Effects of continuous versus cyclical oral contraception: a randomized controlled trial

CONTEXT: Continuous oral contraception may better suppress the ovary and endometrium, lending itself to the treatment of other medical conditions. OBJECTIVE: Our objective was to determine the effects of continuous vs. cyclical oral contraception. DESIGN: This was a randomized double-blind trial. SETTING: This trial was performed at an academic medical center in Pennsylvania. PATIENTS: A total of 62 healthy women with regular menses were included in the study. INTERVENTION: Cyclical oral contraception (21-d active/7-d placebo given for six consecutive 28-d cycles) vs. continuous (168-d active pill) therapy using a monophasic pill (20 microg ethinyl estradiol and 1 mg norethindrone acetate) was examined. MAIN OUTCOME MEASURES: The primary outcome was vaginal bleeding, and secondary outcomes included hormonal, pelvic ultrasound, quality of life, and safety measures. RESULTS: There was no statistically significant difference in the number of total bleeding days between groups, but moderate/heavy bleeding was significantly greater with the cyclical regimen [mean 11.0 d (sd 8.5) vs. continuous 5.2 d (sd 6.8); P = 0.005], with both groups decreasing over time. Endogenous serum and urinary estrogens measured over six cycles were significantly lower (P = 0.02 and 0.04, respectively) in the continuous group than the cyclical group. Women in the continuous group also had a smaller ovarian volume and lead follicle size over the course of the trial by serial ultrasound examinations. The Moos Menstrual Distress Questionnaire showed that women on continuous therapy had less associated menstrual pain (P = 0.01) and favorable improvements in behavior (P = 0.04) during the premenstrual period. CONCLUSIONS: Continuous oral contraception does not result in a reduction of bleeding days over a 168-d period of observation but provides greater suppression of the ovary and endometrium. These effects are associated with improved patient symptomatology.     

Behavioural management of aggression in dementia: a randomized controlled trial

OBJECTIVE: To evaluate the efficacy of a brief behaviour management training programme for family carers of patients with dementia and aggressive behaviour. DESIGN: A randomized controlled trial of a four-session, community-based behaviour management programme. The primary outcome measure was the Rating Scale for Aggressive Behaviour in the Elderly. PARTICIPANTS: 62 patients with dementia, and their co-resident carers. RESULTS: There were no significant differences in aggression scores between behaviour management and control groups at follow-up. After adjusting for baseline differences in Rating Scale for Aggressive Behaviour in the Elderly scores, there was a trend towards a reduction in aggressive behaviour in the patients in the behaviour management group compared with those in the control group (F = 3.37, P = 0.071). CONCLUSIONS: This study adds to the small evidence base for the effectiveness of behavioural management strategies in dementia.     

Effects of resistance training and endurance training on insulin sensitivity in nonobese, young women: a controlled randomized trial

We examined the effects of a 6-month randomized program of endurance training (n = 14), resistance training (n = 17), or control conditions (n = 20) on insulin sensitivity in nonobese, younger women (18-35 yr). To examine the possible mechanism(s) related to alterations in insulin sensitivity, we measured body composition, regional adiposity, and skeletal muscle characteristics with computed tomography. We observed no changes in total body fat, sc abdominal adipose tissue, or visceral adipose tissue with endurance or resistance training. Insulin sensitivity, however, increased with endurance training (pre, 421 +/- 107; post, 490 +/- 133 mg/min; P < 0.05) and resistance training (pre, 382 +/- 87; post, 417 +/- 89 mg/min; P = 0.06). When the glucose disposal rate was expressed per kg fat-free mass (FFM), the improved insulin sensitivity persisted in endurance-trained (pre, 10.5 +/- 2.7; post, 12.1 +/- 3.3 mg/min x kg FFM; P < 0.05), but not in resistance-trained (pre, 9.7 +/- 1.9; post, 10.2 +/- 1.8 mg/min x kg FFM; P = NS) women. Muscle attenuation ratios increased (P < 0.05) in both endurance- and resistance-trained individuals, but this was not related to changes in insulin sensitivity. Moreover, the change in insulin sensitivity was not related to the increased maximum aerobic capacity in endurance-trained women (r = 0.24; P = NS). We suggest that both endurance and resistance training improve glucose disposal, although by different mechanisms, in young women. An increase in the amount of FFM from resistance training contributes to increased glucose disposal probably from a mass effect, without altering the intrinsic capacity of the muscle to respond to insulin. On the other hand, endurance training enhances glucose disposal independent of changes in FFM or maximum aerobic capacity, suggestive of an intrinsic change in the muscle to metabolize glucose. We conclude that enhanced glucose uptake after physical training in young women occurs with and without changes in FFM and body composition.     

