A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis (KBA Exercise)
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| First Received Date ICMJE | August 21, 2007 | ||||||||||||
| Last Updated Date | July 21, 2008 | ||||||||||||
| Start Date ICMJE | January 2008 | ||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
WOMAC Osteoarthritis Scale; Function subscale change pre to post intervention - KBA vs. standard strength training [ Time Frame: 8 weeks ] | ||||||||||||
| Change History | Complete list of historical versions of study NCT00519922 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | A Study of the Effectiveness of Different Types of Exercise for People With Knee Osteoarthritis | ||||||||||||
| Official Title ICMJE | Efficacy of Kinesthesia, Balance and Agility Exercise Training as Treatment of Knee Osteoarthritis: A Pilot Study | ||||||||||||
| Brief Summary | This pilot study will test the testing and exercise training protocols for a larger study that is in the desing phase and may be modified based on the findings of this study. Two exercise groups will be compared; one is a stadard treatment group using leg strength exercises that are commonly employed in therapy clinics. The other group will do balance and agility type exercises, but no specific strength exercises. These "KBA" exercises are increasingly common in therapy clinics, but very little research has been conducted on their effectiveness in treating knee osteoarthritis symptoms. Participants in this study will complete three short paper and pencil tests at the beginning and end of the study (8 weeks of exercise) as well as a leg strength test, a leg endurance test, two short walking tests, and a stair climb/descend test. One of the paper and pencil tests will be taken every two weeks in an effort to see how quickly changes to symptoms might occur. The exercise programs will be conducted 3 afternoons per week (Mon-Wed-Fri) and will be lead by an ACSM certified instructor. |
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| Detailed Description | Radiographic knee OA is present in an estimated 37% of Americans over the age of 60, representing more than 13 million people. Current medical, non-surgical knee OA treatments focus primarily on symptomatic relief and have met with limited, temporary success. Various therapeutic exercise prescriptions have been used to help ameliorate knee OA symptoms and improve function. Leg strength training is most commonly used. However, recent evidence suggests that shorter programs of kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. These early benefits could potentially lead to greater long term exercise adherence. In a case study of an elderly female patient with dynamic knee instability related to OA, physical therapists reported success with a combination of KBA training and traditional therapeutic exercise. These findings need to be verified in a controlled clinical trial. This pilot study will help determine the proper testing and exercise training methods for a larger clinical trial, and will indicate if KBA training done without concurrent strength training is a viable intervention. Research Hypothesis: Among men and women age 50 and over with Kellgren and Lawrence (1957) Grade 2 or higher symptomatic tibiofemoral OA in one or both knees, an 8-week, 3-day per week kinesthesia, balance & agility (KBA) exercise program - designed to increase dynamic neuromuscular knee stability - safely and effectively changes physical function more effectively than standard leg strength training |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Knee Osteoarthritis | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||||||
| Completion Date | July 2008 | ||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 50 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00519922 | ||||||||||||
| Other Study ID Numbers ICMJE | KneeOAExercise-1 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Matthew W Rogers, Director of Exercise Research, The Arthritis Research Institute of America | ||||||||||||
| Study Sponsor ICMJE | The Arthritis Research Institute of America | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | The Arthritis Research Institute of America | ||||||||||||
| Verification Date | July 2008 | ||||||||||||
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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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