Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-21 @ 6:12 PM
Study NCT ID:
NCT02631005
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Walk With Ease Program For Patients With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'C034430', 'term': 'methyl hydroxyethyl cellulose'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-12-11', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analog Scale (VAS) Pain Score from Baseline to Six Weeks', 'timeFrame': '6 weeks', 'description': 'Pain scale ranges from 0 millimeters (mm) (no pain) to 100 mm (worst pain imaginable). An increase in score indicates worsening pain, while a decrease represents a response to the intervention.'}, {'measure': 'Change in VAS Stiffness Score from Baseline to Six Weeks', 'timeFrame': '6 weeks', 'description': 'Stiffness scale ranges from 0 millimeters (mm) (no stiffness) to 100 mm (worst stiffness imaginable). An increase in score indicates worsening stiffness, while a decrease represents a response to the intervention.'}, {'measure': 'Change in VAS Fatigue Score from Baseline to Six Weeks', 'timeFrame': '6 weeks', 'description': 'Fatigue scale ranges from 0 millimeters (mm) (no fatigue) to 100 mm (worst fatigue imaginable)An increase in score indicates worsening fatigue, while a decrease represents a response to the intervention.'}, {'measure': 'Change in FACIT-Fatigue Score from Baseline to Six Weeks', 'timeFrame': '6 weeks', 'description': 'This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.'}], 'secondaryOutcomes': [{'measure': 'Participant Satisfaction with Walk With Ease', 'timeFrame': '6 weeks', 'description': 'This survey was designed by the Arthritis Foundation to assess participant satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['systemic lupus erythematosus', 'exercise'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '18163481', 'type': 'BACKGROUND', 'citation': 'Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008 Jan;58(1):15-25. doi: 10.1002/art.23177.'}, {'pmid': '15333286', 'type': 'BACKGROUND', 'citation': 'Ward MM. Prevalence of physician-diagnosed systemic lupus erythematosus in the United States: results from the third national health and nutrition examination survey. J Womens Health (Larchmt). 2004 Jul-Aug;13(6):713-8. doi: 10.1089/jwh.2004.13.713.'}, {'pmid': '24532834', 'type': 'BACKGROUND', 'citation': 'Bartels CM, Buhr KA, Goldberg JW, Bell CL, Visekruna M, Nekkanti S, Greenlee RT. Mortality and cardiovascular burden of systemic lupus erythematosus in a US population-based cohort. J Rheumatol. 2014 Apr;41(4):680-7. doi: 10.3899/jrheum.130874. Epub 2014 Feb 15.'}, {'pmid': '16868977', 'type': 'BACKGROUND', 'citation': 'Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.'}, {'pmid': '25209070', 'type': 'BACKGROUND', 'citation': 'Lerang K, Gilboe IM, Steinar Thelle D, Gran JT. Mortality and years of potential life loss in systemic lupus erythematosus: a population-based cohort study. Lupus. 2014 Dec;23(14):1546-52. doi: 10.1177/0961203314551083. Epub 2014 Sep 10.'}, {'pmid': '11604587', 'type': 'BACKGROUND', 'citation': 'Trager J, Ward MM. Mortality and causes of death in systemic lupus erythematosus. Curr Opin Rheumatol. 2001 Sep;13(5):345-51. doi: 10.1097/00002281-200109000-00002.'}, {'pmid': '2590802', 'type': 'BACKGROUND', 'citation': 'Robb-Nicholson LC, Daltroy L, Eaton H, Gall V, Wright E, Hartley LH, Schur PH, Liang MH. Effects of aerobic conditioning in lupus fatigue: a pilot study. Br J Rheumatol. 1989 Dec;28(6):500-5. doi: 10.1093/rheumatology/28.6.500.'}, {'pmid': '8542209', 'type': 'BACKGROUND', 'citation': 'Daltroy LH, Robb-Nicholson C, Iversen MD, Wright EA, Liang MH. Effectiveness of minimally supervised home aerobic training in patients with systemic rheumatic disease. Br J Rheumatol. 1995 Nov;34(11):1064-9. doi: 10.1093/rheumatology/34.11.1064.'}, {'pmid': '14635294', 'type': 'BACKGROUND', 'citation': 'Ramsey-Goldman R, Schilling EM, Dunlop D, Langman C, Greenland P, Thomas RJ, Chang RW. A pilot study on the effects of exercise in patients with systemic lupus erythematosus. Arthritis Care Res. 2000 Oct;13(5):262-9. doi: 10.1002/1529-0131(200010)13:53.0.co;2-8.'}, {'pmid': '12730519', 'type': 'BACKGROUND', 'citation': "Tench CM, McCarthy J, McCurdie I, White PD, D'Cruz DP. Fatigue in systemic lupus erythematosus: a randomized controlled trial of exercise. Rheumatology (Oxford). 2003 Sep;42(9):1050-4. doi: 10.1093/rheumatology/keg289. Epub 2003 Apr 16."