ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000214134

Ethics application status

Approved

Date submitted

24/01/2019

Date registered

14/02/2019

Date last updated

2/11/2021

Date data sharing statement initially provided

14/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Preoperative exercise therapy for patients with cancer: A randomised-controlled trial

Scientific title

Feasibility and effectiveness of preoperative exercise therapy for patients with cancer in the Grampians region of Victoria: A randomised-controlled trial

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

The PROTECT Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer

Colorectal Cancer

Breast Cancer

Condition category

Condition code

Cancer

Breast

Cancer

Prostate

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Phase 1 Randomised-controlled trial. Following the completion of written informed consent, participants will be stratified (by cancer type) and randomised (1:1) to one of two groups consisting of: a) the prehabilitation intervention group or b) usual care group.

The intervention will consist of a supervised exercise training session by an accredited exercise physiologist once every three days (estimated four weeks) up and until 3-5 days before surgery in a gym setting. If the scheduled date for surgery is > 4 weeks, or is delayed, participants will continue attending supervised exercise training sessions as per the protocol. Each exercise training session will commence and conclude with a 5-minute warm up and cool-down on a self-selected apparatus (treadmill; stationary bicycle; cross-trainer) and can be conducted in a group or individually. All training will be Aerobic and will be conducted predominantly on a cycle ergometer with additional aerobic exercises (e.g. treadmill, step-ups, cross-trainer) will also be used to maintain participant engagement with the program. The prescribed intensity will be set at 40-70% of HRR and/or a rating of perceived exertion of 11-16 (“fairly light” to “hard”; 6 – 20 scale). Exercise training sessions last between 45-60 minutes, which will aim to include approximately 30 minutes of dedicated aerobic training.

The Accredited Exercise Physiologist who is training the participants may make amendments to the training protocol on an individual basis. However, the exercise sessions will be delivered in a group setting based on particpants availbility. This will allow potential adjustments to the exercise type, intensity and volume during the session based on the patient’s perceived exertion. All amendments must be recorded.

Physical assessments will be performed pre-intervention, Post-exercise intervention completion (approximately 48 hrs pre-surgery), and at 30 days following surgery. Peri- and post-operative outcomes will be collected for all participants. Following the 30-day post-operative testing time-point, both groups will be invited to receive four weeks of biweekly supervised exercise training.

Missed sessions should aim to be rescheduled within the same week, if possible, while allowing at least 48 hours between exercise sessions. The total number of supervised exercise sessions should not exceed three per week. Attendance will be defined as the number of in-person exercise sessions divided by the number of planned in-person sessions. If any sessions are missed, the number and reasons should be recorded. Every attempt should be made to reschedule missed sessions.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

The usual care group will comply with normal BHS procedures. There is no current prehabilitation approach employed at Ballarat Health Services. At present, patients have an initial assessment that include outcome measures (6MWT and then depending on their current status potentially Upper Limb or Lower Limb strength tests, balance, questionnaires). Patients will then be booked in to 1-2 group sessions per week in conjunction with a HEP or just a HEP if they can’t attend supervised sessions. The primary focus is to increase cardiovascular fitness with the addition of strength based exercises to assist with improving function. This will then continue up until surgery/treatment date.

Control group

Active

Outcomes

Primary outcome [1]

To examine the effectiveness of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal and breast cancer undergoing surgery in the Grampians region of Victoria.

Assessed by number of adverse events and patient compliance. For example adverse clinical or laboratory findings, illness, or exacerbation/progression of disease/condition from the baseline assessment. All adverse events will be assessed by the prinicipal researcher present and a health professional present. An adverse event will be recorded on a AE/SAE report form and the PI responsible will present the AE to the HREC.

This is a composite outcome.

Timepoint [1]