Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-03-25 @ 4:24 AM
Study NCT ID:
NCT00643695
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of symptoms of depression as measured by the Beck Depression Inventory II (BDI-II)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in symptoms of fatigue as measured by the Brief Fatigue Inventory (BFI)', 'timeFrame': '12 weeks'}, {'measure': 'reduce the reported level of chronic pain', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatitis C', 'depression', 'exercise'], 'conditions': ['Hepatitis C', 'Depression']}, 'descriptionModule': {'briefSummary': "In this study, depressed veterans with hepatitis C will be randomly assigned to the control group or to the exercise intervention group. The exercise intervention is designed to begin slowly for most participants and to progress within each participant's target heart rate range for moderate intensity exercise. The exercise intervention is a 12 week home based walking program. Ideally individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.\n\nCentral Hypothesis Veterans who receive the exercise intervention will be significantly less symptomatic for depression than veterans in the control group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age 18 or older\n* Documentation of positive hepatitis C status as indicated by a detectable HCV viral load by polymerase chain reaction\n* Mild to moderate depressive symptoms as evidenced by a BDI II score of ≥ 14\n* Able to read and understand English\n* Written/signed informed consent specific to this protocol\n* Being sedentary that is , less than 30 minutes of planned low to moderate intensity exercise 2 days per week\n\nExclusion Criteria:\n\n* Suicidal ideations\n* Current interferon therapy or planning to begin interferon therapy during the next three months\n* Diagnosis of Bipolar disorder, Schizophrenia, or Post Traumatic Stress Disorder\n* Any medical condition, disorder, or medication that contraindicates participation in a mild to moderate intensity walking program'}, 'identificationModule': {'nctId': 'NCT00643695', 'briefTitle': 'Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C', 'organization': {'class': 'FED', 'fullName': 'Portland VA Medical Center'}, 'officialTitle': 'Efficacy of an Exercise Intervention to Decrease Depressive Symptoms in Veterans With Hepatitis C', 'orgStudyIdInfo': {'id': '02101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Home-based walking program', 'interventionNames': ['Behavioral: Home-based walking program']}, {'type': 'OTHER', 'label': '2', 'description': 'educational intervention', 'interventionNames': ['Other: Educational intervention']}], 'interventions': [{'name': 'Home-based walking program', 'type': 'BEHAVIORAL', 'description': 'The exercise intervention is a 12 week home-based exercise program. Ideally Individuals will walk for 30 minutes, at a moderate intensity, a minimum of three times per week. However, the duration and relative intensity will be tailored for each individual.', 'armGroupLabels': ['1']}, {'name': 'Educational intervention', 'type': 'OTHER', 'description': 'Participants in the control group will receive a packet of information regarding hepatitis C', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portland VA Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Patricia Taylor-Young, PhD, RN,FNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Portland VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portland VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Scientist', 'investigatorFullName': 'Patricia Taylor-Young', 'investigatorAffiliation': 'Portland VA Medical Center'}}}}