InterVFast-effectiveness and acceptance of intermittent fasting in cardiac rehabilitation patients: study protocol of a randomized controlled trial.

BACKGROUND: Research on intermittent fasting has shown that it can improve a variety of health outcomes, including blood sugar control, blood lipid levels and blood pressure. Only few studies document longer periods of fasting, especially in rehabilitation participants. Cardiac inpatient rehabilitation follows a multidisciplinary approach including change of health behaviour to reduce patients' risk of future cardiovascular events. To date, evidence suggests that intermittent fasting can be an effective way to improve health and well-being, but more research is needed to fully understand its long-term effects and factors that promote the implementation. Therefore, the aim of the ongoing InterVFast trial is to investigate the effectiveness of intermittent fasting amongst cardiac rehabilitation patients after 4-week inpatient rehabilitation as well as 3 and 12 months subsequently including patients' perspective. METHODS: This single-centre randomized controlled trial evaluates the effectiveness of the InterVFast intervention in weight loss (primary outcome). We also examine patients' acceptance and the effect on relevant outcomes as blood glucose and triglyceride levels, cholesterol and high-sensitivity C-reactive protein. Weight, blood samples and clinical data are collected as part of the initial and final examination during inpatient rehabilitation. During inpatient rehabilitation, participants daily note fasting intervals and meals eaten as well as practicability in a fasting diary. In addition, interviews about perceived advantages and disadvantages and acceptance are carried out with the participants in the IG. A standardized follow-up examination (weight, blood samples) will be carried out by the family doctor after 3 and 12 months (t2 and t3). DISCUSSION: Compared to other weight-loss intervention studies, our study addresses patients with coronary heart disease and includes patients' acceptance as well as long-term maintenance. It is hypothesized that participation in the InterVfast intervention will improve relevant health outcomes in a sample of cardiac rehabilitation patients and thus constitute a behavioural prevention strategy to reduce the risk of future cardiac events and improve overall health and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov DRKS00023983. Registered on February 17, 2022.

How Can Cardiac Rehabilitation Promote Health Literacy? Results from a Qualitative Study in Cardiac Inpatients.

After acute care of a cardiac event, cardiac rehabilitation helps future disease management. Patients with low health literacy have been shown to have fewer knowledge gains from rehabilitation and higher all-cause mortality after acute cardiac events. Cardiac rehabilitation may be the best channel to target population with low health literacy, yet research on this topic is limited. Consequently, the main aim of the current study was to identify patient perceptions about the health literacy domains that are needed for successful rehabilitation of patients attending German cardiac rehabilitation clinics after an acute cardiac event. Five focus group interviews with 25 inpatients (80% male, 20% female) were conducted at a cardiac rehabilitation clinic in Germany. Patients were eligible to participate if they had sufficient understanding of the German language and had no other debilitating diseases. Patients identified five domains of health literacy for rehabilitation success: knowledge about their health condition; being able to find and evaluate health-related information, being able to make plans and sticking to them, assumption of responsibility over one's health and the ability to ask for and receive support. The results give an important insight into what patients perceive as important components of their cardiac rehabilitation, which can provide the basis for developing the health literacy of patients and how cardiac rehabilitation clinics respond to the recovery needs of their patients.

[The Role of Heart-Focused Anxiety in the Need for Psychological Support and Self-Assessment of Early Retirement - Indications from Cardiac Inpatient Rehabilitation]. / Bedeutung der Herzangst für den psychologischen Betreuungsbedarf und die subjektive Erwerbsprognose ­ Hinweise aus der stationären kardiologischen Rehabilitation.