Endurance exercise training in orthostatic intolerance: a randomized, controlled trial

Orthostatic intolerance is a syndrome characterized by chronic orthostatic symptoms of light-headedness, fatigue, nausea, orthostatic tachycardia, and aggravated norepinephrine levels while standing. The aim of this study was to assess the protective effect of exercise endurance training on orthostatic symptoms and to examine its usefulness in the treatment of orthostatic intolerance. 2768 military recruits were screened for orthostatic intolerance by questionnaire. Tilt-table testing identified 36 cases of orthostatic intolerance out of the 2768 soldiers. Subsequently, 31 of these subjects with orthostatic intolerance entered a randomized, controlled trial. The patients were allocated randomly to either a "training" (3 months jogging) or a "control" group. The influence of exercise training on orthostatic intolerance was assessed by determination of questionnaire scores and tilt-table testing before and after intervention. After training, only 6 individuals of 16 still had orthostatic intolerance compared with 10 of 11 in the control group. The Fisher exact test showed a highly significant difference in diagnosis between the 2 groups (P=0.008) at the end of the study. Analysis of the questionnaire-score showed significant interaction between time and group (P=0.001). The trained subjects showed an improvement in the average symptom score from 1.79+/-0.4 to 1.04+/-0.4, whereas the control subjects showed no significant change in average symptom score (2.09+/-0.6 and 2.14+/-0.5, respectively). Our data demonstrate that endurance exercise training leads to an improvement of symptoms in the majority of patients with orthostatic intolerance. Therefore, we suggest that endurance training should be considered in the treatment of orthostatic intolerance patients.     

Clinical hypertension research tools: the randomized controlled clinical trial

The randomized clinical trial is used in hypertension research as a primary mode for evaluating new, promising therapies. Herein, the authors provide an overview of design features of clinical trials, particularly those useful for designing a hypertension therapeutic clinical trial.     

Reducing clinical inertia in hypertension treatment: a pragmatic randomized controlled trial

Clinical inertia is a major contributor to poor blood pressure (BP) control. The authors tested the effectiveness of an intervention targeting physician, patient, and office system factors with regard to outcomes of clinical inertia and BP control. A total of 591 adult primary care patients with elevated BP (mean systolic BP ≥ 140 mm Hg or mean diastolic BP ≥ 90 mm Hg) were randomized to intervention or usual care. An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused primary care clinic visits, and furnished providers with treatment decision support. The intervention reduced clinical inertia (-29% vs -11%, P=.001). Nonetheless, change in BP did not differ between intervention and usual care (-10.1/-4.1 mm Hg vs -9.1/-4.5 mm Hg, P=.50 and 0.71 for systolic and diastolic BP, respectively). Future primary care-focused interventions might benefit from the use of specific medication titration protocols, treatment adherence support, and more sustained patient follow-up visits.     

Individualized stress management for primary hypertension: a randomized trial

OBJECTIVE: To test the efficacy of individualized stress management for primary hypertension in a randomized clinical trial with the use of ambulatory blood pressure (BP) measures. METHODS: Men and women aged 28 to 75 years with mean ambulatory BP greater than 140/90 mm Hg received 10 hours of individualized stress management by means of semistandardized treatment components. They were randomly assigned to immediate treatment (n = 27) or a wait list control group (n = 33). Participants on the wait list were subsequently offered treatment. Six-month follow-up data were available from 36 of the 45 participants who completed treatment. Measures were 24-hour ambulatory BP, lipid levels, weight, and psychological measures. RESULTS: Blood pressure was significantly reduced in the immediate treatment group and did not change in control subjects (-6.1 vs +0.9 mm Hg for systolic and -4.3 vs +0.0 mm Hg for diastolic pressure). When the wait list control group was later treated, BP was similarly reduced by -7.8 and -5.2 mm Hg, and for the combined sample, total change at follow-up was -10.8 and -8.5 mm Hg. Level of BP at the beginning of treatment was correlated with BP change (r = 0.45 [P<.001] and 0.51 [P<.001], respectively), and amount of systolic BP change was positively correlated with reduction in psychological stress (r = 0.34) and change in anger coping styles (r = 0.35-0.41). CONCLUSIONS: Individualized stress management is associated with ambulatory BP reduction. The effects were replicated and further improved by follow-up. Reductions in psychological stress and improved anger coping appear to mediate the reductions in BP change.     

