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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.
Scientific title
"The FAST WALK Study - impact of a Functional Assessment for Surgery by a Timed WALK on postoperative complications".
Secondary ID [1] 314658 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FAST WALK STUDY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective non-cardiac surgery 337832 0
Postoperative complications 337833 0
Condition category
Condition code
Surgery 334165 334165 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 331285 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Active

Outcomes
Primary outcome [1] 341816 0
Postoperative complications
Timepoint [1] 341816 0
within 30 days of surgery
Secondary outcome [1] 448773 0
Death or significant new disability
Timepoint [1] 448773 0
at 90 days after surgery
Secondary outcome [2] 448774 0
days alive and out of hospital
Timepoint [2] 448774 0
at 30 days after surgery

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Endovascular surgery
2. Lower limb orthopedic surgery
3. Contraindications to 6MWT

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment outside Australia
Country [1] 27124 0
Canada
State/province [1] 27124 0

Funding & Sponsors
Funding source category [1] 319222 0
Other
Name [1] 319222 0
Canadian Insutute of Health Services
Country [1] 319222 0
Canada
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321690 0
None
Name [1] 321690 0
Address [1] 321690 0
Country [1] 321690 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317800 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 317800 0
Ethics committee country [1] 317800 0
Australia
Date submitted for ethics approval [1] 317800 0
02/01/2025
Approval date [1] 317800 0
27/02/2025
Ethics approval number [1] 317800 0
HREC/115213/PMCC

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

Contacts
Principal investigator
Name 142198 0
Dr Julia Dubowitz
Address 142198 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 142198 0
Australia
Phone 142198 0
+61 3 8559 7713
Fax 142198 0
Email 142198 0
Contact person for public queries
Name 142199 0
Julia Dubowitz
Address 142199 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 142199 0
Australia
Phone 142199 0
+61 3 8559 5000
Fax 142199 0
Email 142199 0
Contact person for scientific queries
Name 142200 0
Julia Dubowitz
Address 142200 0
Peter MacCallum Cancer Centre, 305 Grattan St, Parkville, VIC, 3000
Country 142200 0
Australia
Phone 142200 0
+61 3 8559 5000
Fax 142200 0
Email 142200 0

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.