Effects of Active Learning Education on Arterial Stiffness of Older Adults with Low Health Literacy: A Randomized Controlled Trial

Aim: We examined the effects of active learning education on arterial stiffness and physical activity of community-dwelling older adults with low health literacy. Methods: This study is a secondary analysis of randomized controlled trial of 60 participants aged 65 and older with low health literacy. The intervention group ( n =30) participated in a weekly 90-minute active learning program session for 24 weeks, which addressed health promotion in older age. The control group ( n =30) attended a 90-minute health education class in a didactic manner. The outcomes were measured at baseline and in week 24. The degree of arterial stiffness was assessed based on the cardio-ankle vascular index (CAVI) using the VS-1500 device (Fukuda Denshi Co., Ltd., Tokyo, Japan). The shortened version of the self-reported International Physical Activity Questionnaire was used to assess the amount of total physical activity determined by the metabolic equivalent hours per week. We used analysis by intention-to-treat, with multiple imputation for missing data. Results: Seven participants (11.7%) dropped out prior to the post-intervention assessment. The multiple imputation analysis revealed that the intervention group showed significant improvement in CAVI [between-groups difference (95% confidence interval)=-0.78 (-1.25 to -0.31), Cohen’s d =0.82] and physical activity [32.5 (0.3 to 64.7), Cohen’s d =0.57] as compared with the control group. The sensitivity analysis for the complete cases showed similar results. Conclusion: Active learning health education may be effective in improving arterial stiffness and physical activity in older adults with low health literacy.     

Randomized Trial of Plaque-Identifying Toothpaste: Decreasing Plaque and Inflammation

Background

Randomized data are sparse about whether a plaque-identifying toothpaste reduces dental plaque and nonexistent for inflammation. Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for cardiovascular disease. The hypotheses that Plaque HD (TJA Health LLC, Joliet, Ill), a plaque-identifying toothpaste, produces statistically significant reductions in dental plaque and hs-CRP were tested in this randomized trial.

Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial

BackgroundWorld Health Organization (WHO) group 1 pulmonary arterial hypertension (PAH) is a progressive, debilitating disease. Previous observational studies have demonstrated that pulmonary artery denervation (PADN) reduces pulmonary artery pressures in PAH. However, the safety and effectiveness of PADN have not been established in a randomized trial.ObjectivesThe aim of this study was to determine the treatment effects of PADN in patients with group 1 PAH.MethodsPatients with WHO group 1 PAH not taking PAH-specific drugs for at least 30 days were enrolled in a multicenter, sham-controlled, single-blind, randomized trial. Patients were assigned to receive PADN plus a phosphodiesterase-5 inhibitor or a sham procedure plus a phosphodiesterase-5 inhibitor. The primary endpoint was the between-group difference in the change in 6-minute walk distance from baseline to 6 months.ResultsAmong 128 randomized patients, those treated with PADN compared with sham had a greater improvement in 6-minute walk distance from baseline to 6 months (mean adjusted between-group difference 33.8 m; 95% CI: 16.7-50.9 m; P < 0.001). From baseline to 6 months, pulmonary vascular resistance was reduced by ?3.0 ± 0.3 WU after PADN and ?1.9 ± 0.3 WU after sham (adjusted difference ?1.4; 95% CI: ?2.6 to ?0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation, and decreased N-terminal pro–brain natriuretic peptide. Clinical worsening was less (1.6% vs 13.8%; OR: 0.11; 95% CI: 0.01-0.87), and a satisfactory clinical response was greater (57.1% vs 32.3%; OR: 2.79; 95% CI: 1.37-5.82) with PADN treatment during 6-month follow-up.ConclusionsIn patients with WHO group 1 PAH, PADN improved exercise capacity, hemodynamic status, and clinical outcomes during 6-month follow-up. (Safety and Efficacy of Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension [PADN-CFDA]; NCT03282266)     

Effects of Pulmonary Rehabilitation on Systemic Inflammation and Exercise Capacity in Bronchiectasis: A Randomized Controlled Trial

Introduction

Bronchiectasis is a chronic condition that is becoming a global health concern.

