Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-29 @ 4:53 AM
Study NCT ID:
NCT05503004
Status:
UNKNOWN
Last Update Posted:
2023-02-21
First Post:
2022-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-14', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative physical function', 'timeFrame': 'up to 1 week', 'description': '6-minute walk test distance in meters'}, {'measure': 'Postoperative physical function', 'timeFrame': 'up to 2 weeks', 'description': '6-minute walk test distance in meters'}], 'secondaryOutcomes': [{'measure': 'ICU delirium', 'timeFrame': 'Up to 5 days', 'description': 'Assessed by nurses every shift using the Confusion Assessment Method of the Intensive Care Unit -7 (CAM-ICU-7). The CAM-ICU-7 score ranges from 0-7 with 7 being most severe.'}, {'measure': 'Health related quality of life', 'timeFrame': 'up to 4 weeks', 'description': 'Using the The EuroQol 5 Dimension 5 Level (EQ-5D-5L). The EQ-5D-5L defines health conditions based on five dimensions (e.g. mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).'}, {'measure': 'Flow State', 'timeFrame': 'up to 2 weeks', 'description': 'Using the The Flow State Scale for Occupational Tasks (FSSOT). The total score ranges from 14 to 98 points. The high score is considered to indicate the strong flow state in performing a specific task.'}, {'measure': 'Postoperative delirium', 'timeFrame': 'Up to 2 weeks', 'description': 'Assessed by nurses every shift using the 4AT Rapid clinical test for delirium. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.'}, {'measure': 'Gut microbiome diversity', 'timeFrame': 'up to 2 weeks', 'description': 'Stool collection and 16s RNA analysis'}, {'measure': 'Short chain fatty acids (SCFAs)', 'timeFrame': 'up to 2 weeks', 'description': 'Stool collection and SCFAs quantitative analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enhanced Recovery', 'Prehabilitation', 'Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '37456818', 'type': 'DERIVED', 'citation': 'Gao W, Li H, Chen Y, Zhang Y, Zhang M, Jin J. Effectiveness of a short-term multimodal prehabilitation program in adult patients awaiting selective cardiac surgery: study protocol for an open-label, pilot, randomized controlled trial. Front Cardiovasc Med. 2023 Jun 30;10:1201737. doi: 10.3389/fcvm.2023.1201737. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To determine the impact of an evidence-based comprehensive prehabilitation (EBCPrehab) program on pre- and postoperative capacity, functional capacity and health related quality of life (HRQoL) in patients awaiting elective coronary artery bypass graft surgery (CABG) or valvular surgery. Design: A single-center randomized controlled trail. SUBJECTS: Overall 160 preoperative elective cardiac surgery patients will be randomly assigned to an intervention or control group. Intervention: one-week EBCPrehab intervention, including supervised exercise, mindfulness and nutrition assessment. Control group: usual care. Main measures: At baseline, one day before surgery, three days after surgery and before discharge. The following measurements will be performed: six-minute walk test, ICU delirium, health related quality of life and flow state.', 'detailedDescription': 'Enhanced recovery improves the quality of recovery following cardiac surgery, while the evidence of prehabilitation is still limited. We hypothesize that the implementation of a comprehensive prehabilitation program, including physical, mental and nutrition support could optimize the postoperative outcomes during hospital stay.\n\nA randomized controlled study of patients undergoing cardiac surgery with prehabilitation approach, is designed to compare patient outcomes. The samples will be collected from hospital registration and the invention will be conducted before surgery. During the 5-day prehabilitation intervention, patients will receive exercises, mindfulness and nutrition risk assessment. After surgery, the 6-minute walk test, delirium assessment, flow state and health related quality of life will be assessed to explore the effects of prehabilitation on patient outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients awaiting selective coronary artery bypass graft surgery (CABG) or valvular surgery\n\nExclusion Criteria:\n\n* Disability, severe psychiatric disease.'}, 'identificationModule': {'nctId': 'NCT05503004', 'briefTitle': 'Prehabilitation in Adult Patients Following Selective Cardiac Surgery: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Second Affilliated Hospital of Zhejiang University, School of Medicine', 'orgStudyIdInfo': {'id': '20220630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'comprehensive prehabilitation program including supervised exercise., mindfulness and nutrition assessment.', 'interventionNames': ['Behavioral: Prehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Standard care before surgery', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'description': '10 min exercise, 5 min respiratory mindfulness, and preoperative nutrition assessment.', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'Standard care before surgery', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen Gao, PhD', 'role': 'CONTACT', 'email': 'wgao@zju.edu.cn', 'phone': '0571-87783887'}], 'facility': 'Second Affiliated hospital of Zhejiang university School of medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Wen Gao, PhD', 'role': 'CONTACT', 'email': 'wgao@zju.edu.cn', 'phone': '0086-18989879710'}], 'overallOfficials': [{'name': 'Wen Gao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}