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Single-blind Trial (single-blind + trial)
Selected AbstractsEndurance Exercise Training in Older Patients with Heart Failure: Results from a Randomized, Controlled, Single-Blind TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 11 2009Peter H. Brubaker PhD OBJECTIVES: To test the hypothesis that exercise training (ET) improves exercise capacity and other clinical outcomes in older persons with heart failure with reduced ejection fraction (HfrEF). DESIGN: Randomized, controlled, single-blind trial. SETTING: Outpatient cardiac rehabilitation program. PARTICIPANTS: Fifty-nine patients aged 60 and older with HFrEF recruited from hospital records and referring physicians were randomly assigned to a 16-week supervised ET program (n=30) or an attention-control, nonexercise, usual care control group (n=29). INTERVENTION: Sixteen-week supervised ET program of endurance exercise (walking and stationary cycling) three times per week for 30 to 40 minutes at moderate intensity regulated according to heart rate and perceived exertion. MEASUREMENTS: Individuals blinded to group assignment assessed four domains pivotal to HFrEF pathophysiology: exercise performance, left ventricular (LV) function, neuroendocrine activation, and health-related quality of life (QOL). RESULTS: At follow-up, the ET group had significantly greater exercise time and workload than the control group, but there were no significant differences between the groups for the primary outcomes: peak exercise oxygen consumption (VO2 peak), ventilatory anaerobic threshold (VAT), 6-minute walk distance, QOL, LV volumes, EF, or diastolic filling. Other than serum aldosterone, there were no significant differences after ET in other neuroendocrine measurements. Despite a lack of a group "training" effect, a subset (26%) of individuals increased VO2 peak by 10% or more and improved other clinical variables as well. CONCLUSION: In older patients with HFrEF, ET failed to produce consistent benefits in any of the four pivotal domains of HF that were examined, although the heterogeneous response of older patients with HFrEF to ET requires further investigation to better determine which patients with HFrEF will respond favorably to ET. [source] Periodontal therapy: a novel non-drug-induced experimental model to study human inflammationJOURNAL OF PERIODONTAL RESEARCH, Issue 5 2004F. D'Aiuto Background:, Chronic periodontitis causes a low-grade systemic inflammatory response; its standard treatment, however, induces an acute inflammatory response. The aim of this study was to describe the systemic inflammatory reactions to an intensive periodontal treatment regimen. Methods:, Fourteen otherwise healthy subjects suffering from severe chronic periodontitis were enrolled in a 1 month pilot single-blind trial. Intensive periodontal treatment, consisting of full-mouth subgingival root debridement delivered within a 6-h period, was performed. Periodontal parameters were recorded before and 1 month after completion of treatment. Blood samples were taken at baseline and 1, 3, 5, 7 and 30 days after treatment. Interleukin-1 receptor antagonist (IL-1Ra), Interleukin-6 (IL-6) and C-reactive protein (CRP) serum concentrations were determined by enzyme-linked immunosorbent assay (ELISA). Complete blood counts were also performed. Results:, One day after treatment, mild neutrophilia and monocytosis (p < 0.05) and lymphopenia (p < 0.01) were accompanied by a sharp increase in inflammatory markers (IL-1Ra, IL-6, p < 0.01). A 10-fold increase in CRP (p < 0.001) was detected on day 1 and its kinetics followed a pattern of a classical acute phase response (significantly raised concentrations up to 1 week, p < 0.01). At 3,7 days after treatment, subjects presented also with a mild tendency towards a normocytic anaemic state (p < 0.01) and a degree of lympho-thrombocytosis (p < 0.05). The observed changes were similar to those expected following the well-characterized endotoxin-challenge model of inflammation. Conclusions:, Intensive periodontal treatment produced an acute systemic inflammatory response of 1 week duration and might represent an alternative to classic endotoxin-challenge or drug-induced models to study acute inflammation in humans. [source] A randomized, controlled, single-blind trial of teaching provided by a computer-based multimedia package versus lectureMEDICAL EDUCATION, Issue 9 2001Christopher Williams Background Computer-based teaching may allow effective teaching of important psychiatric knowledge and skills. Aims To investigate the effectiveness