NCT06412367

Brief 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. We hope that the results of this study will help improve care for patients having major surgery in the future.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,672

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Jun 2024Sep 2029

First Submitted

Initial submission to the registry

May 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

June 10, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3.9 years

First QC Date

May 8, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

Six Minute Walk TestFunctional assessment

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Major postoperative complications grade II to V in Clavien-Dindo scheme

    30 days after surgery

Secondary Outcomes (2)

  • Days alive and out of the hospital

    30 days after surgery

  • Significant new disability

    90 days after surgery

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Endovascular surgery
  • Lower limb orthopedic surgery
  • Contraindications to 6MWT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, L9T 6W8, Canada

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Duminda N Wijeysundera, MD PhD FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Duminda N Wijeysundera, MD PhD FRCPC

CONTACT

Janneth Pazmino-Canizares, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD FRCPC FAHA

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 14, 2024

Study Start

June 10, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations