Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-01-05 @ 2:54 AM
Study NCT ID:
NCT04934657
Status:
UNKNOWN
Last Update Posted:
2022-01-26
First Post:
2021-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Perioperative Daily Steps and Postoperative Recovery Among Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 487}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the length of hospital stay', 'timeFrame': 'within 7 days after operation or before discharge, whichever came first', 'description': 'postoperative length of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['daily step, recovery, length of hospital stay'], 'conditions': ['Postoperative Recovery']}, 'referencesModule': {'references': [{'pmid': '40800130', 'type': 'DERIVED', 'citation': 'Yao Y, Wang Y, Liu Y, Yu Y, Wang X, Wang T, Zheng B, Yan M. Association of perioperative step count tracked by a wristband with surgical outcomes in minimally invasive lung cancer surgery: a prospective observational study. Front Med (Lausanne). 2025 Jul 29;12:1590327. doi: 10.3389/fmed.2025.1590327. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Walking is the most common, simple and convenient way of exercise with the lowest cost. Studies have shown that daily steps are related to important health outcomes such as cardiovascular events and all-cause mortality. Catrine et al. believe that daily steps can be used as a basic index to evaluate physical fitness. Many observational studies have found that postoperative daily steps collected by wearable devices or smart phones are related to length of hospital stay or even postoperative depression, which is suggested that the average daily steps may be an important index to predict the prognosis of patients.\n\nSo the investigators aim to explore the association between peri-operative average daily steps and postoperative recovery of patients scheduled for elective surgery.', 'detailedDescription': 'Patients scheduled to undergoing elective surgery including thoracic surgery ,abdominal surgery, primary hip replacement and radical mastectomy will be recruited.The exclusion criteria are as follows: With preoperative unconsciousness; Day surgery (planned length of stay \\< 1 day); Wheelchair, walking aid or crutch were used before operation; Unable to walk due to physical limitations; The collection time of preoperative steps was less than 1 week; The patient refused to participate.\n\nAfter recruitment and screening , the investigators will ask the participants to wear a smart band to record data of their daily steps , in addition the investigators will collect the peri-operative data of these participants which includes their rehabilitations and clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the participants are adult patients scheduled to undergo elective surgery including thoracic surgery ,abdominal surgery, primary hip replacement and radical mastectomy.They will be asked to wear smart band to record their daily steps when they do the preoperative evaluation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients scheduled to undergo elective surgery including thoracic surgery abdominal surgery, primary hip replacement and radical mastectomy ; Age≥18 ASA Ⅰ～Ⅲ Able to wear smart band\n\nExclusion Criteria:\n\nWith preoperative unconsciousness Day surgery (planned LOS \\< 1 day) Wheelchair, walking aid or crutch were used before operation Unable to walk due to physical limitations The collection time of preoperative steps was less than 1 week The patient refused to participate'}, 'identificationModule': {'nctId': 'NCT04934657', 'briefTitle': 'Association of Perioperative Daily Steps and Postoperative Recovery Among Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Second Affiliated Hospital of Zhejiang University, School of Medicine', 'orgStudyIdInfo': {'id': '2021-0344'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal steps', 'description': 'patients in this group have normal preoperative step counts', 'interventionNames': ['Other: no intervention']}, {'label': 'low steps', 'description': 'patients in this group have low preoperative step counts', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['low steps', 'normal steps']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University anesthesiology department', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Yan, MD', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '13757118632'}], 'overallOfficials': [{'name': 'Min Yan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}