Objective

To examine the effects of pulmonary rehabilitation (PR) on systemic inflammation, exercise capacity, and quality of life in participants with bronchiectasis.

Methods

Participants were randomized to receive PR (outpatient, three weekly sessions for 3 months) or control intervention (usual care?+?airway clearance therapy?+?breathing exercises). Data on laboratory (fibrinogen level) and patient-centered outcomes such as physical fitness [6-min walk test (6MWT)] and quality of life were collected.

Results

A total of 41 participants were evaluated (20 in the intervention group and 21 in the control group). The magnitude of change between baseline and the end of study was greater in the PR group than in the control group—the 6MWT distance increased by a mean of 54 m (54 vs 12 m; p?<?0.01), fibrinogen showed a significant reduction (fibrinogen ? 92.8 versus ? 47.1 mg/dl; p?<?0.01), and quality of life improved according to Saint George’s Respiratory Questionnaire (SGRQ) (? 7.5 vs 3.2; p?<?0.01), which exceeded the minimal clinically important difference of 4 points.

Conclusion

PR effectively improved physical fitness, quality of life, and the degree of systemic inflammation, as reflected by changes in 6 MWT, fibrinogen levels and SGRQ scores. This study supports the inclusion of people with bronchiectasis in supervised PR programs.

     

Effect of Spironolactone in Resistant Arterial Hypertension: A Randomized,Double-Blind,Placebo-Controlled Trial (ASPIRANT-EXT)

This study was designed to assess the effect of the addition of low-dose spironolactone on blood pressure (BP) in patients with resistant arterial hypertension.Patients with office systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg despite treatment with at least 3 antihypertensive drugs, including a diuretic, were enrolled in this double-blind, placebo-controlled, multicentre trial. One hundred sixty-one patients in outpatient internal medicine departments of 6 hospitals in the Czech Republic were randomly assigned to receive 25 mg of spironolactone (N = 81) or a placebo (N = 80) once daily as an add-on to their antihypertensive medication, using simple randomization. This study was registered with ClinicalTrials.gov, number {"type":"clinical-trial","attrs":{"text":"NCT00524615","term_id":"NCT00524615"}}NCT00524615.Analyses were done with 150 patients who finished the follow-up (74 in the spironolactone and 76 in the placebo group). At 8 weeks, BP values were decreased more by spironolactone, with differences in mean fall of SBP of −9.8, −13.0, −10.5, and −9.9 mm Hg (P < 0.001 for all) in daytime, nighttime, and 24-hour ambulatory BP monitoring and in the office. The respective DBP differences were −3.2, −6.4, −3.5, and −3.0 mm Hg (P = 0.013, P < 0.001, P = 0.005, and P = 0.003). Adverse events in both groups were comparable. The office SBP goal <140 mm Hg at 8 weeks was reached in 73% of patients using spironolactone and 41% using placebo (P = 0.001).Spironolactone in patients with resistant arterial hypertension leads to a significant decrease of both SBP and DBP and markedly improves BP control.     

Effect of Perineal Self-Acupressure on Constipation: A Randomized Controlled Trial

