Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-05 @ 12:22 PM
Study NCT ID:
NCT02767518
Status:
TERMINATED
Last Update Posted:
2022-01-24
First Post:
2016-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation for Aortic Repair Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}], 'ancestors': [{'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082622', 'term': 'Preoperative Exercise'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Transfer of main study team to another institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-06', 'studyFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2016-05-06', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of recruiting and enrolling', 'timeFrame': '1 year', 'description': 'We will measure feasibility according to whether we are able to recruit and enroll subjects.'}], 'secondaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '1 year', 'description': 'We will ask patients to describe their experiences with the prehab program.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Aneurysm']}, 'descriptionModule': {'briefSummary': 'This is a 2-group study comparing the effect of a "prehabilitation" program to usual care on quality of life and clinical outcomes in patients undergoing elective repair of their thoracic aorta.', 'detailedDescription': 'Patients undergoing elective repair of their thoracic aortic aneurysm will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 years or older\n* Diagnosis of thoracic aortic disease with scheduled repair\n* Medical clearance from cardiothoracic surgeon\n* Ability to provide informed consent\n* Regular use of a smartphone or personal computer\n\nExclusion Criteria:\n\n* Conditions that limit walking to a severe degree\n* Current participation in regular physical activity program\n* Acute aortic dissection\n* Recent coronary artery disease events\n* Inability to speak and read English'}, 'identificationModule': {'nctId': 'NCT02767518', 'acronym': 'PREPARE', 'briefTitle': 'Prehabilitation for Aortic Repair Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Does Prehabilitation Prior to Thoracic Aortic Repair Improve Quality of Care?', 'orgStudyIdInfo': {'id': 'HUM00109521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation', 'description': 'Participants will be referred to the Michigan Surgical \\& Health Optimization Program in the month leading up to their surgery. Individuals are encouraged to increase their physical activity, practice stress reduction, and other behaviors associated with good health.', 'interventionNames': ['Behavioral: Prehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants will follow the pre-operative instructions provided by their surgical team.'}], 'interventions': [{'name': 'Prehabilitation', 'type': 'BEHAVIORAL', 'otherNames': ['MSHOP - Michigan Surgical & Health Optimization Program'], 'description': 'Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.', 'armGroupLabels': ['Prehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Bo Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Dr. Bo Yang', 'investigatorAffiliation': 'University of Michigan'}}}}