Nctid:
NCT00000434
Payload:
{"FullStudy"=>{"Rank"=>473965, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000010003", "ConditionMeshTerm"=>"Osteoarthritis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000001168", "ConditionAncestorTerm"=>"Arthritis"}, {"ConditionAncestorId"=>"D000007592", "ConditionAncestorTerm"=>"Joint Diseases"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000012216", "ConditionAncestorTerm"=>"Rheumatic Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M12616", "ConditionBrowseLeafName"=>"Osteoarthritis", "ConditionBrowseLeafAsFound"=>"Osteoarthritis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4166", "ConditionBrowseLeafName"=>"Arthritis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10311", "ConditionBrowseLeafName"=>"Joint Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14735", "ConditionBrowseLeafName"=>"Rheumatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6013", "ConditionBrowseLeafName"=>"Collagen Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Skin and Connective Tissue Diseases", "ConditionBrowseBranchAbbrev"=>"BC17"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Prevention", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"217"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1983"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2007", "CompletionDateStruct"=>{"CompletionDate"=>"September 2003", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"August 20, 2019", "StudyFirstSubmitDate"=>"January 21, 2000", "StudyFirstSubmitQCDate"=>"January 21, 2000", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"August 22, 2019", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"January 24, 2000", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"September 2003", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Adherence to exercise", "PrimaryOutcomeTimeFrame"=>"12 months"}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Pain and stiffness", "SecondaryOutcomeTimeFrame"=>"12 months"}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Osteoarthritis", "Health education", "Aerobic exercise", "Self-efficacy", "Muscle strength", "Outcomes research", "Longitudinal study"]}, "ConditionList"=>{"Condition"=>["Osteoarthritis"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"15075418", "ReferenceType"=>"background", "ReferenceCitation"=>"Hughes SL, Seymour RB, Campbell R, Pollak N, Huber G, Sharma L. Impact of the fit and strong intervention on older adults with osteoarthritis. Gerontologist. 2004 Apr;44(2):217-28. doi: 10.1093/geront/44.2.217."}, {"ReferencePMID"=>"17169935", "ReferenceType"=>"background", "ReferenceCitation"=>"Hughes SL, Seymour RB, Campbell RT, Huber G, Pollak N, Sharma L, Desai P. Long-term impact of Fit and Strong! on older adults with osteoarthritis. Gerontologist. 2006 Dec;46(6):801-14. doi: 10.1093/geront/46.6.801."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising.\n\nWe will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.", "DetailedDescription"=>"Recent exercise interventions have demonstrated statistically significant short-term improvements in muscle strength, fitness, and physical activity in people under the age of 70. This study seeks to determine if those same benefits can be achieved in an older population (mean age 84) with osteoarthritis of the hip or knee. The study will examine the long-term effects of a structured exercise program that seeks to promote adherence to continued exercise.\n\nWe will randomly assign people who meet the study criteria to the exercise intervention or control group. We will conduct measures at baseline, at 8 weeks, and at 3-month intervals for 2 years following the intervention. The exercise component of the intervention will include lower extremity muscle strengthening, range-of-motion exercises, and fitness walking. An educational component will focus on arthritis self-efficacy and perceived self-reported exercise efficacy. We hypothesize that treatment group participants will exhibit higher rates of adherence to exercise and higher functional status outcomes over time compared to controls."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"60 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\n60 years of age or older\nPresence of osteoarthritis of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III\nNo other contraindication from a personal physician for participation in the fitness walking\nLack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire\n\nExclusion Criteria:\n\nUnder 60 years of age\nLack of osteoarthritis of the lower extremities\nContraindication from a personal physician for participation in fitness walking\nPresence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire\nSteroid injections in either hip or knee within the previous 6 months\nUncomplicated knee or hip surgery within previous year\nComplicated knee or hip surgery within previous year\nPlans for total knee or hip replacement within the next year\nRheumatoid arthritis or other systemic inflammatory arthritis\nDiabetes that is not under control\nCurrent participation in a structured aerobic exercise program"}, "IdentificationModule"=>{"NCTId"=>"NCT00000434", "BriefTitle"=>"Impact of Exercise on Older Persons With Osteoarthritis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)"}, "OfficialTitle"=>"Impact of Exercise on Older Persons With Osteoarthritis (OA)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"P60AR030692", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/P60AR030692", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"NIAMS-050"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Fit and Strong!"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Fit and Strong!", "InterventionType"=>"Behavioral", "InterventionDescription"=>"Fit and Strong! is a multi-component exercise and health education program that includes flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"60646", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"North Park Village"}, {"LocationZip"=>"60659", "LocationCity"=>"Chicago", "LocationState"=>"Illinois", "LocationCountry"=>"United States", "LocationFacility"=>"Bernard Horwich Jewish Community Center"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Susan Hughes", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Center for Research on Health and Aging"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "LeadSponsorClass"=>"NIH"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute on Aging (NIA)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyOldNameTitle"=>"Susan Hughes", "ResponsiblePartyOldOrganization"=>"Center for Research on Health and Aging, UIC"}}}}}}
