Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-01-05 @ 3:46 PM
Study NCT ID:
NCT05608759
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2022-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Prehabilitation for Patients With NSCLC Before Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise capacity', 'timeFrame': 'Baseline, 4 weeks after prehabilitation exercise', 'description': 'Exercise testing on a cycloergometer(VO2 max)'}], 'secondaryOutcomes': [{'measure': 'Forced expiratory volume in 1 s(FEV1)', 'timeFrame': 'Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery', 'description': 'Forced expiratory volume in 1 s (FEV1) of pulmonary function will be measured in liters'}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': 'Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery', 'description': 'Forced vital capacity (FVC) of pulmonary function will be measured in liters.'}, {'measure': 'Acceptance of technology', 'timeFrame': '4 weeks of prehabilitation exercise', 'description': 'number of hours the fitness tracker was worn in pre-operative period'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery', 'description': 'as assessed by the EORTC QLQ C30 questionnaire'}, {'measure': 'Change in grip-strength', 'timeFrame': 'Baseline, 4 weeks after prehabilitation exercise, 7 days after surgery, 30 days after surgery', 'description': 'Grip strength per dynamometer'}, {'measure': 'Length of stay in hospital', 'timeFrame': 'Up to 30 postoperative days', 'description': 'Number of days from surgery to discharge home'}, {'measure': 'Post-operative complications', 'timeFrame': 'From day of surgery to 30-days afterwards', 'description': 'Classified using the Clavien Dindo Classification'}, {'measure': 'Adherence to exercise', 'timeFrame': '4 weeks of prehabilitation exercise', 'description': 'number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prehabilitation', 'Cardiorespiratory fitness', 'Non-small cell lung cancer', 'Exercise', 'Wearable technology', 'Surgery'], 'conditions': ['Prehabilitation', 'Non Small Cell Lung Cancer', 'Cardiorespiratory Fitness', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '39351312', 'type': 'DERIVED', 'citation': 'Sun Q, Omindo WW, Liu W, Huang Y, Zhang R, Qian Y, Li X, Qiu R, Zheng S, Ping W, Zhang N. Your preoperative rehabilitation assistant: A study protocol for the impact of a telemedicine-supported preoperative home rehabilitation program on the prognosis of patients undergoing thoracoscopic surgery. Digit Health. 2024 Jun 5;10:20552076241258362. doi: 10.1177/20552076241258362. eCollection 2024 Jan-Dec.'}]}, 'descriptionModule': {'briefSummary': "To explore the safety and compliance of a wearable telemedicine device that can receive basic vital signs in real time, and its active supervision mode with real-time adjustment of exercise prescription for preoperative prehabilitation exercises in patients at home; and to evaluate the effectiveness of preoperative prehabilitation exercises in a telemedicine active supervision mode in patients undergoing thoracoscopic lung tumour resection, taking into account the patient's cardiopulmonary exercise test, postoperative complications and quality of life scores."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Capacity to give informed consent.\n2. Are able to tolerate surgery (i.e., segmentectomy, lobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiopulmonary exercise testing.\n3. Patients who can use a smartphone application.\n4. Patients who are diagnosed of stage I or II Non-small-cell lung carcinoma (NSCLC) diagnosis, with or without pre-operative histologic confirmation.\n5. Patients who can perform an exercise program for at least 4 weeks from the first visit to the preoperative clinic to elective surgery.\n\nExclusion Criteria:\n\n1. Known contraindication for cardiopulmonary exercise testing.\n2. Patients who have a major medical or psychiatric disorder that is expected to affect exercise.\n3. Pregnancy or lactating women.'}, 'identificationModule': {'nctId': 'NCT05608759', 'briefTitle': 'Exercise Prehabilitation for Patients With NSCLC Before Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Effect of a Home-based, Supervised Prehabilitation With Wearable Technology for Patients With Non-small Cell Lung Cancer Before Lung Resection: a Single-arm, Prospective Study', 'orgStudyIdInfo': {'id': 'TJ-IRB20220564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'single arm', 'description': '4 weeks of multimodal pre-rehabilitation', 'interventionNames': ['Behavioral: Multimodal prehabilitation']}], 'interventions': [{'name': 'Multimodal prehabilitation', 'type': 'BEHAVIORAL', 'description': '4 weeks of an supervised, pre-operative exercise prescription augmented by a wearable fitness device.', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Ping, Doctor', 'role': 'CONTACT', 'email': '247046170@qq.com', 'phone': '+8613437101581'}], 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Ni Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangnidoc@163.com', 'phone': '+8613006315393'}, {'name': 'Biyun Zhou, Doctor', 'role': 'CONTACT', 'email': 'biyun.zz@gmail.com', 'phone': '+8613517275908'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Ni', 'investigatorAffiliation': 'Tongji Hospital'}}}}