Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001094167
Ethics application status
Approved
Date submitted
11/07/2019
Date registered
9/08/2019
Date last updated
1/09/2022
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Pre-operative High Intensity Interval Exercise Improve Surgical Outcomes After Major Abdominal Surgery?
Scientific title
Multicentre Pre-operative Prehabilitation to Reduce Surgical Complications in Patients undergoing Major Upper GI Resections.
Secondary ID [1] 298716 0
JHGIS014
Universal Trial Number (UTN)
Trial acronym
MuPPET Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical complications following major upper gastrointestinal surgery. 313624 0
Oespohageal Cancer 313625 0
Condition category
Condition code
Surgery 312055 312055 0 0
Other surgery
Cancer 312057 312057 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314975 0
Treatment: Other
Intervention code [2] 315194 0
Prevention
Comparator / control treatment
Current standard of care. Patients are adivsed by the treating surgeon to exercise and improve their fitness but are not provided with a supervised/ structured program.
Control group
Active

Outcomes
Primary outcome [1] 320687 0
Proportion of participants suffering major postoperative complication as defined by Clavien-Dindo Classification III or greater - complication requiring surgical, endoscopic or radiological intervention, or resulting in unexpected transfer to an intensive care unit with single or multi-organ failure, or death. Data will be collected from hospital records.
Timepoint [1] 320687 0
Day 30 post-operatively
Secondary outcome [1] 372488 0
Proportion of participants achieving an increase of at least 1.5mL/kg/min as determined by serial cardiopulmonary exercise testing using a metabolic cart test conducted on a cycle ergometer prior to randomisation and done prior to the operative procedure.
Timepoint [1] 372488 0
Time point of initial CPET is following the first clinic visit to book surgery and the final CPET is in the week prior to surgery.
Secondary outcome [2] 372489 0
Mortality incidence
Timepoint [2] 372489 0
90 days post-operatively
Secondary outcome [3] 372490 0
Proportion of patients who undergo the planned operative intervention (resection rate) assessed by review of the operative report.
Timepoint [3] 372490 0
Day 30 post-operatively
Secondary outcome [4] 372491 0
Completion of intended oncological (neo-adjuvant chemotherapy and radiation) as assessed by review of medical and radiation oncology correspondence.
Timepoint [4] 372491 0
Assessed within 7 days of prior to surgery.
Secondary outcome [5] 372492 0
Pos-toperative pulmonary complication as defined by the Melbourne Group Scale
Timepoint [5] 372492 0
Day 90 post-operatively
Secondary outcome [6] 372493 0
Days spent in ICU (mean) as determined by review of ICU admit and discharge dates from the medical record.
Timepoint [6] 372493 0
Day 90 post-operatively
Secondary outcome [7] 372494 0
Hospital length of stay as determined by review of hospital admit and discharge dates from the medical record.
Timepoint [7] 372494 0
Assessed at point of discharge
Secondary outcome [8] 372495 0
Sarcopaenia as determined by CT Scan at time of diagnosis and 3 months following surgery
Timepoint [8] 372495 0
Initial scan around the time of initial clinic visit and subsequent CT scan 3 months following surgery
Secondary outcome [9] 372496 0
Change in serum C1q level (mean).
Timepoint [9] 372496 0
Initial test following clinic visit where surgery is booked, final test in the week prior to surgery
Secondary outcome [10] 372497 0
SF-36 Version 2 Physical activity questionnaire
Timepoint [10] 372497 0
Pre-treatment (prior to undertaking the randomised arm)and within 7 days of surgery.
Secondary outcome [11] 372498 0
CONUT Nutritional Questionnaire
Timepoint [11] 372498 0
Day of Surgery

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation computer.
Treating surgeons and outcome assessor blinded to treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Simple stratification according to procedure type has already been performed (I.e. oesophagectomy vs other Upper GI/ HPB resections)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Porject abandoned, recrutiment never opened.
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14213 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 27196 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 303268 0
Hospital
Name [1] 303268 0
John Hunter Hospital Charitable Trust
Country [1] 303268 0
Australia
Funding source category [2] 303269 0
Other
Name [2] 303269 0
Philanthropic Donation
Country [2] 303269 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 303278 0
None
Name [1] 303278 0
Address [1] 303278 0
Country [1] 303278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303807 0
Hunter New England Human Research Ethics Comittee
Ethics committee address [1] 303807 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 303807 0
Australia
Date submitted for ethics approval [1] 303807 0
30/04/2019
Approval date [1] 303807 0
16/08/2019
Ethics approval number [1] 303807 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94878 0
Dr David Burnett
Address 94878 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 94878 0
Australia
Phone 94878 0
+61249236397
Fax 94878 0
Email 94878 0
[email protected]
Contact person for public queries
Name 94879 0
Dr David Burnett
Address 94879 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 94879 0
Australia
Phone 94879 0
+61240236397
Fax 94879 0
Email 94879 0
[email protected]
Contact person for scientific queries
Name 94880 0
Dr David Burnett
Address 94880 0
Surgical Services
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 94880 0
Australia
Phone 94880 0
+61249236397
Fax 94880 0
Email 94880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Still to be determined.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.