FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK (FAST Walk)

May 8, 2024 updated by: Duminda Wijeysundera, Unity Health Toronto
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1672

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days after surgery
Major postoperative complications grade II to V in Clavien-Dindo scheme
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days alive and out of the hospital
Time Frame: 30 days after surgery
Postoperative functional recovery measured counting number of days patient is alive and not in hospital
30 days after surgery
Significant new disability
Time Frame: 90 days after surgery
Postoperative functional recovery measured by new disability after surgery
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation

Investigators

  • Principal Investigator: Duminda N Wijeysundera, MD PhD FRCPC, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe