Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial).

BACKGROUND: There is a need for evidence of the effectiveness of pre-operative exercise for patients undergoing major cancer surgery; however, recruitment to such trials can be challenging. The PrE-operative Physical Activity (PEPA) Trial will establish the feasibility and acceptability of a pre-operative exercise programme aimed to improve patient outcomes after cytoreductive surgery and pelvic exenteration. The secondary aim is to obtain pilot data on the likely difference in key outcomes (post-operative complications, length of hospital stay, post-operative functional capacity and quality of life) to inform the sample size calculation for the substantive randomised clinical trial.

METHODS/DESIGN: Twenty patients undergoing cytoreductive surgery and pelvic exenteration at the Royal Prince Alfred Hospital, Sydney will be recruited and randomly allocated (1:1 ratio) to either 2 to 6 weeks' pre-operative exercise programme (intervention group) or usual care (control group). Those randomised to the intervention group will receive up to six individualised, 1-h physiotherapy sessions (including aerobic and endurance exercises, respiratory muscle exercises, stretching and flexibility exercises), home exercises (instruction and recommendations on how to progress the exercises at home) and encouragement to be more active by using an activity tracker to measure the number of steps walked daily. Patients allocated to the control group will not receive any specific advice about exercise training. Feasibility will be assessed with consent rates to the study, and for the intervention group, retention and adherence rates to the exercise programme. Acceptability of the exercise programme will be assessed with a semi-structured questionnaire. The following measures of the effectiveness of the intervention will be collected at baseline (2 to 6 weeks pre-operative), a week before surgery, during hospital stay and pre hospital discharge: post-operative complication rates (Clavien-Dindo), post-operative functional capacity (Six-minute Walk Test) and quality of life (SF-36v2®) and length of hospital stay. Functional status will be additionally measured using Cardiopulmonary Exercise Testing (CPET), at baseline and within a week before surgery.

DISCUSSION: The PEPA Trial will provide important information about the feasibility and acceptability of a pre-operative exercise programme for patients undergoing major cancer surgery. Data from the PEPA Trial will be used to inform the design, methodology and to calculate sample size required for a larger, definitive trial.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ID: ACTRN12617001129370 . Registered on 1 August 2017.