Community-Based Programs for Improving Physical Function in People With Early Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is the most common joint-related disease and most prevalent form of
      arthritis in the United States. Pain relievers and anti-inflammatory medications are the most
      commonly prescribed treatments for OA. These medications, however, cannot completely
      alleviate OA symptoms. Additional recommended strategies for managing OA include physical and
      occupational therapy, exercise, and patient education. This study will compare the
      effectiveness of a physical training program, a self-management training program, and a
      program including both physical and self-management training for improving physical function
      in people with early stage knee OA.
    

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.
    

Intervention name(s): Physical training program; Self-management training program; Physical training and self-management training programs
Intervention type(s): Other; Behavioral; Other
Intervention description(s): The physical training will be completed in two phases. In Phase 1, which will last 9 months, participants will complete the program under the supervision of an experienced trainer. Sessions will occur three times each week in a designated study facility. The program will include the following components: stretching and balance, flexibility and range of motion, muscle strengthening, and aerobics. The program will also emphasize the importance of individualizing exercise regimens according to each person's specific needs (function and fitness). In Phase 2, the primary objective will be to promote long-term exercise (for up to 24 months from the time of study entry) that incorporates the four modalities of exercise instruction introduced in Phase 1, but on an independent basis.; The self-management training program is designed to target primarily coping skills and self-efficacy. This will be accomplished by using a variety of educational and behavioral methods. The program will be delivered in two phases. The initial 9-month phase will consist of 12 weekly 60-minute classroom sessions, followed by 24 weeks of a structured telephone intervention program. Phase 2 will continue to incorporate the telephone intervention program, at less frequent intervals, for up to 24 months from the time of study entry.; This "multidimensional" intervention will combine both the physical training and self-management training programs described for Groups 1 and 2.
Other intervention name(s): Exercise group; Combo Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee pain