None listed
Conditions
Brief summary
This study aims to compare high intensity exercise to standard pre-operative preparation on cardiovascular fitness and incidence of post-operative complications 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. 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 and can bo done at home or in a hospital gym. 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 undergo a structured and supervised high intensity interval exercise program over three sessions per week on an individual basis for 4 weeks pre-operatively. Each participant in the treatment arm of the study will have a prescribed exercise program by a physiotherapist and will choose to do it at a hospital gym or at home with supervision via a video link with heart rate monitoring using an android tablet (supplied to the participant.
Each supervised session will comprise of at
Participants will undergo a structured and supervised high intensity interval exercise program over three sessions per week on an individual basis for 4 weeks pre-operatively. Each participant in the treatment arm of the study will have a prescribed exercise program by a physiotherapist and will choose to do it at a hospital gym or at home with supervision via a video link with heart rate monitoring using an android tablet (supplied to the participant. Each supervised session will comprise of at least 30 minutes of aerobic exercise in the form of a cycling program on an electromagnetically braked cycle ergometer, for patients exercising at home this will be supplied at no-cost and delivered. The cycling program will be prescribed at 60% of peak power achieved during a cardiopulmonary exercise test (CPET). Progression of the intensity and duration of the program’s aerobic components 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. All study participants will be asked to maintain an exercise diary for the duration of the treatment phase of the study.
Sponsors
Hunter New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years and over - Written informed consent - Operative procedure planned at least 4 weeks from randomisation date Patient must be assessed as fit for surgery by the treating Surgeon based on past medical history and CPET testing. - Patient must be undergoing a major upper gastrointestinal surgical procedure with neoadjuvant therapy including the following: * Oesophagectomy * Total/ Subtotal Gastrectomy * Pancreaticoduodenectomy * Major Liver Resection( >2 segments)
Exclusion criteria
Unresectable/ metastatic disease at any point within the study - Progressive disease during neoadjuvant chemotherapy - 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, the study cannot enrol people who don’t speak basic English as in a maximal intensity exercise program we cannot provide a safe environment without a trained, NSW Health registered translator for every exercise session. - Clinical decision by treating Surgeon that operative procedure will be scheduled less than 4 weeks
Outcome results
None listed