: The WesFit trial will be the first randomised controlled study investigating whether an exercise training programme +/- psychological intervention results in improvements in clinical and patient reported outcomes in patients undergoing major inter-cavity resection of cancer. ClinicalTrials.gov registration: NCT03509428 (26/04/2018).

The oxygen cost of rehabilitation interventions in mechanically ventilated patients: an observational study.

OBJECTIVE: Early rehabilitation is assumed to be a crucial intervention to facilitate weaning from mechanical ventilation in critically ill patients and to limit their long-term functional dependence. However, little is known about the physiological load imposed on patients during such interventions. Without the ability to quantify the exercise intensity of rehabilitation interventions it is impossible to establish a clear separation between usual care and intervention groups in randomised controlled trials. This may explain the lack of definitive benefit of rehabilitation in published trials. We sought to characterise the physiological load, measured as oxygen consumption (V˙O2), of the physical activities carried out during rehabilitation interventions in mechanically ventilated participants. DESIGN: Observational study. SETTING: Single centre medical-surgical university hospital ICU. PARTICIPANTS: 26 mechanically ventilated participants ventilated >7 days, able to participate in a rehabilitation program. INTERVENTION: Oxygen consumption (measured by the Medgraphics Ultima breath-by-breath gas exchange analysis system) and heart rate were measured continuously pre-, during and post-standard rehabilitation sessions. RESULTS: 52 sessions were recorded in 26 participants. There was considerable variation in the oxygen cost of the physical activities between participants. The recovery time for 1 in 4 rehabilitation sessions was longer than the rehabilitation activity time. CONCLUSIONS: Absolute exercise intensity in mechanically ventilated ICU participants, as measured by oxygen consumption, is not activity-dependent.