Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT03740633
Status:
UNKNOWN
Last Update Posted:
2018-11-14
First Post:
2018-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Training for the Prevention of Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 398}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-10', 'studyFirstSubmitDate': '2018-11-10', 'studyFirstSubmitQcDate': '2018-11-10', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'deep venous thrombosis', 'timeFrame': 'One years', 'description': 'incidence of deep venous thrombosis'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'One year', 'description': 'adverse events related to the functional training'}, {'measure': 'patient satisfaction', 'timeFrame': 'One year', 'description': 'patient satisfaction surveyed by customed questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Motion', 'Gynecologic Neoplasm', 'Deep Venous Thrombosis', 'Abdominal Breathing']}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having received major surgeries for gynecologic malignancies\n* Good performance status\n* Aged 18 years or older\n* Signed an approved informed consents\n* No injuries to the skin, musculoskeletal system\n* No venous thromboembolic disease before surgeries\n\nExclusion Criteria:\n\n* Not meeting all of the inclusion criteria\n* Delayed extubation'}, 'identificationModule': {'nctId': 'NCT03740633', 'briefTitle': 'Functional Training for the Prevention of Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Effects of Post-operative Functional Training on the Prevention of Deep Venous Thrombosis in the Patients of Gynecological Malignancies: A Phase 3 Randomized Control Study', 'orgStudyIdInfo': {'id': 'GO-FUN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients in the study group accept functional training and regular care.', 'interventionNames': ['Behavioral: passive ankle pump motions on the day of surgery', 'Behavioral: active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery', 'Combination Product: Regular care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients in the control group only accept regular care.', 'interventionNames': ['Combination Product: Regular care']}], 'interventions': [{'name': 'passive ankle pump motions on the day of surgery', 'type': 'BEHAVIORAL', 'description': 'Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.', 'armGroupLabels': ['Study group']}, {'name': 'active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery', 'type': 'BEHAVIORAL', 'description': 'Active ankle pump motions include flexion and extension, circumduction, which will be conducted by patient on the 1-3 day after the surgery. On the same time, the patient is given abdominal breathing training.', 'armGroupLabels': ['Study group']}, {'name': 'Regular care', 'type': 'COMBINATION_PRODUCT', 'description': 'Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Li, MD', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '008613911988831'}], 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lei Li, M.D.', 'role': 'CONTACT', 'email': 'lileigh@163.com', 'phone': '+8613911988831'}], 'overallOfficials': [{'name': 'Lei Li, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lei Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lei Li', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}