Effects of exercise training on home blood pressure values in older adults: a randomized controlled trial

OBJECTIVE: To determine the effects of exercise training on the blood pressure (BP) values of older adults, using home blood pressure measurement. DESIGN: Randomized controlled trial. PARTICIPANTS: A total of thirty-nine free-living older adults (including 19 men) aged from 60-81 years with home systolic blood pressure > 120 mmHg and without significant cardiopulmonary-musculoskeletal disease, were randomly allocated to either 25 weeks of exercise training (exercise group) or to a control program (control group). MAIN OUTCOME MEASUREMENTS: Change in the 2-week averages of home systolic and diastolic blood pressure values measured with a validated automatic device before, during and after the intervention period. RESULTS: Compared with the control group, the exercise group showed a significant decrease in values for home systolic blood pressure (maximum between-group difference = 7.7 mmHg, P = 0.003) and home diastolic blood pressure (4.2 mmHg, P = 0.001). These changes were observed for both genders. CONCLUSIONS: Exercise training was effective for older adults in lowering home blood pressure values. This is the first trial to demonstrate the usefulness of home blood pressure measurement in examining the effect of exercise training on blood pressure values.     

Effects of a short-term interval aerobic training program with recovery bouts on vascular function in sedentary aged 70 or over: A randomized controlled trial

Background: Interval aerobic training programs with active recovery bouts (IATP-R) are reported as being more adapted to seniors while improving cardiorespiratory and endurance parameters. Report of benefits on vascular function is still limited.Purpose: To measure the impact of IATP-R on vascular function among seniors.Methods: Sedentary volunteers (≥70 years of age) were randomly assigned to either IATP-R (n = 30) or control group (n = 30). The IATP-R consisted of 2 weekly sessions of 30-min (6 × 4-min at first ventilatory threshold (VT₁) intensity + 1-min at 40% of VT₁) cycling exercise over 9.5-week. Controls remained their sedentary life over the same period. In all participants, the endothelial function was measured by flow-mediated dilation (FMD) in brachial artery and arterial stiffness through the carotid/radial and carotid/femoral pulse wave velocity (PWV). Systolic (SBP) and diastolic blood pressure (DBP) were measured at baseline and 9.5 weeks later.Results: Resulting from a planned interim analysis, IATP-R improved SBP (IATP-R: from 133.7 ± 9.8 to 122.6 ± 9.4 mmHg vs. Controls: from 128.9 ± 12.5 to 132.6 ± 14.7 mmHg), DBP (IATP-R: from 80.2 ± 7.0 to 74.1 ± 6.7 mmHg vs. Controls: from 77.1 ± 6.8 to 80.3 ± 7.5 mmHg), and FMD (IATP-R: from 6.7 ± 2.0 to 7.5 ± 2.7% vs. Controls: from 7.9 ± 2.7 to 7.5 ± 2.5%). No significant impact on PWV was measured.Conclusion: Although these findings resulted from an interim analysis, IATP-R might be effective in regulating BP and improving endothelial function among sedentary seniors.     

