Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 10:11 AM
Study NCT ID:
NCT02911493
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Sedentary Time in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects that are more active than Control.', 'timeFrame': 'Monthly for 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sedentary time', 'number of steps/day', 'mobility', 'disability'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NYHA II-IV,\n* Age ≥ 65,\n* SPPB score of \\> 4 and ≤ 10 of 12,\n\n * and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and\n * blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.\n\nExclusion Criteria:\n\n* Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)\n* Oxygen dependent lung disease,\n* Orthopedic or neurologic disease that severely limits mobility,\n* Active cancer diagnosis except non-melanoma skin cancer,\n* Geriatric Depression Scale (GDS) score of ≥ 9 ,\n* Limited life-expectancy of \\<6 months,\n* Known dementia or disease that effects ability to learn/follow directions, or\n* Failed MiniCog test.'}, 'identificationModule': {'nctId': 'NCT02911493', 'acronym': 'Rest-HF', 'briefTitle': 'Reducing Sedentary Time in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Reducing Sedentary Time in Patients With Heart Failure', 'orgStudyIdInfo': {'id': '16-1330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedentary Group-Experimental', 'description': 'The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.', 'interventionNames': ['Behavioral: Reducing Sedentary Behavior']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical Activity Group', 'description': 'The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.', 'interventionNames': ['Behavioral: Physical Activity Group']}], 'interventions': [{'name': 'Reducing Sedentary Behavior', 'type': 'BEHAVIORAL', 'description': 'The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.', 'armGroupLabels': ['Sedentary Group-Experimental']}, {'name': 'Physical Activity Group', 'type': 'BEHAVIORAL', 'description': 'The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.', 'armGroupLabels': ['Physical Activity Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado University', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Rebecca Boxer, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}