BACKGROUNDThe efficacy of perineal self-acupressure in treating constipation is uncertain.OBJECTIVEWe aimed to evaluate whether perineal self-acupressure would improve patient reports of quality of life and bowel function at 4 weeks after training.DESIGNA randomized, parallel group trial was conducted.SETTINGThe study took place at the UCLA Department of Medicine.PATIENTSOne hundred adult patients who met Rome III criteria for functional constipation participated.INTERVENTIONThe control group received information about standard constipation treatment options, while the treatment group received training in perineal self-acupressure plus standard treatment options.MEASUREMENTSPrimary outcome was the Patient Assessment of Constipation Quality of Life (PAC-QOL). Secondary outcomes included patient assessments of bowel function (as measured by a modified Bowel Function Index (BFI)), and health and well-being (as measured by the SF-12v2).RESULTSThe mean PAC-QOL was improved by 0.76 in the treatment group and by 0.17 in the control group (treatment-effect difference, 0.59 [95 % CI, 0.37 to 0.81]; p < 0.01). The mean modified BFI was improved by 18.1 in the treatment group and by 4.2 in the control group (treatment-effect difference, 13.8 [95 % CI, 5.1 to 22.5]; p < 0.01). The mean SF-12v2 Physical Component Score was improved by 2.69 in the treatment group and reduced by 0.36 in the control group (treatment-effect difference, 3.05, [95 % CI, 0.85 to 5.25]; p < 0.01); and the mean SF-12v2 Mental Component Score was improved by 3.12 in the treatment group and improved by 0.30 in the control group (treatment-effect difference, 2.82, [95 % CI, −0.10 to 5.74]; p < 0.07).LIMITATIONThe trial was not blinded.CONCLUSIONAmong patients with constipation, perineal self-acupressure improves self-reported assessments of quality of life, bowel function, and health and well-being relative to providing standard constipation treatment options alone.

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-014-3084-6) contains supplementary material, which is available to authorized users.KEY WORDS: perineum, constipation, acupressure     

Aerobic Training Effect on Arterial Stiffness in Metabolic Syndrome

Background

Metabolic syndrome, physical inactivity, and central obesity contribute to early vascular aging, which leads to increased risk of cardiovascular disease. This study aimed to assess the effect of heart rate (HR)-targeted aerobic exercise training on the indices of early vascular aging, in particular, arterial stiffness, and on anthropometric and clinical profile of metabolic syndrome subjects.

The Effect of Low‐Dose Carvedilol,Nebivolol, and Metoprolol on Central Arterial Pressure and Its Determinants: A Randomized Clinical Trial

In this prospective, open‐label, randomized, controlled clinical trial the effects of low‐dose carvedilol, nebivolol, and metoprolol on central arterial pressure and augmentation index (AIx) and its heart rate–corrected value (AIx@75) were assessed. The authors randomized 75 hypertensive patients (18–70 years) to carvedilol 12.5/25 mg, metoprolol 50/100 mg, or nebivolol 2.5/5 mg daily and followed them up for 3 months. Central arterial pressure and AIx were measured with applanation tonometry at baseline and at the end of follow‐up. Analyses were restricted to 60 completers. Central systolic pressure decreased equally in all 3 treatment arms. AIx remained unchanged, while AIx@75 decreased significantly by 5.4%±2.5% in the nebivolol group. According to general linear models, individual change in heart rate was a strong predictor of change in AIx in the carvedilol group (r²=0.23, P=.03) although no similar association was found in the nebivolol group (r²=0.09). The impact of β‐blockers with vasodilator effects on pressure augmentation seems to be different with nebivolol having the largest potential of decreasing AIx@75. While AIx changes associated with carvedilol treatment are strongly driven by heart rate changes, those associated with nebivolol treatment seem to be the result of other mechanisms.     

Longitudinal Associations between Alcohol Intake and Arterial Stiffness,Pressure Wave Reflection,and Inflammation

Aims: This prospective observational study, which utilized repeated annual measurements performed over a 9-year period, applied mixed model analyses to examine age-related differences in longitudinal associations between alcohol intake and arterial stiffness, pressure wave reflection, and inflammation. Methods: In 4016 middle-aged (43±9 years) healthy Japanese male employees, alcohol intake, brachial-ankle pulse wave velocity (baPWV), radial augmentation index (rAI), and serum C-reactive protein (CRP) levels were measured annually during a 9-year study period. Results: The estimated marginal mean baPWV (non-drinkers=1306 cm/s, mild–moderate drinkers=1311 cm/s, and heavy drinkers=1337 cm/s,P＜0.01) and that of rAI showed significant stepped increases in an alcohol dose-dependent manner in the entire cohort, but an increase in rAI was not observed in subjects aged ≥ 50 years. The estimated slope of the annual increase in baPWV, but not rAI, was higher for heavy drinkers than for non-drinkers (slope difference, 1.84;P＜0.05), especially for subjects aged ＜50 years (slope difference, 2.84;P＜0.05). Conclusion: In middle-aged male Japanese employees, alcohol intake may attenuate inflammatory activity. While alcohol intake may exacerbate the progression of arterial stiffening in a dose-dependent manner without mediating inflammation, especially in subjects under 50 years of age, it may promote pressure wave reflection abnormalities with aging at earlier ages without further exacerbation at older ages.     

