Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design.

BACKGROUND: Diary recording of pain and disabling activities in osteoarthritis (OA) is widely recommended, but, to our knowledge, its impact on symptoms has not been investigated. Exercise programmes have been shown to be effective when patients are closely supervised by nurses or physiotherapists; however, data are lacking on the efficacy of an unsupervised home based exercise regimen in patients with OA. OBJECTIVES: To evaluate the clinical efficacy of patient administered assessment tools and an unsupervised home based exercise programme alone or in combination in patients with OA. METHODS: The study was a 24 week, open cluster randomised controlled trial with a factorial design. Rheumatologists (n = 867) were assigned to four groups according to the treatment given: standardised tools (ST; n = 220), exercises (EX; n = 213), both tools and exercises (ST+EX; n = 213), or usual care (n = 221). Each rheumatologist was to enroll four patients who met the American College of Rheumatology criteria for OA (three with knee OA, one with hip OA). "Tools" consisted of weekly recording of pain and disabling activities in a diary. A home based exercise programme was performed daily at least four times per week with the aid of videotape and booklet. In addition to exercise and assessment, all patients received 12.5 mg or 25 mg of the non-steroidal anti-inflammatory drug rofecoxib once daily. Outcome variables were: pain (measured on a visual analogue scale, 0-100); Western Ontario and McMaster Universities Osteoarthritis Index, function subscale (0-100); and patient assessment of the quality of care (0-100). RESULTS: Overall, 2957 patients with OA (2216 knee, 741 hip) were included. After 24 weeks, both pain and function improved in the ST, EX, ST+EX, and usual care groups (mean (SD) -17 (27), -20 (29), -15 (27), -19 (29); and -11 (19), -12 (19), -10 (19), -11 (20), respectively), without significant differences between groups. However, patients in the EX and ST+EX groups were more likely to agree that their rheumatologist had done his best to preserve their functional and physical activities. CONCLUSION: Although patients' assessments favoured the exercise programme, results from this study failed to demonstrate a short term symptomatic effect of the two non-pharmacological treatments (weekly recording of condition and exercise) in patients with OA concurrently receiving nonsteroidal anti-inflammatory drugs.

[Survey on adherence to hygiene and dietary rules in patients with arterial occlusive disease]. / Enquête sur les conditions de suivi des règles hygiéno-diététiques chez l'artériopathe.

OBJECTIVE: Chronic arterial occlusive disease of the lower limbs, a common (800,000 patients in France) invalidating condition, can involve one or more arterial territories. In 90% of the cases, it is related to a more general disease, atherosclerosis. The risk factors are the same as for atherosclerosis and can be classed into three distinct groups: pathological conditions, constitutional characteristics, and lifestyle. Besides age and gender, smoking habits are by far the most predominant vascular risk factor for chronic arterial occlusive disease. Other factors include diabetes, known to play a particular role in diabetic arteriopathy, generally with more distal and quite severe lesions, high blood pressure, a less evident but certain risk factor, and hyperlipidemia, whole role in the pathogenesis of chronic arterial occlusive disease is well recognized though not predominant. These different data led us to analyze a cohort of patients with chronic arterial occlusive disease of the lower limbs to ascertain the cause of success or failure of hygiene and diet counseling. PATIENTS AND METHODS: The study protocol included three steps. We first established the profile of a typical arteriopathy patient based on demographic data, history of the arterial disease, personal and familial medical history and lifestyle: smoking habits, physical exercise, diet. The second step was to estimate the proportion of patients following hygiene and dietary rules. Finally, we looked for the reasons why the patients succeeded or failed in following these rules. This cross-sectional study involved 1,500 practitioners. Each physician selected 3 patients, men or women aged 40 to 80 years whose arteriopathy had reached the stage of intermittent claudication. Evaluation criteria were based on the demographic data and conditions of adherence to advice as well as conditions leading to success or failure: personal motivation, familial support, the patient's knowledge of the disease, its pathophysiological mechanisms, and the way the risk factors contribute to its genesis and aggravation. RESULTS: The sex ratio of the 3,294 recruited patients was 4.3 (2,672 men and 622 women). Disease duration and walking distance were 8.6 +/- 6 years and 418 +/- 297 meters respectively. Thirty-eight percent of the patients had undergone surgery of the lower limbs. One thousand four hundred ninety-four patients (45%) had undergone surgery for their arterial disease (lower limbs, coronary or cerebral arteries). Forty-nine percent were aware of the risk of amputation. Overall adherence to drug therapy was good for 82% of the patients. Patients were treated basically with vasoactive and platelet antiaggregates (95 and 82% of the patients respectively). Seventy-nine percent of the patients were former smokers (38% continued to smoke). Fifty-six percent had a specific regular physical activity compared with 42% prior to their disease. Seventeen percent of the patients had already tried a Mediterranean type diet (with a success rate of 69%). Among the 3, 294 patients, 950 (28.8%) followed hygiene and dietary rules well. The main reasons and/or conditions differentiating those who were successful and those who were not were, for each item: personal motivation, family support, and perception of the influence of lifestyle on disease course. These differences were highly significant (p <0.001). CONCLUSION: Considering the importance of following good hygiene and dietary rules for secondary prevention of chronic arterial occlusive disease of the lower limbs, it was interesting to assess with precision the percentage of diseased patients who follow such rules. Only about 30% of the patients were successful in correcting all behaviors.