Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000872437
Ethics application status
Approved
Date submitted
20/05/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising surgical outcomes: evaluating the efficacy of a co-designed prehabilitation program at West Moreton Health - Phase 3
Scientific title
Optimising surgical outcomes: evaluating the efficacy of a co-designed prehabilitation program at West Moreton Health - Phase 3
Secondary ID [1] 314486 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective Abdominal Surgery 337526 0
Condition category
Condition code
Surgery 333893 333893 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 3 (Intervention - Yet to Begin Recruitment):
PLEASE NOTE - this is not an RCT (with the main outcome of this study being feasibility of implementation). There is no allocation beyond recruitment. Participants in this Part/Phase 3 will be allocated to all intervention arms allowed for by time and consent.
Participants will be allocated to receive 1, 2, 3 or all 4 arms of the intervention depending upon when they choose to enrol in the study relative to their scheduled surgery. Participants who choose to enrol 4 or more weeks prior to their surgery will receive all 4 arms, participants who choose to enrol 2-3 weeks prior to their surgery will receive arms 1-3.

PREHABILITATION
Arm 1: Physiotherapy Led Education - Priority 1 (If recruited <1 week from surgery)
- 30 Minutes Face to Face Education with a Physiotherapist regarding Respiratory Function, Mucociliary Clearance, and self directed breathing exercises to complete post operatively (2 sets of 10 deep breaths with 5 second inspiratory hold, with 3x coughs or huffs with supported bracing, every hour while awake).. Created handout/brochure educational materials also provided (currently pending approval) to provide alongside.
- Delivered <1/52 from scheduled surgery

Arm 2: Dietitian Led Education - Priority 2 (Delivered <2/52 from scheduled surgery)
- Face to Face OR Telehealth 30 minute dietitian consult conducted within existing dietitian outpatient clinical service. Dietitian will conduct a Subjective Global Assessment to determine nutritional status.
Participants identified as malnourished or at risk of malnutrition will be provided high protein, high energy education and patient resources from NEMO (nutrition education material online). These nutrition education materials are designed for members of the public and provide nutritional information targeted at Grade 7 English levels. Participants who are malnourished may also be prescribed high protein, high energy drinks if clinically appropriately.
Depending on the surgery, participants may be upgraded on diet progression post-surgery e.g. Clear fluid diet, free fluid diet and low fibre diet. These resources are available on NEMO. This will be based on participant situation.
For participants who are well nourished at baseline and not identified as nutritional risk they will be provided this material. They will also be directed to watch the Nutrition before surgery video developed by Queensland health dietitian.

Video - Nutrition Before Surgery (https://vimeo.com/709278790)


Arm 3: Inspiratory Muscle Training (IMT) - Priority 3 (if recruited 2-3/52 prior to Scheduled Surgery)
- 30 Minute Face to face physiotherapy led motivational interview, education, free provision of IMT device (POWERBreathe Medic Plus) and individualised prescription (targeting 50% of Max Inspiratory Pressure, 2x30 reps daily until surgery), and progressive walking program prescription (intensity recommendations inline with Australian Governments Physical Activity and exercise guidelines for all Australians - participants self assessing exercise intensity with education - goal of 30 minutes moderate intensity exercise daily until surgery).

Arm 4: Group Cardiovascular Exercise - Priority 4 (if recruited 4/52 prior to scheduled surgery)
- Face to Face, biweekly, 1 hour long, supervised individualised group exercise classes provided by university student led exercise physiology clinic, for 4 weeks prior to surgery
- intensity and specific exercises as prescribed by student exercise physiologists under Accredited Exercise Physiologist supervision, with referral and exercise clearance being provided by Trial Medical Officer. Participants will not be specifically directed to complete additional exercises at home as a part of the intervention.

adherence to all arms will be monitored by session attendance and participant feedback using an 'Adherance Log' form each participant will complete.
participant input and feedback will be sought through semi structured interviews reflecting on their hospital recovery following their surgery, comparing with historical control data prior to intervention. This will inform the basis of codesign for full implementation / feasibility of a future model (noting that a large component of historical data collection for codesign was investigating participants desire for PT/dietitian input as well as face to face vs telehealth data).
Intervention code [1] 331109 0
Prevention
Comparator / control treatment
Control: Historical Group Data collected during phase 1 and 2 (observational study to be registered separately), which was completed prior to the commencement of this interventional trial (Phase 3) will serve as the historical control group.

