OBJECTIVE: This 8 week randomized, double blind clinical trial compared the effect of a combined home based progressive exercise program and treatment with the nonsteroidal medication oxaprozin to treatment with oxaprozin alone on pain and physical functioning in older community dwelling patients with unilateral knee osteoarthritis (OA). METHODS: Efficacy variables measured before and after 8 weeks included (1) pain using the Western Ontario McMaster (WOMAC) pain, physical disability, and stiffness subscales and a 10 point visual analog scale (VAS) before and after self-paced walking (SPW) and stepping (SPS) functional tasks; (2) physical function using the time to complete a self-paced 40 m walk (SPW) and 20 cycles of 2 steps (SPS): (3) physical activity level using the Physical Activity Scale for Elderly (PASE); (4) clinical measures of knee functioning (range of motion). One hundred seventy-nine men and women (mean age 74 +/- 6 yrs) with radiographic evidence of mild/moderate medial compartment OA were randomized to either a progressive home based knee exercise program (n = 88) or a control program (n = 89). All patients were given oxaprozin 1,200 mg per os daily. RESULTS: We observed significant reduction from baseline in activity related pain (VAS); and improvement in SPW and SPS test time, passive range of motion, and PASE after 8 weeks in both groups. These changes were significantly greater (p < 0.05) in the exercise versus sham group. CONCLUSION: Addition of a progressive exercise program to nonsteroidal antiinflammatory therapy in patients with knee OA can improve measures of activity and activity related pain more than medication alone.

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