Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06260293
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shorts Physical Performance Battery(SPPB)', 'timeFrame': '"1 day before surgery", "POD3", "POD 1month"', 'description': 'SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity. instrument of balance, lower extremity strength, and functional capacity. The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult men and women 19 years of age or older\n2. Pathologically diagnosed gastric cancer\n3. Able to undergo radical resection (R0)\n4. Scheduled for minimally invasive surgery (MIS)\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Have received chemotherapy and radiation before surgery\n3. Scheduled for open surgery\n4. Subjects who do not understand or have not given informed consent\n5. If healthcare provider (primary care physician) deems it difficult for you to exercise'}, 'identificationModule': {'nctId': 'NCT06260293', 'briefTitle': 'The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study', 'orgStudyIdInfo': {'id': '4-2022-0208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'interventionNames': ['Behavioral: exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care group'}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'A total of 4 exercise interventions.\n\nTwice In-patient exercise interventions: exercises on the ward at POD1, and POD2, and Recommended walking and stretching.\n\nTwice home-based exercise interventions: post-discharge, Recommended 30 minutes of low to moderate-intensity walking and daily bodyweight exercises per day(150 minutes each week). and remote exercises 1 per week.', 'armGroupLabels': ['Exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Surgery, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyoung-Il Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Yonsei University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}