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Trial registered on ANZCTR
Registration number
ACTRN12625000747426
Ethics application status
Approved
Date submitted
17/06/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The FAST WALK Study - Functional assessment for surgery by a timed walk.
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Scientific title
"The FAST WALK Study - impact of a Functional Assessment for Surgery by a Timed WALK on postoperative complications".
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Secondary ID [1]
314658
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
FAST WALK STUDY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Elective non-cardiac surgery
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Postoperative complications
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Condition category
Condition code
Surgery
334165
334165
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
All interventions will administered by a trained member of the research team.
1. All participants will undergo a preoperative six-minute walk test and grip strength test face to face, and will take around 30 minutes to complete.
2. Baseline blood tests and an ECG will be performed.
3. Baseline questionnaires will be administered - MET-REPAIR, EQ-5D (5-level version), Patient-Reported Outcomes Measurement Information System (PROMIS) – 29 General Health Profile, Brief Resilience Scale (BRS), PROMIS Social Isolation Short Form 4a
3. Postoperative blood tests (and ECG is troponin is elevated) will be performed on days 1, 2 and 3, as long as the patient remains an inpatient.
Data fidelity will be ensured by data autinign and oversight by a trial data steering committee.
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Intervention code [1]
331285
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Diagnosis / Prognosis
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Comparator / control treatment
no control group
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Control group
Active
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Outcomes
Primary outcome [1]
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Postoperative complications
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Assessment method [1]
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(Grade II to V in Clavien-Dindo scheme)
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Timepoint [1]
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within 30 days of surgery
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Secondary outcome [1]
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Death or significant new disability
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Assessment method [1]
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Grade II to V in Clavien-Dindo scheme
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Timepoint [1]
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at 90 days after surgery
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Secondary outcome [2]
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days alive and out of hospital
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Assessment method [2]
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medical records
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Timepoint [2]
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at 30 days after surgery
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Eligibility
Key inclusion criteria
1. Age greater than or equal to 40 years
2. greater than or equal to 1 risk factors for postoperative complications
3. Elective non-cardiac surgery with expected post-surgery stay greater than or equal to 2 days
4. Preoperative 6MWT is feasible
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Endovascular surgery
2. Lower limb orthopedic surgery
3. Contraindications to 6MWT
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
1672
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment outside Australia
Country [1]
27124
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Canada
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State/province [1]
27124
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Funding & Sponsors
Funding source category [1]
319222
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Other
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Name [1]
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Canadian Insutute of Health Services
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Address [1]
319222
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Country [1]
319222
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Canada
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321690
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Address [1]
321690
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Country [1]
321690
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317800
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Peter MacCallum Cancer Centre Human Research Ethics Committee
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Ethics committee address [1]
317800
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https://www.petermac.org/research/doing-research-us/ethics-governance
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Ethics committee country [1]
317800
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Australia
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Date submitted for ethics approval [1]
317800
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02/01/2025
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Approval date [1]
317800
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27/02/2025
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Ethics approval number [1]
317800
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HREC/115213/PMCC
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Summary
Brief summary
The FAST Walk study is a multicentre prospective cohort study that aims to enrol 1672 participants in Canada and Australia. The FAST Walk study will evaluate the association of 6MWT distance and 3 tests completed before surgery with outcomes assessed at 30 days and 90 days after major non-cardiac surgery. The primary aim of the study is to determine whether preoperative 6MWT distance adds prognostic value to usual clinical factors for predicting 30-day major postoperative complications. We hypothesise that a 6MWT will improve prediction of complications are elective non-cardiac surgery.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Julia Dubowitz
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Address
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Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
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Country
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Australia
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Phone
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+61 3 8559 7713
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Julia Dubowitz
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Address
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Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
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Country
142199
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Australia
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Phone
142199
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+61 3 8559 5000
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Fax
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Email
142199
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[email protected]
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Contact person for scientific queries
Name
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Julia Dubowitz
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Address
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Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
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Country
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Australia
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Phone
142200
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+61 3 8559 5000
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Fax
142200
0
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Email
142200
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[email protected]
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Data sharing statement
Will the study consider sharing 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.
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