Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 12:23 AM
Study NCT ID:
NCT00526435
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2007-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Walk With Ease in Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-23', 'studyFirstSubmitDate': '2007-09-06', 'studyFirstSubmitQcDate': '2007-09-06', 'lastUpdatePostDateStruct': {'date': '2011-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Level', 'timeFrame': '6 weeks'}, {'measure': '6-minute walk', 'timeFrame': '6 weeks'}, {'measure': 'Walking behaviors', 'timeFrame': '6 weeks'}, {'measure': 'Exercise self-efficacy', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Health-related Quality of Life (SF36)'}, {'measure': 'Health Assessment Questionnaire'}, {'measure': 'Arthritis Symptoms'}, {'measure': 'Senior Fitness Test (function)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arthritis', 'osteoarthritis', 'rheumatoid arthritis', 'fibromyalgia', 'lupus'], 'conditions': ['Arthritis']}, 'descriptionModule': {'briefSummary': 'The overall goal of this study is to determine the whether the Walk with Ease (WWE) program in its 2 version (group-assisted and self-directed) can increase physical activity and fitness levels among individuals (18 years and older) with arthritis over the long-term. Participants will be approximately 657 subjects from 20-24 rural and urban communities across North Carolina. It is expected that participants in the WWE program will have reduced pain, improved function and increased activity levels after participation in this 6-week program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported, doctor-diagnosed arthritis\n* Ages 18+\n\nExclusion Criteria:\n\n* Non-English speaking\n* Severe impairment of physical or mental function\n* Co-existing condition for which exercise is contraindicated'}, 'identificationModule': {'nctId': 'NCT00526435', 'acronym': 'WWE', 'briefTitle': 'Evaluation of Walk With Ease in Arthritis', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'Evaluation of the Walk With Ease Program Among People With Arthritis', 'orgStudyIdInfo': {'id': 'CDC-NCCDPHP-AAMC-0975'}, 'secondaryIdInfos': [{'id': 'AAMC-0975'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group WWE', 'description': 'Subjects will participate in a group-assisted 6 week WWE program.', 'interventionNames': ['Behavioral: Walk with Ease - Group']}, {'type': 'EXPERIMENTAL', 'label': 'Self-directed', 'description': 'Subjects will follow the self-directed WWE program.', 'interventionNames': ['Behavioral: Walk with Ease - Self']}], 'interventions': [{'name': 'Walk with Ease - Group', 'type': 'BEHAVIORAL', 'description': 'Participate in 6-week, 1 hour per week group assisted classes (with instructor).', 'armGroupLabels': ['Group WWE']}, {'name': 'Walk with Ease - Self', 'type': 'BEHAVIORAL', 'description': 'SUbject will receive the WWE workbook and follow it without group/instructor assistance.', 'armGroupLabels': ['Self-directed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina - Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Jennifer M Hootman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Leigh F Callahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}]}}}