Cognitive training is ineffective in hypoxemic COPD: a six-month randomized controlled trial

Cognitive impairment is highly prevalent in chronic obstructive pulmonary disease (COPD) complicated by chronic hypoxemia, but the effect of cognitive training in patients with COPD has not been studied. The aim of the present study was to verify whether cognitive training can preserve cognitive abilities of patients with hypoxemic COPD. Our series consisted of 105 COPD patients with at rest (n = 36) or effort (n = 69) hypoxemia and free from concurrent dementing diseases. Neuropsychologic assessment included a screening test, the Mini Mental State Examination (MMSE), and a standardized confirmatory battery of neuropsychological tests, the Mental Deterioration Battery (MDB). After baseline assessment, patients were randomized to receive standardized multidimensional care (standardization of pharmacological therapy, health education, selection of inhalers according to patient's ability, respiratory rehabilitation, nutritional counseling, oxygen therapy, and control visits) with (n = 53) or without (n = 52) cognitive training aimed at stimulating attention, learning, and logical-deductive thinking. Cognitive performance was reassessed after 1.5, 4, and 6 months. The analysis of variance for repeated measures (ANOVA) having the group membership (study vs. control) as grouping factor was used to assess changes in cognitive performance. Both intervention and control groups showed no significant changes in cognitive performance except for a trend toward improvement in verbal fluency and verbal memory, but cognitive intervention had no significant effect. In conclusion, cognitive training seems ineffective in COPD. However, a multidimensional standardized therapeutic approach, as it was indistinctly provided to all patients, could help to slow or prevent cognitive decline.     

Effects of exercise training on frailty in community-dwelling older adults: results of a randomized,controlled trial

OBJECTIVES: Although deficits in skeletal muscle strength, gait, balance, and oxygen uptake are potentially reversible causes of frailty, the efficacy of exercise in reversing frailty in community-dwelling older adults has not been proven. The aim of this study was to determine the effects of intensive exercise training (ET) on measures of physical frailty in older community-dwelling men and women. DESIGN: Randomized controlled trial. SETTING: Medical school research center. PARTICIPANTS: One hundred fifteen sedentary men and women (mean age +/- standard deviation = 83 +/- 4) with mild to moderate physical frailty, as defined by two of the following three criteria: Modified Physical Performance Test (modified PPT) score between 18 and 32, peak oxygen uptake (VO2 peak) between 10 and 18 mL/kg/min, and self-report of difficulty or assistance with one basic activity of daily living (ADL), or two instrumental ADLs. INTERVENTION: Participants were randomly assigned to a control group that performed a 9-month low-intensity home exercise program (control) or an exercise-training program (ET). The control intervention primarily consisted of flexibility exercises. ET began with 3 months of flexibility, light-resistance, and balance training. During the next 3 months, resistance training was added, and, during the next 3 months, endurance training was added. MEASUREMENTS: Modified PPT score, VO2 peak, performance of ADLs as measured by the Older Americans Resources and Services instrument, and the Functional Status Questionnaire (FSQ). RESULTS: ET resulted in significantly greater improvements than home exercise in three of the four primary outcome measures. Adjusted 95% confidence bounds on the magnitude of improvement in the ET group compared with the control group were 1.0 to 5.2 points for the modified PPT score, 0.9 to 3.6 mL/kg/min for VO2 peak, and 1.6 to 4.9 points for the FSQ score. CONCLUSIONS: Our results show that intensive ET can improve measures of physical function and preclinical disability in older adults who have impairments in physical performance and oxygen uptake and are not taking hormone replacement therapy better than a low-intensity home exercise program.     

内镜模拟训练在上消化道内镜培训中的作用研究

目的 探讨内镜模拟训练在上消化道内镜教学中的作用.方法 2005年1月-2007年3月41名无内镜操作经验的进修医师、研究生、住院医师,随机分为两组.非内镜模拟训练组于内镜中心观摩学习1个月后开始操作内镜,内镜模拟训练组于观摩学习的同时接受10 h的内镜模拟训练.由专人对所有受训者最初20例内镜操作进行评价、记录,包括插入食管是否成功、胃内观察是否成功、通过幽门是否成功、进入降段是否成功、总的操作时间.结果 插入食管成功率、进入降段成功率两组间差异无统计学意义;胃内观察成功率(P<0.001)、通过幽门成功率(P<0.001)、总操作时间(P=0.032),内镜模拟训练组均优于非内镜模拟训练组,两组间差异有统计学意义.结论 内镜模拟训练在上消化道内镜教学中有重要作用,有助于受训者迅速掌握内镜操作方法,缩短教学时间,减少患者痛苦.     

