Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT06458894
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the first ambulation after surgery', 'timeFrame': '3 Weeks after intervention', 'description': 'Patients can complete the time of walking at the bed, and unplanned extubation'}, {'measure': 'Dwelling time of chest drain and chest drainage flow', 'timeFrame': 'Two days after the intervention', 'description': 'The duration of the postoperative chest drain and the chest on postoperative day 1 and postoperative day 2 were recorded Lead the flow'}], 'secondaryOutcomes': [{'measure': 'Lung function index', 'timeFrame': '30 Days after intervention', 'description': 'Pulmonary function test was performed with the pulmonary function detector on the day of the patient and 30 days after surgery Guide the patient to do inhale or exhale with maximum effort, make three consecutive measurements, and record the best results, including Forced expiratory volume at second 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study, based on the Internet platform, involving family caregivers in preoperative management, not only promotes patient compliance with preoperative rehabilitation exercise, but also provides multi-way rehabilitation measures for elderly patients with limited mobility or medical difficulties, and also provides new ideas for other specialties。', 'detailedDescription': 'This study using a randomized controlled trial, 100 patients that meet the inclusion criteria are divided into experimental group and control group, experimental group adopts routine nursing measures, intervention group for preoperative family rehabilitation training, intervention for 2 weeks, observe the first after surgery, lung function index, chest catheterization days, postoperative hospital stay and medical expenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age ≥ 60 years old; 2. A preliminary diagnosis of pulmonary结节 or lung tumor by chest CT; 3. Planning to undergo thoracoscopic lung resection surgery; 4. Voluntary participation of patients.\n\nExclusion Criteria:\n\n1\\. Patients with severe condition who cannot tolerate pre-rehabilitation training; 2. Patients with consciousness disorder or mental abnormalities who cannot cooperate with pre-rehabilitation training; 3. Patients who cannot complete questionnaire filling out due to visual, auditory, or intellectual impairment, etc.'}, 'identificationModule': {'nctId': 'NCT06458894', 'briefTitle': 'Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': 'Research on Building and Application of Internet-based Home Pre-rehabilitation Model for Lung Surgery Patients.', 'orgStudyIdInfo': {'id': 'KY-2024-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'There were no interventions', 'description': 'Give guidance on respiratory function exercise', 'interventionNames': ['Behavioral: Prerehabilitation']}, {'type': 'OTHER', 'label': 'Prerehabilitation', 'description': 'Give guidance on respiratory function exercise', 'interventionNames': ['Behavioral: Prerehabilitation']}], 'interventions': [{'name': 'Prerehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['ulmonary function'], 'description': 'Home prerehabilitation was performed on the basis of routine preoperative preparation', 'armGroupLabels': ['Prerehabilitation', 'There were no interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '322000', 'city': 'Yiwu', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'chaoqian li', 'role': 'CONTACT'}], 'facility': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'chaoqian li', 'role': 'CONTACT', 'email': '13858066862@163.com', 'phone': '13858066862'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}