Data collection around post abdominal surgery outcomes in cohort (nil change to practice), specifically looking at:
o Hospital length of stay
o Discharge destination (planned destination vs actual destination)
o Unplanned return to operating theatre
o Unplanned intensive care admission
o Unplanned hospital readmission within 30 days
o Post-operative pulmonary complication rate using the ‘Melbourne Group Score’ diagnostic criteria
o Duke Activity Status Index (DASI)
o Quality of Recovery Measure – QOR-15

Observation over ~6 month period, resulting in ~22 participants.
Control group
Historical

Outcomes
Primary outcome [1] 341534 0
Post Operative Pulmonary Complications (PPC)
Timepoint [1] 341534 0
Data collected during usual care admission, post hospital discharge chart audit to ascertain diagnosis of PPC
Primary outcome [2] 341535 0
Hospital Length Of Stay
Timepoint [2] 341535 0
Post Discharge
Primary outcome [3] 341536 0
Quality of Recovery
Timepoint [3] 341536 0
D0 Pre-operation, D1 Post Operation and ~ 2 Weeks Post Operation
Secondary outcome [1] 447861 0
Unplanned Return to Operating Thearter
Timepoint [1] 447861 0
Post Discharge
Secondary outcome [2] 447862 0
Unplanned Intensive Care Unit Admission
Timepoint [2] 447862 0
post discharge
Secondary outcome [3] 447863 0
Unplanned hospital readmission within 30 days
Timepoint [3] 447863 0
30 days post Discharge
Secondary outcome [4] 447865 0
Discharge Destination (planned destination vs actual destination)
Timepoint [4] 447865 0
Post Discharge

Eligibility
Key inclusion criteria
Patients Attending Anaesthetic Outpatient Clinic at Ipswich Hospital, in preparation for abdominal surgery AND (aged greater than 60 years old OR First Nations person aged greater than 40 years old) AND identified as benefitting from prehabilitation by the treating clinician.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to consent to study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants enrolled during Phase/Part 3 of the study are all allocated to receive the intervention. Their outcomes will be compared with historical data collected in Phase/Part 1+2 (observational study to be registered separately) prior to commencement of this interventional trial (Phase/Part 3).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/08/2025
Actual
Date of last participant enrolment
Anticipated
30/10/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27963 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 44155 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 319028 0
Government body
Name [1] 319028 0
West Moreton Health Research Grant Program
Country [1] 319028 0
Australia
Primary sponsor type
Individual
Name
Dr Mitchell Kelly - Ipswich Hospital
Address
Country
Australia
Secondary sponsor category [1] 321492 0
Individual
Name [1] 321492 0
Dr Abigail Marsh - Ipswich Hospital
Address [1] 321492 0
Country [1] 321492 0
Australia
Secondary sponsor category [2] 321493 0
Individual
Name [2] 321493 0
Jacob Skerman - Ipswich Hospital
Address [2] 321493 0
Country [2] 321493 0
Australia
Other collaborator category [1] 283525 0
Individual
Name [1] 283525 0
Dr Marc Nickels - Ipswich Hospital
Address [1] 283525 0
Country [1] 283525 0
Australia
Other collaborator category [2] 283526 0
Individual
Name [2] 283526 0
Sally Elsom - Ipswich Hospital
Address [2] 283526 0
Country [2] 283526 0
Australia
Other collaborator category [3] 283527 0
Individual
Name [3] 283527 0
Dr Bipphy Kath - Ipswich Hospital
Address [3] 283527 0
Country [3] 283527 0
Australia
Other collaborator category [4] 283528 0
Individual
Name [4] 283528 0
Dr Stephanie Law - Ipswich Hospital
Address [4] 283528 0
Country [4] 283528 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317636 0
West Moreton Hospital and Health Service
Ethics committee address [1] 317636 0
Ethics committee country [1] 317636 0
Australia
Date submitted for ethics approval [1] 317636 0
22/04/2025
Approval date [1] 317636 0
11/07/2025
Ethics approval number [1] 317636 0
HREC/2024/QWMS/111504

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141646 0
Dr Mitchell Kelly
Address 141646 0
Ipswich Hospital, Chelmsford Avenue, Ipswich, QLD, 4305
Country 141646 0
Australia
Phone 141646 0
+61 07 3810 1166
Fax 141646 0
Email 141646 0
[email protected]
Contact person for public queries
Name 141647 0
Mitchell Kelly
Address 141647 0
Ipswich Hospital, Chelmsford Avenue, Ipswich, QLD, 4305
Country 141647 0
Australia
Phone 141647 0
+61 07 3810 1166
Fax 141647 0
Email 141647 0
[email protected]
Contact person for scientific queries
Name 141648 0
Mitchell Kelly
Address 141648 0
Ipswich Hospital, Chelmsford Avenue, Ipswich, QLD, 4305
Country 141648 0
Australia
Phone 141648 0
+61 07 3810 1166
Fax 141648 0
Email 141648 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: West Moreton Health Ethics Committee:
Email: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.