Arterial Stiffness in Prehypertension: A Possible Vicious Cycle

The pathophysiological abnormalities associated with increased arterial stiffness and/or abnormal pressure wave reflection may play crucial roles in increasing the risk of development of cardiovascular events. On the other hand, prehypertension, defined as a systolic blood pressure of 120–139 and/or a diastolic blood pressure of 80–89 mmHg, is a “danger zone” for the later development of hypertension and is also associated with an increased incidence of cardiovascular diseases and cardiovascular mortality. We discuss the association among arterial stiffness/pressure wave reflection, prehypertension, and the later development of hypertension. Several prospective studies have demonstrated that increased arterial stiffness/abnormal pressure wave reflection are risk factors for the later development of hypertension in subjects with prehypertension. On the contrary, persistence of prehypertention accelerates the age-related increase of the arterial stiffness. Thus, arterial stiffness and prehypertension may be elements of a vicious cycle, and other cardiovascular risk factors, such as aging and abnormal glucose metabolism, may aggravate this cycle. In the future, development of a simple technique to assess large/small arterial stiffness and an effective strategy to reduce arterial stiffness in subjects with prehypertension is warranted.     

不同类型肥胖对原发性高血压患者动脉僵硬度的影响

目的 探讨不同类型肥胖对原发性高血压患者动脉僵硬度的影响.方法 选择原发性高血压患者776例,根据体质指数(BMI)和腰围将受试者分为4组:正常BMI+正常腰围组(正常组,n=194)、正常BMI+腰围增高组(单纯腰围增高组,n=195)、BMI增高+正常腰围组(单纯BMI增高组,n=196)及BMI增高+腰围增高组(BMI和腰围增高组,n=191).测定所有受试者肱踝脉搏波传导速度和踝臂指数;根据受试者的血脂情况,计算动脉硬化指数.结果 BMI和腰围增高组受试者的肱踝脉搏波传导速度(2120±263 mm/s)和动脉硬化指数(3.35±0.87)明显高于正常组(P＜0.01)及单纯腰围增高组和单纯BMI增高组(P＜0.05).BMI和腰围增高组受试者的踝臂指数(0.72±0.15)明显低于正常组(P＜0.01)及单纯腰围增高组和单纯BMI增高组(P＜0.05).单纯BMI增高组受试者的踝臂指数及动脉硬化指数与单纯腰围增高组无统计学差异(P＞0.05).析因分析结果显示,BMI和腰围增高对动脉僵硬度的影响均显著,且二者存在协同效应.结论 腹型肥胖的原发性高血压患者动脉弹性受损程度严重,BMI和腰围增高对动脉弹性功能受损有交互协同作用.     