Effects of endurance and resistance training on total daily energy expenditure in young women: a controlled randomized trial

There exists considerable controversy regarding the impact of different modes of exercise training on total daily energy expenditure (TEE). To examine this question, young, nonobese women were randomly assigned to a supervised 6-month program of endurance training, resistance training, or control condition. TEE was measured before and 10 d after a 6-month exercise program was completed with doubly labeled water. Body composition was determined from dual energy x-ray absorptiometry, maximum aerobic capacity from a treadmill test to exhaustion, and muscular strength from one-repetition maximum tests. Results showed that body composition did not change in endurance-trained women, but maximum aerobic capacity increased by 18%. Resistance-trained women increased muscular strength and fat-free mass (1.3 kg). TEE did not significantly change when measured subsequent to the endurance or resistance training programs. Absolute resting metabolic rate increased in resistance-trained women but not when adjusted for fat-free mass. No change in physical activity energy expenditure was found in any of the groups. These results suggest that endurance and resistance training does not chronically alter TEE in free-living young women. Thus, the energy-enhancing benefits of exercise training are primarily derived from the direct energy cost of exercise and not from a chronic elevation in daily energy expenditure in young, nonobese women.     

Effectiveness of sensorimotor training in patients with rheumatoid arthritis: a randomized controlled trial

The objective of this study was to evaluate the effectiveness of a sensorimotor training in patients with rheumatoid arthritis on the improvement of functional skills and quality of life, a double-blinded, prospective, randomized controlled trial. One hundred two participants with rheumatoid arthritis were selected. After the baseline evaluation, the participants were randomized to two different groups: sensorimotor group (2 sessions per week, 30–50 min each session, besides continuing taking the same drugs as the control group) and control group (control group was only submitted to the clinical drug treatment with Methotrexate, Leflunomide and/or Prednisone (5 mg), being then evaluated 4 months later). Functional capacity [Health Assessment Questionnaire (HAQ) and Timed Up & Go Test (TU&GT)], Balance and Gait (Berg Balance Scale (BBS) and Tinetti Test) and Quality of Life (Short Form Health Survey—SF-36). The study had been concluded with ninety-one participants, and a statistically significant improvement was found in all variables assessed: HAQ (P < .01), TU&GT (P < .01), BBS (P < .01), Tinetti Test (P < .01) and improvement in the subscales of SF-36 (P < .01) in the sensorimotor group in comparison with the baseline evaluation and control group. No significant difference was found related to the pre- and post-evaluation in the control group. Therefore, the sensorimotor training is effective in the improvement of the functional capacity and quality of life of patients with rheumatoid arthritis.     

Effects of functional movement screen training in high-school baseball players: A randomized controlled clinical trial

Background:In recent years, the functional movement screen (FMS) and FMS training have attracted attention as a means of preventing injury, but no studies have examined the effect of such training in high-school baseball players. The aim of this study was to clarify the effect of FMS training on FMS score, physical function and baseball performance in high-school baseball players.Methods:Subjects in this randomized controlled clinical trial were high-school male baseball players assigned to either an FMS training group (intervention group) or a control group. The intervention group performed FMS training 4 times per week for 12 weeks. FMS ability, physical function, and baseball performance were measured prior to the intervention, 8, 12, and 24 weeks after the intervention in the subjects’ school environment.Results:A total of 71 baseball players aged 15 to 17 years were recruited and assigned to either an intervention group (n = 37) or control group (n = 34). There was no significant difference in the characteristics of participants between the 2 groups. Most FMS scores improved to 12 weeks after continued training. In the intervention group compared with the control group, deep squat, hurdle step, inline lunge, active straight leg raise, trunk stability push-up and rotary stability FMS score, total FMS score and eyes closed single leg stance time significantly increased after 8 weeks of training. While hurdle step, inline lunge, active straight leg raise, trunk stability push-up, total FMS score, and eyes closed single leg stance time significantly increased, pitching ball speed significantly decreased at the end of the 12 week training period. Eyes closed single leg stance time and feeling of fatigue significantly improved 12 weeks after training. The number of subjects who scored less than 14 for the total FMS score in the intervention group compared with control group were significantly less after 8 and 12 weeks of FMS training.Conclusion:FMS training for 8 weeks contributes to improving FMS scores for high-school baseball players, but FMS scores go down if FMS training is not continued.Trial registration:University Hospital Medical Information Network Center, Tokyo, Japan: UMIN000027553. Registered on May 30, 2017.