Multidimensional Intervention in Early Osteoarthritis (The Knee Study)

Brief Summary

Detailed Description

There is no cure for arthritis; therefore, it is important to develop treatments to effectively manage the disease. The primary goals of arthritis management are to reduce pain and improve functional ability and quality of life. Existing treatments, including pain relievers and anti-inflammatory medications, can only partially manage OA symptoms. Few studies, however, have been conducted to evaluate complementary measures, such as exercise and education. This study will compare a physical training program, a self-management training program, and a program including both physical and self-management training to determine their effectiveness in improving physical function in people with early stage knee OA. Participants in this 2-year study will first undergo a physical evaluation that will include answering a questionnaire and having knee x-rays. Participants will then be randomly assigned to one of three treatment groups. All three treatments will include a 9-month supervised phase (Phase 1) and a 15-month maintenance phase (Phase 2). * Group 1 participants will partake in a community-based arthritis self-management program. Phase 1 will include weekly 75-minute training sessions for 3 months. These sessions will be led by healthcare professionals and will address topics about arthritis and its treatment, healthy lifestyle, and physical activity. After completing the training sessions, participants will be contacted weekly by telephone for 3 months to discuss their progress. Then the telephone contacts will occur once every other week for the next 3 months. During Phase 2 of the self-management training program, participants will continue to receive telephone contacts from the project team to help support and promote the skills introduced during the training sessions. These contacts will occur monthly for 3 months and then every other month for the remainder of the study. * Group 2 participants will first attend an orientation workshop and then start a long-term physical training program that will include components of balance, flexibility, muscle strengthening, and aerobic conditioning. During Phase 1, participants will attend three physical training sessions per week. During Phase 2, participants will have the option to continue the program in the location of their choice. Study staff will contact participants monthly by phone to discuss their progress. Participants may meet with the trainer on an as-needed basis for additional assistance with the program. They will also keep a log to track attendance and progress, and they will mail in the log monthly. * Group 3 participants will complete both the physical and self-management training programs and will follow the schedules outlined for Groups 1 and 2. All participants will complete questionnaires before beginning their assigned training programs and then every 3 months till Month 24. The questionnaires will take between 30 and 60 minutes to complete. At various times during the study, participants will measure their activity levels with a pedometer or an accelerometer. Prior to starting the training programs, at Month 9, and after completing the training programs, participants will complete several tests to measure their physical capabilities and muscle strength. Upon completing the training programs, participants will receive a follow-up x-ray of their knees at an assigned radiology clinic. They will also be asked to provide feedback on their study experiences via a mailer questionnaire, and they may be asked to provide feedback in a short telephone interview.

Primary Outcomes

Secondary Outcomes

• Pain, as measured by the visual analogue scale (VAS) and the Pain Subscale of the Western Ontario and MacMasters Universities (WOMAC)(Measured at baseline and Months 3, 9, 18, and 24)
• Coping efficacy, self-efficacy, and health-related quality of life, as measured by the Client Satisfaction Questionnaire (CSQ)(Measured at baseline and Months 3, 9, 18, and 24)
• Arthritis self-efficacy scale(Measured at baseline and Months 3, 9, 18, and 24)
• Positive and Negative Affect Schedule (PANAS)(Measured at baseline and Months 3, 9, 18, and 24)
• SF-36 Health Survey(Measured at baseline and Months 3, 9, 18, and 24)
• EuroQuol(Measured at baseline and Months 3, 9, 18, and 24)
• Medical Outcomes Social Support Survey(Measured at baseline and Months 3, 9, 18, and 24)