基于动脉硬化检测仪测定的动脉硬化与红细胞参数的相关性

目的研究体检人群动脉硬化与红细胞参数的关系。方法选择2014年7月在中国中医科学院广安门医院南区的体检者304人,询问病史、测量身高、体重、血压等,检测血常规、血生物化学等指标,应用欧姆龙BP-203 RPEⅢ动脉硬化检测仪检测体检人群的动脉弹性,根据臂踝脉搏波传导速度(ba PWV)分为动脉正常组(n=117)、轻度硬化组(n=112)和硬化组(n=75),将三组之间的红细胞参数,包括红细胞(RBC)、血红蛋白(HGB)、红细胞压积(HCT)、平均红细胞体积(MCV)、平均红细胞血红蛋白量(MCH)、平均红细胞血红蛋白浓度(MCHC)、红细胞分布宽度变异系数(RDW-CV)、红细胞分布宽度标准差(RDW-SD)进行比较分析。结果硬化组MCV、RDWCV明显高于动脉正常组(P0.05或P0.01);硬化组RDW-SD高于轻度硬化组(P0.05),轻度硬化组RDWSD高于动脉正常组(P0.05)。相关性分析显示,HGB、HCT、MCV、MCH、RDW-CV、RDW-SD与ba PWV呈正相关。应用多元线性逐步回归分析,最终纳入回归方程的指标是RDW-SD、HGB,回归方程为ba PWV=-898.411+39.657×RDW-SD+3.171×HGB。结论 RDW-SD对评价动脉硬化的程度具有一定的临床参考意义,同时HGB是动脉硬化的影响因子。     

Resistant Hypertension Optimal Treatment Trial: A Randomized Controlled Trial

The prevalence of resistant hypertension (ReHy) is not well established. Furthermore, diuretics, angiotensin‐converting enzyme inhibitors or angiotensin‐receptor blockers, and calcium channel blockers are largely used as the first 3‐drug combinations for treating ReHy. However, the fourth drug to be added to the triple regimen is still controversial and guided by empirical choices. We sought (1) to determine the prevalence of ReHy in patients with stage II hypertension; (2) to compare the effects of spironolactone vs clonidine, when added to the triple regimen; and (3) to evaluate the role of measuring sympathetic and renin‐angiotensin‐aldosterone activities in predicting blood pressure response to spironolactone or clonidine. The Resistant Hypertension Optimal Treatment (ReHOT) study ( ClinicalTrials.gov NCT01643434) is a prospective, multicenter, randomized trial comprising 26 sites in Brazil. In step 1, 2000 patients will be treated according to hypertension guidelines for 12 weeks, to detect the prevalence of ReHy. Medical therapy adherence will be checked by pill count monitoring. In step 2, patients with confirmed ReHy will be randomized to an open label 3‐month treatment with spironolactone (titrating dose, 12.5–50 mg once daily) or clonidine (titrating dose, 0.1–0.3 mg twice daily). The primary endpoint is the effective control of blood pressure after a 12‐week randomized period of treatment. The ReHOT study will disseminate results about the prevalence of ReHy in stage II hypertension and the comparison of spironolactone vs clonidine for blood pressure control in patients with ReHy under 3‐drug standard regimen.     

The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial

Background The aim of the study is to evaluate the effect of virtual reality application during a colonoscopy on the pain and anxiety experienced by patients.Methods The study was conducted as experimental, randomized, controlled research. The study was carried out between October 15, 2017 and May 20, 2018 in the Endoscopy Unit of a Public Hospital in northern Turkey. The study sample consisted of 60 patients who underwent colonoscopy. The patients were divided into 2 groups by using simple randomization. The patients in the experimental group watched virtual reality applications during colonoscopy, whereas the patients in the control group underwent standard colonoscopy protocol. Colonoscopy was performed on patients in both groups by the same gastroenterologist without the use of anesthesia. The demographic data of both groups, pain levels during and after the procedure, before and after the procedure anxiety levels were evaluated.Results The mean age of the patients in the experimental group was 56.33 ± 11.81, the mean age of the patients in the control group was 56.20 ± 15.62. There was no statistically significant difference between the pre- and post-operative state anxiety score averages of the patients in the experimental and control groups. There was a statistically significant difference between the trait anxiety scores (P < .000) and pain scores (P < .03) during the procedure between both groups.Conclusion The virtual reality application was found to reduce patients’ pain during the colonoscopy procedure. The virtual reality application, an easily available, inexpensive, and non-invasive method, can be used by nurses in pain management during colonoscopy.