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| Tracking Information | |||||
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| First Received Date ICMJE | November 3, 1999 | ||||
| Last Updated Date | December 20, 2007 | ||||
| Start Date ICMJE | September 1977 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00000406 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Strength Training on Knee Osteoarthritis | ||||
| Official Title ICMJE | Effects of Strength Training on Knee Osteoarthritis (OA) | ||||
| Brief Summary | To understand the effects of leg strengthening exercise, we will study the effects of strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly with no OA or knee pain. In each of the first three groups, we will look at whether people who do strength training have less pain and/or slower progression of x-ray signs of OA over 30 months than people who perform nonstrengthening, range-of-motion exercises. We are including the fourth group to find out whether people with OA (groups 1 & 2) have the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 & 3) have the same response to training as those without joint pain. |
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| Detailed Description | Several studies have confirmed that weak leg muscles are associated with osteoarthritis (OA) of the knee. Studies of body composition in these people have also shown that, despite being weaker, people with OA have significantly greater muscle mass than those without OA, suggesting that those with OA may have the potential to greatly increase their strength. However, research has not clearly shown whether exercises designed to improve leg strength will decrease the severity of pain or slow the progression of OA based on radiographic (x-ray) analysis. To understand the effects of leg strengthening exercise, we will perform a randomized clinical trial of lower extremity strength training using four subgroups of people: (1) OA with knee pain; (2) OA without knee pain; (3) no OA with knee pain; and (4) normal elderly with no OA or knee pain. In each of the first three groups, we will determine whether people assigned to strength training have lower pain scores and/or slower progression of radiographic changes of OA over 30 months than controls who perform nonstrengthening exercises (i.e., range-of-motion exercises). We are including the fourth group to determine whether those with OA (groups 1 & 2) exhibit the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 & 3) have the same response to training as those without joint pain. We will also prospectively monitor changes in body composition and bone mass, quality of life, and symptoms of depression. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Osteoarthritis, Knee | ||||
| Intervention ICMJE | Procedure: Progressive resistance exercise | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Mikesky AE, Mazzuca SA, Brandt KD, Perkins SM, Damush T, Lane KA. Effects of strength training on the incidence and progression of knee osteoarthritis. Arthritis Rheum. 2006 Oct 15;55(5):690-9. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 280 | ||||
| Completion Date | November 2006 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000406 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P60 AR20582 Substudy EEHSR3, NIAMS-022 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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