Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06370702
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-12
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deep vein thrombosis', 'timeFrame': 'from PICC placement to PICC removal, up to 4 weeks', 'description': 'Incidence of deep vein thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Had a PICC placed in the past 24 hours by the Vascular Access Team\n* Patient is admitted to either Bethesda North Hospital or Good Samarian Hospital\n\nExclusion Criteria:\n\n* Under 18 years old\n* Does not speak English\n* Unable to consent to involvement in the research study\n* Has a bleeding disorder/diagnosis\n* Has a severe limb disfunction whereby they would be unable to perform the grip exercises'}, 'identificationModule': {'nctId': 'NCT06370702', 'briefTitle': 'Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines', 'orgStudyIdInfo': {'id': '23-054'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Handgrip Exercise Group', 'description': 'Participants will be instructed to firmly grip and squeeze the ball for 10 seconds, relax for 10 seconds and repeat for 10 minutes. They will be instructed to do this 3 times per day.', 'interventionNames': ['Other: Handgrip Exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Group', 'description': 'Participants will receive standard care that includes no instruction about conducting hand grip exercises.'}], 'interventions': [{'name': 'Handgrip Exercises', 'type': 'OTHER', 'description': 'Participants will firmly grip and squeeze the ball for 10 seconds, relax for 10 seconds and repeat for 10 minutes. They will be instructed to do this 3 times per day.', 'armGroupLabels': ['Handgrip Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Bethesda North Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Rachel Baker, PhD, RN', 'role': 'STUDY_CHAIR', 'affiliation': 'TriHealth Nurse Researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}