Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01172327
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2010-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Self-Directed Exercise Program for Adults With 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': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of arthritis', 'timeFrame': '12 weeks', 'description': 'Visual numeric scales to assess pain, fatigue, and stiffness'}, {'measure': 'Lower body strength', 'timeFrame': '12 weeks', 'description': 'The 30-second chair stand will assess lower body strength.'}, {'measure': 'Functional exercise capacity', 'timeFrame': '12 weeks', 'description': 'The six-minute walk will assess functional exercise capacity'}, {'measure': 'Flexibility', 'timeFrame': '12 weeks', 'description': 'The sit-and-reach test will assess flexibility'}, {'measure': 'Physical activity', 'timeFrame': '12 weeks', 'description': 'The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation'}, {'measure': 'Arthritis management self-efficacy', 'timeFrame': '12 weeks', 'description': 'The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms'}], 'secondaryOutcomes': [{'measure': 'Disability', 'timeFrame': '12 weeks', 'description': 'The Health Assessment Questionnaire (HAQ) will assess disability'}, {'measure': 'Upper body strength', 'timeFrame': '12 weeks', 'description': 'The grip strength test (kg/lbs of force) will assess upper body strength'}, {'measure': 'Balance', 'timeFrame': '12 weeks', 'description': 'Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse'}, {'measure': 'Gait', 'timeFrame': '12 weeks', 'description': 'GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity'}, {'measure': 'Depressive symptoms', 'timeFrame': '12 weeks', 'description': 'The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis', 'Osteoarthritis', 'Rheumatoid Arthritis', 'Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '28580795', 'type': 'DERIVED', 'citation': 'Baruth M, Wilcox S, Jake-Schoffman DE, Schlaff RA, Goldufsky TM. Effects of a Self-Directed Nutrition Intervention Among Adults With Chronic Health Conditions. Health Educ Behav. 2018 Feb;45(1):61-67. doi: 10.1177/1090198117709317. Epub 2017 Jun 3.'}, {'pmid': '25441237', 'type': 'DERIVED', 'citation': 'Wilcox S, McClenaghan B, Sharpe PA, Baruth M, Hootman JM, Leith K, Dowda M. The steps to health randomized trial for arthritis: a self-directed exercise versus nutrition control program. Am J Prev Med. 2015 Jan;48(1):1-12. doi: 10.1016/j.amepre.2014.08.006. Epub 2014 Nov 6.'}, {'pmid': '24392226', 'type': 'DERIVED', 'citation': 'Schoffman DE, Wilcox S, Baruth M. Association of body mass index with physical function and health-related quality of life in adults with arthritis. Arthritis. 2013;2013:190868. doi: 10.1155/2013/190868. Epub 2013 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effectiveness and safety of a self-directed physical activity program relative to a self-directed dietary program in adults with arthritis. A process evaluation will also be conducted to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction.', 'detailedDescription': 'Physical activity is a critical component of arthritis disease management. It also reduces the risk for other chronic comorbid conditions in people with arthritis. Yet, most adults with arthritis are not sufficiently active at the level needed to achieve benefits. Existing group-based arthritis exercise programs reach only a very small percentage of the population. The overall purpose of this study is to test a self-directed and low-cost multicomponent physical activity program for people with arthritis on outcomes including symptoms of arthritis, lower body strength, functional aerobic capacity, flexibility, physical activity, arthritis self-efficacy and disability, upper body strength, balance, gait, and depressive symptoms. The second primary aim is to evaluate the safety of the physical activity program. The third primary aim is to conduct a process evaluation to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction. Adults aged 18 years and older with arthritis will be recruited from the midlands area of South Carolina. After completion of a baseline visit, participants will be randomized in equal numbers to the 12-week physical activity program (First Step to Active Health®) or the 12-week attention-control group (Steps to Healthy Eating). The attention control intervention will have the same "look and feel" as the physical activity intervention and will require similar activities such as self-monitoring of behavior. Follow-up measurements will take place post-program (12-weeks) and 6 months post-program (i.e., 9 months post-randomization). If First Step to Active Health® is shown to be effective, it could be widely disseminated for a very low cost, thus having the potential to make a tremendous public health impact on the burden of arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported, health care provider-diagnosed arthritis (CDC definition)\n* 18+ years of age\n* Self-reported symptoms of joint pain, stiffness, tenderness, decreased range of motion, redness and warmth, deformity, crackling or grating, or fatigue\n* Able to read and write in English\n\nExclusion Criteria:\n\n* Another member of household is participating in study\n* Plans to move from the Columbia, SC area in the next 9 months\n* Unable to walk longer than 3 minutes without taking a rest\n* Unable to stand without assistance for more than 2 minutes\n* Cannot sit in a chair without arms for more than 5 minutes\n* Measured resting blood pressure \\>160/100\n* Positive response to PAR-Q question(s)\n* Had a fall in the past year that required medical assistance\n* Pregnant or breastfeeding\n* Uses insulin to manage diabetes\n* Participating in another research study that includes an intervention or drug\n* Participates in 3+ days of structured moderate-intensity exercise for 30+ minutes per day\n* Participates in 2+ days of strength building exercises for 20+ minutes per day'}, 'identificationModule': {'nctId': 'NCT01172327', 'briefTitle': 'Self-Directed Exercise Program for Adults With Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis', 'orgStudyIdInfo': {'id': 'Pro00004658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multicomponent exercise', 'description': 'This arm is a self-directed, multicomponent, exercise intervention. Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises. Participants also complete a daily log of their exercises and return the logs every week for 12 weeks.', 'interventionNames': ['Behavioral: Multicomponent exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition', 'description': 'This arm is a self-directed nutrition intervention. Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans. Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks.', 'interventionNames': ['Behavioral: Nutrition']}], 'interventions': [{'name': 'Multicomponent exercise', 'type': 'BEHAVIORAL', 'description': 'This intervention is a self-directed, multicomponent, exercise intervention. Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises. Participants also complete a daily log of their exercises and return the logs every week for 12 weeks. The active intervention phase is 12 weeks.', 'armGroupLabels': ['Multicomponent exercise']}, {'name': 'Nutrition', 'type': 'BEHAVIORAL', 'description': 'This arm is a self-directed nutrition intervention. Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans. Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks. The active intervention lasts for 12 weeks.', 'armGroupLabels': ['Nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'University of South Carolina Prevention Research Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'overallOfficials': [{'name': 'Sara Wilcox, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sara Wilcox', 'investigatorAffiliation': 'University of South Carolina'}}}}