Surgery-ComplicationsFAST WalkNCT06412367
FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK
An observational study of Surgery-Complications and Postoperative Complications, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The FAST Walk study aims to determine whether a walking test called the 6-minute walk test (6MWT) can help identify people who are more likely to experience complications after surgery. This test will be completed before surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Surgery-Complications, Postoperative Complications
- How many people
- 1,672 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2024to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: The sample will include adults who warrant preoperative risk assessment for inpatient non-cardiac surgery. To identify patients at elevated risk for complications, participants must be aged ≥40 y and have ≥1 risk factor for postoperative complications.
Who may be able to join
- Age ≥40 years
- ≥1 risk factors for postoperative complications
- Elective non-cardiac surgery with expected post-surgery stay ≥2 days
- Preoperative 6MWT is feasible
- Working knowledge of official language(s) in country of study recruitment
Who cannot join
- Endovascular surgery
- Lower limb orthopedic surgery
- Contraindications to 6MWT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, L9T 6W8
Janneth Pazmino-Canizares, MSc., 4168646060 ext. 49561, Janneth.Pazmino-Canizares@unityhealth.to
About this study
The FAST Walk study aims to determine whether a walking test called the 6-minute walk test (6MWT) can help identify people who are more likely to experience complications after surgery. This test will be completed before surgery. We hope that the results of this study will help improve care for patients having major surgery in the future.
- Conditions
- Surgery-Complications, Postoperative Complications
- Keywords
- Six Minute Walk Test, Functional assessment
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Major postoperative complications grade II to V in Clavien-Dindo scheme
Measured: 30 days after surgery
Secondary outcomes (2)
Days alive and out of the hospital
Postoperative functional recovery measured counting number of days patient is alive and not in hospital
Measured: 30 days after surgery
Significant new disability
Postoperative functional recovery measured by new disability after surgery
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start10 Jun 2024
- Primary completionMay 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,672 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Duminda Wijeysundera, Unity Health Toronto
- Investigators
- Duminda N Wijeysundera, MD PhD FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412367
- Sponsor's protocol ID
- 23-065
- Acronym
- FAST Walk
- Status last verified
- Jun 2024
- First submitted
- 8 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wijeysundera DN, Salbach NM, Chan MTV, Alibhai SMH, Puts MTE, Jerath A, Khadaroo R, Ehtesham S, Pazmino-Canizares J, Ladha KS, Granton JT, Amado L, Duceppe E, Hladkowicz E, Lee SM, Macdonell SY, Parotto M, Perlas A, Serrano PE, Thorleifson MD, van Vlymen JM, van Waes J, Racz E, Wilmhurst L, McIsaac DI; FAST Walk Study Investigators. Functional Assessment for Surgery by a Timed Walk (FAST Walk) study: protocol for a multicentre prospective cohort study of the 6 min walk test for preoperative risk stratification in major non-cardiac surgery. BMJ Open. 2026 Jan 5;16(1):e113111. doi: 10.1136/bmjopen-2025-113111.
PubMed 41490857
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK
- ClinicalTrials.gov ID
- NCT06412367
- Acronym / sponsor ID
- FAST Walk / 23-065
- Conditions
- Surgery-Complications, Postoperative Complications
- Keywords
- Six Minute Walk Test, Functional assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,672 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FAST Walk study aims to determine whether a walking test called the 6-minute walk test (6MWT) can help identify people who are more likely to experience complications after surgery. This test will be completed before surgery. We hope that the results of this study will help improve care for patients having major surgery in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The sample will include adults who warrant preoperative risk assessment for inpatient non-cardiac surgery. To identify patients at elevated risk for complications, participants must be aged ≥40 y and have ≥1 risk factor for postoperative complications.
Key inclusion criteria (5 listed)
- Age ≥40 years
- ≥1 risk factors for postoperative complications
- Elective non-cardiac surgery with expected post-surgery stay ≥2 days
- Preoperative 6MWT is feasible
- Working knowledge of official language(s) in country of study recruitment
Key exclusion criteria (3 listed)
- Endovascular surgery
- Lower limb orthopedic surgery
- Contraindications to 6MWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications
Time frame: 30 days after surgery
Major postoperative complications grade II to V in Clavien-Dindo scheme
2 secondary outcomes
Days alive and out of the hospital
Time frame: 30 days after surgery
Significant new disability
Time frame: 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 41490857Wijeysundera DN, Salbach NM, Chan MTV, Alibhai SMH, Puts MTE, Jerath A, Khadaroo R, Ehtesham S, Pazmino-Canizares J, Ladha KS, Granton JT, Amado L, Duceppe E, Hladkowicz E, Lee SM, Macdonell SY, Parotto M, Perlas A, Serrano PE, Thorleifson MD, van Vlymen JM, van Waes J, Racz E, Wilmhurst L, McIsaac DI; FAST Walk Study Investigators. Functional Assessment for Surgery by a Timed Walk (FAST Walk) study: protocol for a multicentre prospective cohort study of the 6 min walk test for preoperative risk stratification in major non-cardiac surgery. BMJ Open. 2026 Jan 5;16(1):e113111. doi: 10.1136/bmjopen-2025-113111.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duminda N Wijeysundera, MD PhD FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery-Complications and Postoperative Complications, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duminda N Wijeysundera, MD PhD FRCPC (416-864-5825, d.wijeysundera@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.