Online mindfulness as a promising method to improve exercise capacity in heart disease: 12-month follow-up of a randomized controlled trial.

There is increasing evidence that mindfulness can reduce stress, and thereby affect other psychological and physiological outcomes as well. Earlier, we reported the direct 3-month results of an online modified mindfulness-based stress reduction training in patients with heart disease, and now we evaluate the effect at 12-month follow-up. 324 patients (mean age 43.2 years, 53.7% male) were randomized in a 2:1 ratio to additional 3-month online mindfulness training or to usual care alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were blood pressure, heart rate, respiratory rate, NT-proBNP, cortisol levels (scalp hair sample), mental and physical functioning (SF-36), anxiety and depression (HADS), perceived stress (PSS), and social support (PSSS12). Differences between groups on the repeated outcome measures were analyzed with linear mixed models. At 12-months follow-up, participants showed a trend significant improvement exercise capacity (6MWT: 17.9 meters, p = 0.055) compared to UC. Cohen's D showed significant but small improvement on exercise capacity (d = 0.22; 95%CI 0.05 to 0.39), systolic blood pressure (d = 0.19; 95%CI 0.03 to 0.36), mental functioning (d = 0.22; 95%CI 0.05 to 0.38) and depressive symptomatology (d = 0.18; 95%CI 0.02 to 0.35). All other outcome measures did not change statistically significantly. In the as-treated analysis, systolic blood pressure decreased significantly with 5.5 mmHg (p = 0.045; d = 0.23 (95%CI 0.05-0.41)). Online mindfulness training shows favorable albeit small long-term effects on exercise capacity, systolic blood pressure, mental functioning, and depressive symptomatology in patients with heart disease and might therefore be a beneficial addition to current clinical care. TRIAL REGISTRATION: www.trialregister.nl NTR3453.

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial.

BACKGROUND: Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease. METHODS: The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male) with heart disease in a 2:1 ratio (n = 215 versus n = 109) to a 12-week online mindfulness training in addition to usual care (UC) compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP), subjective health status (SF-36), perceived stress (PSS), psychological well-being (HADS), social support (PSSS12) and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention). Linear mixed models were used to evaluate differences between groups on the repeated outcome measures. RESULTS: Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050). There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033). No significant differences were seen on other outcomes. CONCLUSIONS: Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease. TRIAL REGISTRATION: Dutch Trial Register 3453.

Randomized study designs for lifestyle interventions: a tutorial.

Unhealthy lifestyle behaviours are considered modifiable risk factors for many diseases. Lifestyle interventions that target these behaviours need rigorous evaluation to assess their effectiveness. The randomized controlled trial is the study design of choice when it comes to the evaluation of interventions. However, lifestyle interventions are often complex and subject to several important issues, such as patient preference and non-adherence, that may threaten the internal and external validity of studies. There is a strong demand for high-quality randomized controlled trials of interventions that promote healthy lifestyle behaviours. With this tutorial we aim to provide guidance in the choice of an optimal randomized controlled trial design in future trials of lifestyle interventions.

Association Between Mind-Body Practice and Cardiometabolic Risk Factors: The Rotterdam Study.

OBJECTIVES: The increased popularity of mind-body practices highlights the need to explore their potential effects. We determined the cross-sectional association between mind-body practices and cardiometabolic risk factors. METHODS: We used data from 2579 participants free of cardiovascular disease from the Rotterdam Study (2009-2013). A structured home-based interview was used to evaluate engagement in mind-body practices including meditation, yoga, self-prayer, breathing exercises, or other forms of mind-body practice. We regressed engagement in mind-body practices on cardiometabolic risk factors (body mass index, blood pressure, and fasting blood levels of cholesterol, triglycerides, and glucose) and presence of metabolic syndrome. All analyses were adjusted for age, sex, educational level, smoking, alcohol consumption, (in)activities in daily living, grief, and depressive symptoms. RESULTS: Fifteen percent of the participants engaged in a form of mind-body practice. Those who did mind-body practices had significantly lower body mass index (ß = -0.84 kg/m, 95% confidence interval [CI] = -1.30 to -0.38, p < .001), log-transformed triglyceride levels (ß = -0.02, 95% CI = -0.04 to -0.001, p = .037), and log-transformed fasting glucose levels (ß = -0.01, 95% CI = -0.02 to -0.004, p = .004). Metabolic syndrome was less common among individuals who engaged in mind-body practices (odds ratio = 0.71, 95% CI = 0.54-0.95, p = .019). CONCLUSIONS: Individuals who do mind-body practices have a favorable cardiometabolic risk profile compared with those who do not. However, the cross-sectional design of this study does not allow for causal inference and prospective, and intervention studies are needed to elucidate the association between mind-body practices and cardiometabolic processes.

