None listed
Conditions
Brief summary
The study aims to compare high intensity exercise to standard pre-operative preparation to improve cardiovascular fitness in major upper gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo major upper gastrointestinal cancer surgery at John Hunter Hospital or Newcastle Private Hospital. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard pre-operative care, which consists of advice to improve fitness but no supervised or structured program. Participants in the other group will undertake prescribed, structured and supervised high intensity interval exercise over three sessions per week whilst on the wait list for major cancer surgery (approximately 30 days). This exercise will be primarily on a stationary bicycle with some walking sessions and tests for grip strength and walking distance within 6 minutes. All participants will undergo cardiovascular exercise testing upon enrolment and the week prior to surgery in order to assess any changes in fitness. A blood test will also be taken at the start and completion of the program, and a CT Scan used at the point of diagnosis and then 3 months following completion of the study. Participants will be followed for 90 days post-operatively in order to review any surgical complications, length of time in hospital, and other clinical outcomes. If the pre-operative fitness intervention is successful in this cancer population, and improved fitness relates to better outcomes, then borderline operative candidates may be able to undergo a similar program with a view to extending the option of curative surgery to a larger patient population.
Interventions
Participants will attend a hospital gym for a structured and supervised high intensity interval exercise program over three sessions per week for 4 weeks pre-operatively. Each participant will have a prescibed exercise program by a physiotherapist.
Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed at a walking speed equa
Participants will attend a hospital gym for a structured and supervised high intensity interval exercise program over three sessions per week for 4 weeks pre-operatively. Each participant will have a prescibed exercise program by a physiotherapist. Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a walking program, and a cycling program on an electromagnetically braked cycle ergometer. The walking program will be prescribed at a walking speed equal to 80% of the average speed achieved during the 6MWT. The cycling program will be prescribed at = 60% of peak power achieved during the CPET. Progression of the intensity and duration of the program’s aerobic components, both supervised and unsupervised, will be titrated to a dyspnoea score of 4-6 (Borg scale) or a rating of perceived exertion (RPE) of 14-16 depending on the symptom of exercise limitation
Sponsors
Hunter New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients undergoing major upper gastrointestinal (GI) cancer surgery at John Hunter and Newcastle Private Hospitals
Exclusion criteria
- Unresectable/ metastatic disease at any point within the study - Known Class III/IV heart failure or moderate to severe pulmonary hypertension - Poorly controlled cardiac arrhythmia/ excluded by an anaesthetist or a cardiologist - Uncontrolled hypertension >180/100 - Angina - Claudication - Vascular Aneurysm - Severe COPD with FEV1<50% predicted - For safety reasons, we cannot enrol people who don’t speak basic English in a maximal intensity exercise program as we cannot provide a safe environment without a trained, NSW Health registered translator for every exercise session.
Outcome results
None listed