OBJECTIVE:To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis.SETTING AND DESIGN:A randomized, single-blind clinical trial lasting 18 months conducted at 2 academic medical centers.PARTICIPANTS:A total of 439 community-dwelling adults, aged 60 years or older, with radiographically evident knee osteoarthritis, pain, and self-reported physical disability.INTERVENTIONS:An aerobic exercise program, a resistance exercise program, and a health education program.MAIN OUTCOME MEASURES:The primary outcome was self-reported disability score (range, 1-5). The secondary outcomes were knee pain score (range, 1-6), performance measures of physical function, x-ray score, aerobic capacity, and knee muscle strength.RESULTS:A total of 365 (83%) participants completed the trial. Overall compliance with the exercise prescription was 68% in the aerobic training group and 70% in the resistance training group. Postrandomization, participants in the aerobic exercise group had a 10% lower adjusted mean (+/- SE) score on the physical disability questionnaire (1.71 +/- 0.03 vs 1.90 +/- 0.04 units; P<.001), a 12% lower score on the knee pain questionnaire (2.1 +/- 0.05 vs 2.4 +/- 0.05 units; P=.001), and performed better (mean [+/- SE]) on the 6-minute walk test (1507 +/- 16 vs 1349 +/- 16 ft; P<.001), mean (+/-SE) time to climb and descend stairs (12.7 +/- 0.4 vs 13.9 +/- 0.4 seconds; P=.05), time to lift and carry 10 pounds (9.1 +/- 0.2 vs 10.0 +/- 0.1 seconds; P<.001), and mean (+/-SE) time to get in and out of a car (8.7 +/- 0.3 vs 10.6 +/- 0.3 seconds; P<.001) than the health education group. The resistance exercise group had an 8% lower score on the physical disability questionnaire (1.74 +/- 0.04 vs 1.90 +/- 0.03 units; P=.003), 8% lower pain score (2.2 +/- 0.06 vs 2.4 +/- 0.05 units; P=.02), greater distance on the 6-minute walk (1406 +/- 17 vs 1349 +/- 16 ft; P=.02), faster times on the lifting and carrying task (9.3 +/- 0.1 vs 10.0 +/- 0.16 seconds; P=.001), and the car task (9.0 +/- 0.3 vs 10.6 +/- 0.3 seconds; P=.003) than the health education group. There were no differences in x-ray scores between either exercise group and the health education group.CONCLUSIONS:Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability, physical performance, and pain from participating in either an aerobic or a resistance exercise program. These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis.
Study Objective. To evaluate the efficacy and safety of a new combination product, enalapril-diltiazem ER, when administered over the long term.Design. Open-label, titration to response, with treatment lasting 46 weeks after a 6-week, double-blind phase.Setting. Medical clinics in the private and academic sectors.Patients. Of 265 patients (68% men, 83% Caucasian, mean age 54.9 yrs) with essential hypertension (sitting diastolic blood pressure 95-115 mm Hg) enrolled, 167 completed the trial.Interventions. Patients received either the dosage of enalapril-diltiazem ER that they were given during the double-blind phase, or were prescribed enalapril 5 mg-diltiazem ER 120 mg once/day. The dosage was increased until blood pressure was controlled or to a maximum of enalapril 10-diltiazem ER 360 mg/day.Measurements and Main Results. Combination therapy decreased sitting blood pressures by -11.1/-10.6 mm Hg. Overall, 58% of the patients achieved a sitting diastolic blood pressure of 90 mm Hg or below at the end of the study. There was no evidence of tolerance to the agents' antihypertensive effects. The most common drug-related adverse events were cough, headache, dizziness, and asthenia or fatigue.Conclusion. The combination effectively managed essential hypertension when administered on a long-term basis and was generally well tolerated. It should improve both compliance and management of hypertension.
BACKGROUND:Total and lipoprotein cholesterol levels continue to be predictors of coronary heart disease risk in men and women over 65 years old. Cholesterol-lowering trials, however, while sometimes including such subjects, have not concentrated on this age group. The Cholesterol Reduction in Seniors Program was a five-center pilot study to assess feasibility of recruitment and efficacy of cholesterol lowering in this age group.METHODS:The study was a randomized, double-masked clinical trial with placebo, 20-mg lovastatin, and 40-mg lovastatin arms. Major efforts were made to recruit women and minorities. Participants were followed up for 1 year on a cholesterol-lowering diet plus placebo or study drug. End points were changes in blood lipid levels. Data on other blood chemistry values, as well as quality-of-life measures and coronary heart disease morbidity and mortality, were also collected.RESULTS:Four hundred thirty-one subjects with low-density lipoprotein cholesterol levels greater than 4.1 and less than 5.7 mmol/L (159 and 221 mg/dL) were randomized, of whom 71% were women and 21% were African Americans; the mean age was 71 years. In the 20- and 40-mg lovastatin groups, total cholesterol levels fell 17% and 20%; low-density lipoprotein cholesterol levels fell 24% and 28%; triglyceride levels fell 4.4% and 9.9%, respectively. High-density lipoprotein cholesterol levels rose 7.0% and 9.0%, respectively. No changes were observed in the placebo group. Gender, race, and age did not significantly affect responses. Coronary heart disease morbidity and mortality data were collected but not analyzed for this study.CONCLUSION:Older subjects of both genders and a variety of racial and ethnic groups can be successfully recruited into a cholesterol-lowering trial. Lovastatin has effects similar to those reported in younger subjects in previous controlled trials. There is little advantage to the higher lovastatin daily dose. Side effects were remarkably low in all groups.
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