and acceptability of computer-based teaching. Method A single-blind, randomized, controlled study of 166 undergraduate medical students at the University of Leeds, involving an educational intervention of either a structured lecture or a computer-based teaching package (both of equal duration). Results There was no difference in knowledge between the groups at baseline or immediately after teaching. Both groups made significant gains in knowledge after teaching. Students who attended the lecture rated their subjective knowledge and skills at a statistically significantly higher level than students who had used the computers. Students who had used the computer package scored higher on an objective measure of assessment skills. Students did not perceive the computer package to be as useful as the traditional lecture format, despite finding it easy to use and recommending its use to other students. Conclusions Medical students rate themselves subjectively as learning less from computer-based as compared with lecture-based teaching. Objective measures suggest equivalence in knowledge acquisition and significantly greater skills acquisition for computer-based teaching. [source] Randomized, single-blind, trial of sertraline and buspirone for treatment of elderly patients with generalized anxiety disorderPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 2 2010Naghmeh Mokhber MD Aim:, Generalized anxiety disorder (GAD) in elderly people is common, but few systematic studies regarding the best treatments have been performed. The aim of the present study was to evaluate the efficacy and safety of sertraline and buspirone in the treatment of elderly patients with GAD. Methods:, Based on selection criteria, 46 patients were recruited who met DSM-IV criteria for GAD. Patients were randomly assigned to sertraline (50,100 mg/day) or buspirone (10,15 mg/day) for 8 weeks in a single-blind trial. The primary outcome measure used in the present study was the Hamilton Rating Scale for Anxiety (HRSA). Results:, Both sertraline and buspirone had significant anxiolytic efficacy. A steady decrease in the total HRSA scores for both groups was observed throughout the study period. After 2 and 4 weeks, buspirone was found to be significantly superior to sertraline (P < 0.001), but at the end of study period this difference did not reach statistical significance (P = 0.16). The mean HRSA score after 8 weeks significantly decreased in subjects treated with sertraline (P < 0.001), and buspirone (P < 0.001). No clinically adverse events or changes in laboratory test results were observed during the study period. Conclusion:, Both sertraline and buspirone appear to be efficacious and well tolerated in the treatment of GAD in elderly patients. Further studies with larger sample size, evaluating the effect of medical illness, cognitive impairment, depression, and combined therapy with support and psychotherapy are needed. [source] Randomized clinical trial comparing bipolar coagulating and standard great saphenous stripping for symptomatic varicose veinsBRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 4 2007D. Lorenz Background: Typical side-effects of saphenous stripping for symptomatic varicose veins include painful thigh haematomas, which a new bipolar coagulating electric vein stripper (EVS) may reduce. Methods: In a randomized, single-blind trial at three vascular centres, 99 patients were assigned to EVS and 101 to conventional stripping. The primary outcome was postoperative pain at rest and following physical exercise (climbing stairs). Haematomas were quantified by ultrasonography. Further endpoints were duration of postoperative compression, sick leave and quality of life (measured by the Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ) and Short Form 36 (SF-36®)). Results: Mean resting visual analogue scale for pain 24 h after surgery was 1·6 in the EVS group and 3·3 in the conventional stripping group (mean difference 1·7, 95 per cent confidence interval (c.i.) 1·4 to 1·9, P < 0·001). Mean ratings following exercise were 3·3 and 5·5 (mean difference 2·3, 95 per cent c.i. 2·0 to 2·6, P < 0·001) respectively. No patient in the EVS group had a measurable thigh haematoma, compared with 74 patients after conventional stripping (P < 0·001). The EVS significantly decreased the length of compression therapy and sick leave, and produced superior CIVIQ and SF-36 ratings. Conclusion: The EVS was safe and effective in avoiding painful haematomas following varicose vein surgery. Copyright © 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] | ||||||||||