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NCT06412367 Clinical Trial

FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK

Postoperative Complications Clinical Trial

— FAST Walk  

Official title:
FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06412367
Other study ID # 23-065
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 10, 2024
Est. completion date September 2029

Study information
Verified date June 2024
Source Unity Health Toronto
Contact Duminda N Wijeysundera, MD PhD FRCPC
Phone 416-864-5825
Email d.wijeysundera@utoronto.ca
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Recruiting
Enrollment 1672
Est. completion date September 2029
Est. primary completion date May 2028
Accepts healthy volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Age =40 years 2. =1 risk factors for postoperative complications 3. Elective non-cardiac surgery with expected post-surgery stay =2 days 4. Preoperative 6MWT is feasible 5. Working knowledge of official language(s) in country of study recruitment Exclusion Criteria: 1. Endovascular surgery 2. Lower limb orthopedic surgery 3. Contraindications to 6MWT

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (3)
Lead Sponsor Collaborator
Unity Health Toronto Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative complications Major postoperative complications grade II to V in Clavien-Dindo scheme 30 days after surgery
Secondary Days alive and out of the hospital Postoperative functional recovery measured counting number of days patient is alive and not in hospital 30 days after surgery
Secondary Significant new disability Postoperative functional recovery measured by new disability after surgery 90 days after surgery
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