Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02767895
Status:
TERMINATED
Last Update Posted:
2019-09-09
First Post:
2016-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation for PAD Revascularization Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive 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': 7}}, 'statusModule': {'whyStopped': 'Difficulty with enrollment and change in available study resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2016-05-06', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Study as Indicated by Number of Participants', 'timeFrame': '1 day', 'description': 'The feasibility of the study will be assessed by analyzing the recruitment of subjects to the study and the compliance of recruited subjects to the protocol. Feasibility will be defined as able to screening, approaching, and enrolling 25 eligible patients to the pilot study.'}, {'measure': 'Acceptability of Study as Indicated by Percentage of Participation', 'timeFrame': '8 months', 'description': 'The willingness of patients to enroll and complete the basic study procedures. Acceptability will be defined as low drop out-rates (\\<15%), completion of quality of life surveys, and \\>85% usage of the pedometers.'}], 'secondaryOutcomes': [{'measure': 'Increased Physical Activity Characteristics', 'timeFrame': '8 months', 'description': 'Increased physical activity characteristics will be assessed through the Godin Leisure Time and International Physical Activity Questionnaire, and questionnaires on barriers to and self-efficacy of exercise.'}, {'measure': 'Health-related Quality of Life', 'timeFrame': '8 months', 'description': 'Health-related quality of life and physical activity characteristics will be measured during the pre, peri, and post-operative period. This will be done through PROMIS surveys, which assess physical function, fatigue, depression, anxiety, and ability to participate in and satisfaction with social roles/activities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral Vascular Disease', 'Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.', 'detailedDescription': 'Patients undergoing elective revascularization for their peripheral artery disease 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': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented lower extremity PAD\n* Ability to walk at least 1 block\n* Sedentary\n* Medical clearance from the surgical team\n* Competent to provide consent\n\nExclusion Criteria:\n\n* Life expectancy \\< 6 months\n* Co-morbidities which limit walking to a severe degree\n* Signs of critical limb ischemia\n* Recent or current enrollment in a formal exercise program\n* Recent cardiovascular events including stroke, TIA, severe valve disease, etc.\n* Current substance abuse\n* Psychiatric disorder which limits ability to participate in study procedures\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT02767895', 'briefTitle': 'Prehabilitation for PAD Revascularization Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'A Pilot Trial of Prehabilitation Among Patients Undergoing PAD Revascularization', 'orgStudyIdInfo': {'id': 'HUM00113096'}}, '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': 'Elizabeth Jackson, MD, MPH', '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 Internal Medicine', 'investigatorFullName': 'Elizabeth A. Jackson', 'investigatorAffiliation': 'University of Michigan'}}}}