Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00349869
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2006-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Yoga for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors masked to study condition'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2006-07-06', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Health', 'timeFrame': 'baseline, post intervention, follow-up', 'description': 'Assessed using SF36 Physical Component Score'}], 'secondaryOutcomes': [{'measure': 'Mobility/Fitness', 'timeFrame': 'baseline, posttest, follow-up', 'description': 'Change in flexibility, balance, strength, walk time'}, {'measure': 'RA Disease Activity', 'timeFrame': 'baseline, post intervention, follow-up', 'description': 'DAS28 CRP score'}, {'measure': 'Psychological Function', 'timeFrame': 'baseline, , posttest, follow-up', 'description': 'Change in SF36 MCS, CES-D, PANAS, Perceived Stress and Arthritis Self Efficacy'}, {'measure': 'HRQL', 'timeFrame': 'baseline, post intervention, follow-up', 'description': 'Change in SF36 domains'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['inflammatory arthritis', 'rheumatoid arthritis', 'knee osteoarthritis', 'arthritis', 'yoga'], 'conditions': ['Rheumatoid Arthritis', 'Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '24173693', 'type': 'RESULT', 'citation': 'Bartlett SJ, Moonaz SH, Mill C, Bernatsky S, Bingham CO 3rd. Yoga in rheumatic diseases. Curr Rheumatol Rep. 2013 Dec;15(12):387. doi: 10.1007/s11926-013-0387-2.'}, {'pmid': '21220084', 'type': 'RESULT', 'citation': 'Haaz S, Bartlett SJ. Yoga for arthritis: a scoping review. Rheum Dis Clin North Am. 2011 Feb;37(1):33-46. doi: 10.1016/j.rdc.2010.11.001. Epub 2010 Dec 3.'}, {'type': 'RESULT', 'citation': 'Haaz S, Bingham CO, Bathon JM, Bartlett SJ. The effect of yoga on clinical parameters in patients with rheumatoid arthritis. Arthritis & Rheumatism 2008;58:S893-S4.'}, {'type': 'RESULT', 'citation': 'Haaz S, Bingham III CO, Bartlett SJ. Adherence to an 8-week yoga program for RA and OA: Who drops out and why? Arthritis & Rheumatism 2009;60:1978.'}, {'pmid': '25834206', 'type': 'RESULT', 'citation': 'Moonaz SH, Bingham CO 3rd, Wissow L, Bartlett SJ. Yoga in Sedentary Adults with Arthritis: Effects of a Randomized Controlled Pragmatic Trial. J Rheumatol. 2015 Jul;42(7):1194-202. doi: 10.3899/jrheum.141129. Epub 2015 Apr 1.'}], 'seeAlsoLinks': [{'url': 'http://www.hopkinsarthritis.org/patient-corner/disease-management/yoga-for-arthritis/', 'label': 'Yoga for Arthritis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.', 'detailedDescription': 'Yoga is a set of ancient Indian theories and practices, focusing on unifying mind, body, and spirit, and promoting strength, balance, and flexibility. The physical aspect of yoga includes poses, breathing techniques, and relaxation. Inflammatory arthritis, a chronic disease characterized by inflammation of the lining of the joints, can cause long-term joint damage, resulting in chronic pain, loss of function, and disability.\n\nThe primary objective of this study is to learn how people with inflammatory arthritis and knee osteoarthritis respond to an exercise program of yoga. To accomplish this, 30 persons with inflammatory arthritis or knee osteoarthritis will be randomly assigned to one of two groups. Group one will begin an immediate 8-week program of yoga classes consisting of 60-minute sessions, twice a week. Group two, or the "waitlist" control group, will receive 8 weeks of arthritis education followed by the same 8-week yoga program as group one. Participants also will have blood drawn, and complete various tests. The yoga classes will be taught by an experienced, certified yoga instructor, and are designed especially for the needs of people with inflammatory arthritis and knee osteoarthritis.\n\nThis study will provide important data on integrating mind-body activities into the treatment of inflammatory arthritis and knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ (RA only upper age limit 70)\n* Confirmed or probable OA (using pre-specified criteria) OR Rheumatoid arthritis (participation approved by rheumatologist)\n* Currently sedentary (physically active for 20 min \\< 3times/week)\n\nExclusion Criteria:\n\n* Inability to ambulate without use of assistive device\n* Uncontrolled high blood pressure or existing heart condition\n* Co-morbid inflammatory condition with overlapping symptoms (i.e., fibromyalgia)\n* Surgery within 6 months'}, 'identificationModule': {'nctId': 'NCT00349869', 'briefTitle': 'Yoga for Rheumatoid Arthritis', 'nctIdAliases': ['NCT00346307'], 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Yoga for Persons With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'F31AT003362-01A1', 'link': 'https://reporter.nih.gov/quickSearch/F31AT003362-01A1', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'F31AT003362-01A1', 'link': 'https://reporter.nih.gov/quickSearch/F31AT003362-01A1', 'type': 'NIH'}, {'id': 'R24AT004641', 'link': 'https://reporter.nih.gov/quickSearch/R24AT004641', 'type': 'NIH'}, {'id': 'Doctoral Dissertation Award', 'type': 'OTHER', 'domain': 'Arthritis Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '8-week yoga program', 'interventionNames': ['Behavioral: yoga']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Usual care control'}], 'interventions': [{'name': 'yoga', 'type': 'BEHAVIORAL', 'description': '8-week yoga program.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Arthritis Center, 5501 Hopkins-Bayview Circle, Ste 1B.14', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Susan J. Bartlett, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Medicine, Johns Hopkins Rheumatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}