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Table 1 Description of the intervention using the Template for Intervention Description and Replication (TIDieR) Checklist

From: PRehabIlitatiOn with pReoperatIve exercise and educaTion for patients undergoing major abdominal cancer surgerY: protocol for a multicentre randomised controlled TRIAL (PRIORITY TRIAL)

Brief name

PRIORITY TRIAL

Why

Radical surgery is the only treatment option that offers a chance of survival for patients presenting with major advanced or recurrent gastrointestinal cancer. While these procedures significantly improve survival, rates of major postoperative complications remain high. An exercise program to improve physical conditioning before surgery could enhance recovery and reduce postoperative complications among patients undergoing surgery. These patients routinely have a period of 4-8 weeks from first surgical consultation to undergoing the procedure, which provides an opportunity to deliver a tailored, progressive exercise and education program.

What materials?

Participants allocated to the intervention group will receive an individualised exercise and education program during the preoperative period delivered by community-based physiotherapists and exercise physiologists. It’s expected that the physiotherapists and exercise physiologists will use various materials, such as weights, elastic bands, stationary bicycles, treadmills, to deliver the proposed intervention. Further, participants will be encouraged to walk continuously for at least 30 min daily, using an activity monitor (Yamax Power Walker EX-510). Participants from the control group will be given an activity monitor for 1 week before surgery only. This is to measure their objective level of physical activity during the preoperative period. The screen will be blocked with security tape, and all feedback and incentivising features will be deactivated.

What procedures?

INDIVIDUALISED PREOPERATIVE EXERCISE AND EDUCATION PROGRAM (Intervention)

The intervention 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). Each session will include warm-up, aerobic/anaerobic, resistance, respiratory exercises, and cooldown activities:

a. Warm-up (~ 5 min): Low-intensity exercises (e.g., walking, cycling)

b. Exercises (~ 40 min):

i. Aerobic and anaerobic exercises (~ 15-25 min): Cycle ergometer, treadmill, or rowing machine (high-intensity interval training based on their rated perceived exertion – M-Borg scale). This will be adjusted to the response of the patient as they progress through the exercise sessions. Considerable flexibility with the prescription of the high-intensity interval training will be adopted to allow for individual participant responses.

Phase 1 (approximately 2 weeks): Exercise intensity focused on rated perceived exertion of 3 to 5 on the M-Borg Scale continuous 20 min session or 2 × 10 min sessions (Low intensity). This phase is ideal to prepare the patient for Phase 2. Sedentary patient may need to stay in this phase for approximately 2 weeks, while more active patients can move to Phase 2 sooner.

Phase 2 (approximately 2-4 weeks): The intensity and duration of the exercise will be increased gradually. Exercises will be focused on a rated perceived exertion of 3 to 5 on the M-Borg Scale for 30-40 min (Moderate intensity). Once the patients can tolerate the Phase 2 sessions at the abovementioned M-Borg scores, they could progress to interval training at a higher intensity (Phase 3).

Phase 3 (approximately 2-4 weeks): Introduce anaerobic high-intensity interval training at 5 to 8 on the M-Borg Scale (4 high intensity intervals on the M-Borg Scale of 5-8 lasting 4 min each with interval reduction of intensity on the M-Borg Scale of 3-5 for 4 min).

ii. Respiratory exercises (~ 5-10 min): Deep breathing exercises alone or in a cycle with relaxed breathing, huff, and cough (Active Cycle of Breathing Technique).

iii. Resistance exercises (~ 10-20 min): Squat, push-up, shoulder press, hamstrings curl, dumbbell deadlift, biceps curl, and overhead triceps extension (performed at 40-60% of the one-repetition maximum).

c. Cooldown (~ 5 min): Stretching and flexibility exercises (Triceps, lower back, hip flexors, quadriceps, hamstrings, calf muscles, light jogging, walking, or stretching exercises), performed twice for 20-30 s.

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 day’s participants are not attending the exercise training session, they will be instructed to perform the exercises for 30 min at home.

3) Daily physical activity advice: In addition to home exercises, participants will be encouraged to walk continuously for at least 30 min daily, using an activity monitor (Yamax Power Walker EX-510). Participants will be asked to keep a daily diary of the number of steps per day and the number of home exercises performed during the preoperative period. The activity monitor will be provided by the study research team free of charge after the baseline assessment. The device will be collected from the patient at the following assessment (the week before surgery). Step count will be extracted from the activity monitor daily by the participant, and the research team will check all activity monitor data once the device has been returned. Access to this information will be limited to the patient and the research team. Once participation has been completed, the research team will delete all data from the activity monitor. The information stored on the devices will be erased. 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.

USUAL CARE (CONTROL GROUP)

Participants allocated to the control group will receive usual care consisted of nutritional counselling and advice on smoking cessation and reduction of alcohol intake. However, no exercise advice will be provided, and patients will be instructed to maintain their normal daily activities.

Who provided?

The intervention 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 per the study protocol.

How?

The exercise program (supervised, individualised, progressive exercise program) will be individualised and delivered by registered physiotherapists or exercise physiologists. The home exercises will be prescribed by the registered physiotherapists or exercise physiologists and will be conducted at home, unsupervised. Likewise, the registered physiotherapists or exercise physiologists will give the daily physical activity advice to be completed by the participant, unsupervised.

Where?

The intervention will be conducted at private clinics, mainly in Sydney (New South Wales) and Melbourne (Victoria), Australia. However, as the trial is recruiting from major referral hospitals, it is expected that a small proportion of the patients will reside outside of New South Wales and Victoria. Therefore the intervention may also be conducted in private clinics in other Australian states.

When and how much?

The preoperative exercise and education program will be delivered 4-8 weeks before surgery and include: (i) Up to 24 sessions × 50 min: Supervised, high-intensity training. Individualised exercise prescription, progression, and follow-up with a local physiotherapist or exercise physiologist; (ii) Up to 32 sessions × 30 min: Unsupervised home exercise; (iii) Up to 56 walking sessions ×  30 min: Advice to walk continuously (30 min daily).

Tailoring

The exercise program will be tailored to each participant based on a health assessment, considering patients’ current health status, physical activity level, presence of co-morbidities, and medical history.