Preoperative exercise and education for patients undergoing major abdominal cancer surgery: A multicentre randomised controlled trial (PRIORITY Trial)

The program will be delivered by trained clinicians in existing community facilities (e.g. physiotherapists or exercise physiologists close to participant home). We have deliberately chosen to position the study in a real world setting to ensure that the results will reflect what could be readily achieved in Australia and be more rapidly translated into clinical practice. Participants will be allocated to an individualised progressive preoperative exercise and education program (intervention group) or usual care alone (control group). All patients will undergo a baseline assessment prior to being randomised into either the preoperative exercise and education program (intervention) or usual care (control), and assessment week prior to surgery. The baseline and week before surgery assessments will collect subjective data with a self-reported questionnaire (measuring Duke Activity Status Index (DASI), Quality of life (SF-36v2), Physical Activity Questionnaire, Numerical Pain Rating Scale (NPRS) and Fatigue Severity Scale (FSS) and objective data with an assessment (includes a cardiorespiratory exercise test (CPET), a five times sit to stand test (5TSTS) and six minute walk test (6MWT)), for approximately one hour. Due to pandemic restrictions at the participating centres, the 5TSTS test will be performed by a trained clinician via video call in patients own home. The CPET and 6MWT assessments will be restricted and not uniformly assessed to all participants. Individualised preoperative exercise and education program (Intervention group) The main aim of the exercise program is to increase aerobic capacity and peripheral muscle endurance, muscle strength and respiratory muscle function and to educate participants to perform the exercise at home and about the surgical process. The individualised exercise program will follow the FITT-VP (frequency, intensity, time, type, volume and progression) principle suggested by the American College of Sports Medicine and will be delivered using three main components: 1) Supervised, individualised, progressive exercise program: The exercise program will consist of a 50-min individualised (one-to-one) training session with a physiotherapist or exercise physiologist, three times a week, for 4 to 8 weeks (range from 12 to 24 sessions). The exercise program will be tailored to each patient based on a health assessment, taking into consideration patients’ current health status, physical activity level, presence of co-morbidities and medical history. Each session will include warm-up (walking, cycling), aerobic/anaerobic exercises (cycle ergometer, treadmill, rowing machine, marching or running on the spot), resistance exercises (squat, push-up, shoulder press, hamstring curls, dumb-bell deadlift, biceps curl and overhead triceps extension), respiratory exercises (Deep breathing, relaxed breathing huff and cough (ABCT)), and cool-down activities (triceps, lower back, hip flexors, quadriceps, hamstrings, calf muscles, light jogging, walking or stretching). The aerobic exercises will be based on the individuals rated perceived exertion (modified Borg Scale) and the resistance training will be performed at an intensity of 40% to 60% of the 1-repetition maximum. 2) Home exercises (4 times/week): Home-based functional exercises will be prescribed by the treating physiotherapist or exercise physiologist to increase aerobic capacity and respiratory muscle function, including exercises with resistance provided by bodyweight, including push ups, squats, step ups. On the days participants are not attending the one-on-one training session, they will be instructed to perform the exercises for 30 minutes at home. 3) Daily physical activity advice: In addition to home exercises, participants will be encouraged to walk continuously for at least 30 minutes daily using an activity monitor. Participants will be asked to keep a daily diary of the number of steps per day and number of home exercises performed during the entire preoperative period. Step count will be extracted from the activity monitor daily by the participant, and all activity monitor data will be checked by the research team once the device has been returned. The access to this information will be limited to you and the research team. Once participation have been completed, the research team will delete all data from the activity monitor. The information stored on the activity monitor will be erased completely. No one, apart from the study investigators will have access to the data collected. No data collected from the activity monitor will be sent to any of the involved institutions. The results from the study will not be used to register the activity monitor. The preoperative exercise program is 4-8 weeks, leading up to a week prior to the patients' surgery and includes: - Up to 24 sessions x 50 minutes: Supervised, high-intensity training. Individualised exercise prescription, progression and follow-up with local physiotherapist or exercise physiologist either face-to-face or via tele-health. - Up to 24 sessions x 30 minutes: Unsupervised home exercise. - Up to 56 walking sessions x 30 minutes: Advice to walk continuously (30 minutes daily). Treatment will be administered by local registered physiotherapists or exercise physiologists who will educate and provide high-intensity interval training, home exercises prescription and progression and physical activity advice in accordance with the study protocol. The adherence to the exercise program will be encouraged by the treating physiotherapist or exercise physiologist and by a team member that will message and/or call patients to check their compliance (i.e. log book).