Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06412367
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1672}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2024-05-08', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'Major postoperative complications grade II to V in Clavien-Dindo scheme'}], 'secondaryOutcomes': [{'measure': 'Days alive and out of the hospital', 'timeFrame': '30 days after surgery', 'description': 'Postoperative functional recovery measured counting number of days patient is alive and not in hospital'}, {'measure': 'Significant new disability', 'timeFrame': '90 days after surgery', 'description': 'Postoperative functional recovery measured by new disability after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Six Minute Walk Test', 'Functional assessment'], 'conditions': ['Surgery-Complications', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥40 years\n2. ≥1 risk factors for postoperative complications\n3. Elective non-cardiac surgery with expected post-surgery stay ≥2 days\n4. Preoperative 6MWT is feasible\n5. Working knowledge of official language(s) in country of study recruitment\n\nExclusion Criteria:\n\n1. Endovascular surgery\n2. Lower limb orthopedic surgery\n3. Contraindications to 6MWT'}, 'identificationModule': {'nctId': 'NCT06412367', 'acronym': 'FAST Walk', 'briefTitle': 'FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'FUNCTIONAL ASSESSMENT FOR SURGERY BY A TIMED WALK', 'orgStudyIdInfo': {'id': '23-065'}}, 'contactsLocationsModule': {'locations': [{'zip': 'L9T 6W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Janneth Pazmino-Canizares, MSc.', 'role': 'CONTACT', 'email': 'Janneth.Pazmino-Canizares@unityhealth.to', 'phone': '4168646060', 'phoneExt': '49561'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Duminda N Wijeysundera, MD PhD FRCPC', 'role': 'CONTACT', 'email': 'd.wijeysundera@utoronto.ca', 'phone': '416-864-5825'}, {'name': 'Janneth Pazmino-Canizares, MSc', 'role': 'CONTACT', 'email': 'Janneth.Pazmino-Canizares@unityhealth.to', 'phone': '4168646060', 'phoneExt': '49561'}], 'overallOfficials': [{'name': 'Duminda N Wijeysundera, MD PhD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unity Health Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD FRCPC FAHA', 'investigatorFullName': 'Duminda Wijeysundera', 'investigatorAffiliation': 'Unity Health Toronto'}}}}