Mind-body practices for patients with cardiac disease: a systematic review and meta-analysis.

BACKGROUND: Due to new treatment modalities in the last decades, a decline in cardiovascular deaths has been observed. There is an emerging field of secondary prevention and behavioural programmes with increased interest in the use of mind-body practices. Until now, these have not been established in cardiovascular disease treatment programmes. DESIGN: We performed a systematic review and meta-analysis of the available evidence on the effectiveness of mind-body practices for patients with diagnosed cardiac disease. METHODS: We included randomized controlled trials (RCTs), published in English, reporting mind-body practices for patients with diagnosed cardiac disease. EMBASE, MEDLINE, Pubmed, Web of Science, The Cochrane Central Register of Controlled Trials and PsycINFO were searched up to July 2013. Two reviewers independently identified studies for inclusion and extracted data on study characteristics, outcomes (Quality of Life, anxiety, depression, physical parameters and exercise tolerance) and quality assessment. Standardized effect sizes (Cohen's d) were calculated comparing the outcomes between the intervention and control group and random effects meta-analysis was conducted. RESULTS: We identified 11 unique RCTs with an overall low quality. The studies evaluated mindfulness-based stress reduction, transcendental meditation, progressive muscle relaxation and stress management. Pooled analyses revealed effect sizes of 0.45 (95%CI 0.20-0.72) for physical quality of life, 0.68 (95%CI 0.10-1.26) for mental quality of life, 0.61 (95%CI 0.23-0.99) for depression, 0.52 (95%CI 0.26-0.78) for anxiety, 0.48 (95%CI 0.27-0.69) for systolic blood pressure and 0.36 (95%CI 0.15-0.57) for diastolic blood pressure. CONCLUSIONS: Mind-body practices have encouraging results for patients with cardiac disease. Our review demonstrates the need for high-quality studies in this field.

Association between N-terminal pro-brain natriuretic peptide and quality of life in adult patients with congenital heart disease.

AIMS: Advances in medical treatment have resulted in increased life expectancy in congenital heart disease. Consequently, the focus of management has shifted from reducing mortality to reducing long-term morbidity with the goal of improving quality of life. A predictor of quality of life might be N-terminal pro-brain natriuretic peptide, a well-established marker for heart failure. We aimed to determine the association between N-terminal pro-brain natriuretic peptide and quality of life in patients with congenital heart disease. METHODS: We collected blood samples from consecutive patients who were initially operated between 1968 and 1980 (47.8% women; mean age 40.2±5.4 years). The 36-item Short-Form Health Survey was completed to assess subjective health status as a measure of quality of life. Analysis was performed for the entire group and for subgroups defined as simple versus complex congenital heart diseases. Median N-terminal pro-brain natriuretic peptide level was 15.2 pmol/L (overall range 1.3-299.3 pmol/L). N-terminal pro-brain natriuretic peptide levels were associated with the subdomain physical functioning (ß=-0.074, p=0.031). This association remained significant after adjustment for age and sex (ß=-0.071, p=0.038) and after adjustment for age, sex, body mass index, left ventricular function, and renal function (ß=-0.069, p=0.048). In complex congenital heart disease, the association between N-terminal pro-brain natriuretic peptide and physical functioning remained significant in multivariable analysis (ß=-0.076, p=0.046). No associations were found in the simple congenital heart disease group or on the other health status subdomains. CONCLUSION: In adults operated for congenital heart disease, N-terminal pro-brain natriuretic peptide is associated with the subdomain physical, primarily in the complex subgroup.

Effects of lifestyle-related interventions on blood pressure in low and middle-income countries: systematic review and meta-analysis.

