Enhancing treatment outcomes after gynaecological cancer (ACUMEN): Using exercise to promote health after cancer therapy

The total study period is 24 weeks. It comprises of a 12-week exercise training intervention and a 12-week maintenance period. After participant screening and baseline assessment, participants will be randomised to either the intervention or control group. Participants allocated to the control group will receive standard care and will receive general advice about self-managed exercise, a Fitbit, and the Exercise is Medicine guidelines for gynaecological cancer. Control participants will be asked to wear the Fitbit device to assess physical activity performed over the study period. Participants assigned to the intervention group will received one-on-one supervision by an Accredited Exercise Physiologists or Physiotherapists (AEPP). Goals will be prioritised and set with the participant and the prescription co-designed with the participant, including strategies for relapse prevention and longer-term maintenance. As part of this process, the 12-week exercise training intervention will adhere to the following principles: 1. Participants will be screened for known disease and risk of adverse events due to exercise with the Adult Pre-Exercise Screening System (APSS). 2. The goal is to enhance neuromuscular strength, endurance, balance, flexibility, cardiorespiratory fitness and cardiovascular function. The AEPP will individually tailor exercise to the functional capacity of each participant towards these goals, cognisant of potential restrictions caused by surgical scarring, pain, metastases, lymphoedema, obesity, incontinence or neuropathic problems. 3. Participants will aim for 3 x 60 minute exercise sessions per week, individually prescribed by an Accredited Exercise Physiologist or Physiotherapist (AEPP) based on APSS results and the participant’s limitations, preferences and goals. The session will aim for an aerobic component (up to 40 minutes of moderate-to-high intensity) and resistance component (2 x 6-8 repetitions of major muscle group exercises at >8-10 on the OMNI perceived exertion scale, where 0=extremely easy to 10=extremely hard). Adjustments to exercise dose are dependent upon target cancer outcome/s (including cancer-related fatigue, health-related quality of life, physical function, lymphedema, bone health, and sleep). 4. Supervised aerobic exercise will include but are not limited to a bike ergometer, treadmill, rowing, and cross-trainer. Unsupervised homebased aerobic exercise will be prescribed based on the accessibility of the participant. Walking, stepping, water exercise and cycling are examples of home-based aerobic activity. Dynamic resistance exercises, using both concentric and eccentric muscle contractions of major muscle groups will include, but are not limited to, free-weights, resistance bands, resistance machines, and weight-bearing functional tasks. Priority and focus of exercise will be informed by participant driven goals of exercise and exercise considerations. 5. High-intensity interval aerobic exercise may be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and peak heart rate, and closely monitored by the AEPP. 6. The aerobic exercise intensity will be prescribed based on individual peak heart rate obtained from the cardiorespiratory fitness test. Exercising heart rate will be monitored by the FitBit watch during all exercise training sessions (supervised and home-based). Target heart rate will be prescribed at 40-70% of peak heart rate for moderate intensity exercise and 85-95% of peak heart rate for high-intensity interval exercise. Rating of perceived exertion (RPE) using the Borg scale will also be used to facilitate the prescription of exercise intensity. 7. Participants will aim to complete 36 exercise sessions during the 12-week period (3 exercise sessions per week). If participants are unable to reach the target 36 sessions during the 12 weeks (i.e. they miss sessions due to illness or other commitments), then they will be provided with the option of performing make-up sessions during this 12-week period (i.e. a participant may complete 2 sessions one week, then 4 sessions the following week). Alternatively, participants will be provided with the option of completing as many of the remaining sessions as possible during one additional week, making the intervention 13 weeks in duration (at most) for these participants). Regardless of the number of sessions missed, a maximum of 4 sessions will be performed in the additional week. The sessions will mimic the type of session they have missed i.e. supervised or home-based. 8. For the first six weeks, each participant will receive two supervised gym-based sessions per week at a fully-equipped gymnasium, and one self-managed home-based session per week. 9. In Weeks 7-12, participants will be asked to attend one supervised session per week, and increase their home-based exercise prescription to two times per week for six more weeks. 10. Intervention group attendance and adherence at supervised sessions will be recorded by the intervention AEPP, with unsupervised sessions recorded by the participant and reported weekly to the AEPP. Intervention participants will be asked to wear the FitBit during each exercise session (including at home) to closely monitor adherence to prescribed exercise intensity (heart rate). 11. All exercise sessions will be prescribed, logged and tracked using PhysiTrack©. 12. Intervention and control participants will be asked tocontinuously wear a Fitbit throughout the study. Physical activity will be assessed over seven consecutive days prior to study commencement, and for 7 days each throughout Weeks 12 and 24 to accurately track and compare the intensity of daily physical activities. Unsupervised exercise sessions will also be tracked and logged by the Fitbit 13. The secondary outcome of the project is to assess participants’ confidence in their ability to perform exercise without AEPP supervision between week 13 and week 24 (long-term maintenance). In the 12 week maintenance period, intervention participants will be asked to continue with their home-based exercise sessions. However, no support or feedback will be provided by the AEPP or research team. All participants will be asked to continue to wear the FitBit device during the 12-week maintenance period so exercise can be monitored. Duration and intensity of daily physical activities will be tracked during the monitoring period. Intervention participants will be required to wear a FitBit throughout Weeks 13-24 to accurately track the intensity of daily physical activities, including the unsupervised exercise sessions.