}, {'pmid': '15818657', 'type': 'BACKGROUND', 'citation': 'Clarke-Jenssen AC, Fredriksen PM, Lilleby V, Mengshoel AM. Effects of supervised aerobic exercise in patients with systemic lupus erythematosus: a pilot study. Arthritis Rheum. 2005 Apr 15;53(2):308-12. doi: 10.1002/art.21082. No abstract available.'}, {'pmid': '16342102', 'type': 'BACKGROUND', 'citation': 'Carvalho MR, Sato EI, Tebexreni AS, Heidecher RT, Schenkman S, Neto TL. Effects of supervised cardiovascular training program on exercise tolerance, aerobic capacity, and quality of life in patients with systemic lupus erythematosus. Arthritis Rheum. 2005 Dec 15;53(6):838-44. doi: 10.1002/art.21605.'}, {'pmid': '21700656', 'type': 'BACKGROUND', 'citation': 'Yuen HK, Holthaus K, Kamen DL, Sword DO, Breland HL. Using Wii Fit to reduce fatigue among African American women with systemic lupus erythematosus: a pilot study. Lupus. 2011 Oct;20(12):1293-9. doi: 10.1177/0961203311412098. Epub 2011 Jun 23.'}, {'pmid': '22651371', 'type': 'BACKGROUND', 'citation': 'Eriksson K, Svenungsson E, Karreskog H, Gunnarsson I, Gustafsson J, Moller S, Pettersson S, Bostrom C. Physical activity in patients with systemic lupus erythematosus and matched controls. Scand J Rheumatol. 2012 Aug;41(4):290-7. doi: 10.3109/03009742.2011.624117. Epub 2012 May 31.'}, {'pmid': '21183562', 'type': 'BACKGROUND', 'citation': 'Mancuso CA, Perna M, Sargent AB, Salmon JE. Perceptions and measurements of physical activity in patients with systemic lupus erythematosus. Lupus. 2011 Mar;20(3):231-42. doi: 10.1177/0961203310383737. Epub 2010 Dec 23.'}, {'pmid': '21560255', 'type': 'BACKGROUND', 'citation': "Callahan LF, Shreffler JH, Altpeter M, Schoster B, Hootman J, Houenou LO, Martin KR, Schwartz TA. Evaluation of group and self-directed formats of the Arthritis Foundation's Walk With Ease Program. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1098-107. doi: 10.1002/acr.20490."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook. The book provides guidance about walking safety as well as how to start, build-up, and maintain a walking program. Participants will complete questionnaires assessing their symptoms before and after completing the six-week program.', 'detailedDescription': 'The purpose of this study is to evaluate the effects of "Walk With Ease", a moderate-intensity exercise program, on pain, stiffness, and fatigue caused by lupus. Participants will receive a copy of the "Walk With Ease" workbook, a publication of the Arthritis Foundation. Participants will complete self-reported outcomes questionnaires prior to beginning the program and six weeks later at completion of the program. The questionnaires will include visual analog scales for pain, stiffness, and fatigue as well as a FACIT-Fatigue form. Participants will also complete a satisfaction survey at the end of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician diagnosis of systemic lupus erythematosus\n* Age \\>/= 18\n\nExclusion Criteria:\n\n* Age \\<18\n* Engagement in \\>150 minutes of moderate-intensity activity at baseline\n* Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score \\>8\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02631005', 'acronym': 'Walk SLE', 'briefTitle': 'Walk With Ease Program For Patients With Systemic Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Walk With Ease Program For Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': '15-2738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Walk With Ease Participants', 'description': 'Participants will receive a copy of the "Walk With Ease" workbook. This workbook provides guidance on walking safety and on how to start and maintain a regular walking program. It is designed to help participants increase their physical activity over a six-week period. Participants will complete self-reported outcomes questionnaires before and after completion of the program.', 'interventionNames': ['Other: "Walk With Ease"']}], 'interventions': [{'name': '"Walk With Ease"', 'type': 'OTHER', 'description': 'Six-week walking program', 'armGroupLabels': ['Walk With Ease Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27517', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Rheumatology Clinic', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Saira Sheikh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Leigh Callahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Katherine Kaufman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}