Despite the overwhelming evidence supporting the effectiveness of antihypertensive medication, hypertension remains poorly controlled in low and middle-income countries (LMICs). Lifestyle intervention studies reporting effects on blood pressure published from January 1977 to September 2012 were searched on various databases. From the 6211 references identified, 52 were included in the systematic review (12, 024 participants) and 43 were included in the meta-analysis (in total 6779 participants). We calculated and pooled effect sizes in mmHg with random-effects models. We grouped interventions into behavioral counseling (1831 participants), dietary modification (1831 participants), physical activity (1014 participants) and multiple interventions (2103 participants). Subgroup analysis and meta-regression were used to evaluate origins of heterogeneity. Lifestyle interventions significantly lowered blood pressure levels in LMIC populations, including in total 6779 participants. The changes achieved in SBP (95% confidence interval) were: behavioral counseling -5.4 (-10.7, -0.0) mmHg, for dietary modification -3.5 (-5.4, -1.5) mmHg, for physical activity -11.4 (-16.0, -6.7) mmHg and for multiple interventions -6.0 (-8.9, -3.3) mmHg. The heterogeneity was high across studies and the quality was generally low. Subgroup analyses showed smaller samples reporting larger effect sizes; intervention lasting less than 6 months showed larger effect sizes and intention-to-treat analysis showed smaller effect sizes Lifestyle interventions may be of value in preventing and reducing blood pressure in LMICs. Nevertheless, the overall quality and sample size of the studies included were low. Improvements in the size and quality of studies evaluating lifestyle interventions are required.

Obesity, health status, and 7-year mortality in percutaneous coronary intervention: in search of an explanation for the obesity paradox.

BACKGROUND: Obesity is a growing health problem and is associated with adverse outcomes in coronary artery disease (CAD). However, recent studies have shown better survival in cardiovascular patients with overweight or obesity, which has been referred to as the "obesity paradox". As there is no clear understanding of the phenomenon, we examined the association between body mass index (BMI) and all-cause mortality in patients treated with percutaneous coronary intervention (PCI) at 7-year follow-up, and the potential role of health status in explaining the obesity paradox. METHODS: Consecutive PCI patients (72.5% men; mean age 62.0 ± 11.2 years, range [27-90]years) from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry completed the 36-item short-form health survey (SF-36) to assess health status at baseline. Patients were classified into a normal weight, overweight or obesity group. RESULTS: The prevalence of normal weight was 34.7% (354/1019), overweight was seen in 45.9% (468/1019) of patients, and 19.3% (197/1019) was obese. After a median follow-up of 7.0 ± 1.7 years, 163 deaths (16.0%) from any cause were recorded. Cumulative hazard functions differed significantly for the obese and overweight group when compared to the normal weight group (log-rank X(2)=6.59, p<0.05). In multivariable analysis, overweight, but not obesity, remained associated with a lower risk for all-cause mortality (HR=0.60, 95%CI [0.42-0.86], p=0.005). Additionally, after adding the 8 health status SF-36 domains to the multivariate model, the association between overweight and mortality remained unchanged. CONCLUSION: In our study population overweight, but not obesity, was associated with a lower risk for 7-year mortality in PCI patients. Health status as measured with the SF-36 did not seem to play a role in explaining the obesity paradox.

Effect of anemia on short- and long-term outcome in patients hospitalized for acute coronary syndromes.

Anemia is common in hospitalized cardiac patients and is associated with adverse outcomes. The aim of this study was to identify the association of anemia with early and long-term outcomes in patients with acute coronary syndromes (ACSs). Included were 5,304 consecutive patients (73% men, 61 ± 12 years of age) admitted to a coronary care unit from 1985 through 2008 for ACS. According to the World Health Organization, anemia was defined as serum hemoglobin levels <13 g/dl for men and <12 g/dl for women. Anemia was divided into tertiles to compare mild, moderate, and severe anemia to nonanemia. For trend analyses the study population was categorized in 3 groups: 1985 to 1990, 1991 to 2000, and 2001 to 2008. Outcome measurements were all-cause mortality at 30-days and 20 years. Anemia was present in 2,016 patients (38%), of whom 655 had mild anemia, 717 moderate anemia, and 646 severe anemia. Median follow-up duration was 10 years (range 2 to 25). Compared to nonanemia, adjusted hazard ratios (HRs) for mortality at 30 days were 1.40 for moderate anemia (95% confidence interval [CI] 1.04 to 1.87) and 1.67 for severe anemia (95% CI 1.25 to 2.24). At 20 years HRs were 1.13 for moderate anemia (95% CI 1.01 to 1.27) and 1.39 for severe anemia (95% CI 1.23 to 1.56). In addition, survival during hospitalization improved over time. Compared to 1985 to 1990 adjusted HRs were 0.52 for 1991 to 2000 (95% CI 0.41 to 0.66) and 0.36 for 2001 to 2008 (95% CI 0.25 to 0.51). In conclusion, presence and severity of anemia is an important predictor of higher in-hospital and long-term mortality after ACS. In addition, since the 1980s in-hospital outcome of patients with ACS and anemia has improved.