None listed
Conditions
Brief summary
This study aims to generate new knowledge on the feasibility and effectiveness of pre-operative exercise training (‘prehabilitation’) to induce clinically relevant improvements in physical fitness (cardiopulmonary function) in patients with prostate, colorectal or breast cancer undergoing surgery in the Grampians region of Victoria. Who is it for? You may be eligible to join this study if you are aged 18 years or more, are scheduled for prostate, colorectal or breast cancer surgery, and are able to partake in exercise training. Study details Participants in this study will be randomly allocated (by chance) into one of two groups. Participants in one group will continue to receive usual care. Participants in the other group will undertake a supervised exercise training session once every three days (estimated four weeks) up to 3-5 days before surgery. Sessions will involve aerobic training on apparatus such as treadmill, stationary bicycle and cross-trainer for 45-60 minutes. All participants will undertake physical assessments at enrolment, post- exercise intervention completion (approximately 48 hrs pre-surgery), and at 30 days following surgery. They will also be required to complete questionnaires to measure quality of life and physical and emotional well-being. Given that the body of physical activity research in cancer prevention, management and therapy has focused almost entirely on post-operative exercise regimens, we are hoping to address this gap in the literature in regards to pre-operative exercise and provide a pathway to fixed pre-operative exercise model for future use in the Grampians region of Victoria
Interventions
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
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.
Sponsors
Federation University Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant provides written informed consent Scheduled for prostate, colorectal or breast cancer surgery Age greater than or equal to 18 years Medical clearance to undergo a symptom limited cardiopulmonary exercise test and supervised exercise training ECOG status 0-1 Participant can attend exercise training venue to meet threshold of 80% compliance with supervised exercise program. Participants must be able to understand and follow instructions in English
Exclusion criteria
Surgery scheduled in less than or equal to 2 weeks following diagnosis Any absolute or relative contraindications to participate in exercise testing as described by the American College of Sports Medicine Metastatic disease Currently enrolled in an experimental treatment with non-approved drugs at the time of enrolment Current congestive heart failure (New York Heart Association Class II, III or IV) Recent serious cardiovascular events (less than or equal to 12 months) requiring hospitalisation Uncontrolled infection, non-healing wound, bone fracture or cardiac disease that would make this protocol hazardous for the patient to participate Psychiatric illness that would prevent informed consent or study protocol adherence Any abnormality identified during the initial cardiopulmonary exercise test that indicates that it would be considered unsafe to participate in an exercise training intervention
Outcome results
None listed