OBJECTIVE: The psychosocial care of cardiac patients is becoming increasingly important. In inpatient cardiac rehabilitation, patients should be ideally screened for psychosocial risk factors and given psychological support. Heart-focused anxiety can significantly impair quality of life and subsequently influence prognosis of the course of the disease as well as social and occupational participation. Due to the difference between reported prevalence of heart-focused anxiety and the observed lower rate of patients expressing need for psychological support, the authors assumed that some patients do not express their need for psychological support. Therefore, aim of the study was to identify these patients through a simple screening instrument in order to offer them appropriate psychological support and consequently to maintain rehabilitation goals, including ability to work. METHODS: We conducted a cross-sectional study at an inpatient cardiac rehabilitation center, Roderbirken, Leichlingen, Germany. Patients completed a standardised questionnaire, consisting of the Cardiac Anxiety Questionnaire, the Hospital Anxiety and Depression Scale and Scale I of the Screening Instrument Work and Occupation. Data were analyzed using descriptive statistics and logistic regression analysis. Ethical approval was obtained. RESULTS: Finally, 507 patients were included in the analysis (82.6% men, mean age 54.4±7.1 years). Of these, 40.0% expressed need for psychological support. Prevalence of heart-focused anxiety was 15.7%; among them significantly more patients expressed need for psychological support (59.0 vs. 41.0%; p<0.05). Also patients with mental disorders expressed need for psychological support (57.6 vs. 0.7%; p<0.05). Subjective assessment of early retirement was associated with heart-focused anxiety and with depressive symptoms (both p<0.001) as well as education and employment status. DISCUSSION: Based on the results of the self-assessment instruments as well as the socioeconomic and clinical patient characteristics, possible indicators of subjective occupational prognosis can be derived. CONCLUSION: An screening through Hospital Anxiety and Depression Scale can facilitate target achievement of return to work in cardiac rehabilitation.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 1.

BACKGROUND: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. METHODS: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the "Association of the Scientific Medical Societies in Germany" (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. RESULTS: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on "treatment intensity" including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. CONCLUSIONS: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.

[Are Intensified Secondary Prevention Programmes Effective Interventions to Reduce Disability-Related Early Retirement After Cardiac Rehabilitation?] / Weniger Erwerbsminderungsrenten nach der kardiologischen Rehabilitation durch intensivierte Nachsorge?

PURPOSE: We aimed to combine follow-up data from 3 randomized controlled studies to evaluate the effectiveness of intensified (telephone-based) secondary prevention programmes on disability-related early retirement. METHODS: Each trial (SeKoNa, Sinko and OptiHyp) compared an intensified (telephone-based) secondary prevention concept as an intervention to an untreated control group (standard management). We extracted extensive baseline data on sociodemographic, clinical and diagnostic characteristics on an individual patient level from the original trial data sets. Follow-up analysis is based on routine data of the German Pension Insurance Rhineland (obtained in August 2019). The primary outcome parameters are mortality (all causes), recurrent cardiac events, and employment status three years after rehabilitation. Here we report results regarding disability-related early retirement. Outcome data were pooled with via meta-analysis for individual patient data (Individual Patient Data Meta-Analysis IPD-MA) using classical meta-analytical techniques (one-stage approach using mixed models and 2-stage approach with inverse variance estimation as fixed effects model). RESULTS: A total of 1058 cardiac rehabilitation patients were included in the analyses. There were no differences between the pooled intervention group (n=499) and the pooled control group (n=559) regarding any baseline parameter at discharge after 3-week cardiac rehabilitation. There are no indications of statistical heterogeneity. In the total sample incident disability-related early retirement rate was 11.8% at 3-year follow-up. Participation in an intensified secondary prevention programme reduced the risk by about 60% compared to the control group (OR: 0.43; 95% CI: 0.36-0.51). CONCLUSION: The need for effective rehabilitation programmes is rapidly growing due to the current demographic trend with an increase in ageing working populations. Secondary prevention programmes following 3-week inpatient rehabilitation are an effective tool to sustainably support the prevention of health-related premature reduction in earning capacity pensions and therefore should complement the existing rehabilitation offer. Based on our results we conclude that secondary prevention should be provided long enough (at least one year) and in personal contact.

Health-related quality of life after heart surgery - Identification of high-risk patients: A cohort study.

BACKGROUND: This cohort study evaluated factors, which have been shown to be relevant for Health-Related Quality of Live (HRQL) after cardiac surgery and investigated the combinatory impact on HRQL. Additionally, the aim was to introduce a first attempt to developing a risk estimation model which could identify patients at risk for impaired HRQL. METHODS: For this single-centre cohort study, 6099 cardiac surgical patients (60% isolated coronary bypass surgery) filled in the Nottingham Health Profile (NHP) for the evaluation of HRQL six months after surgery and provided information regarding their medical and socio-demographic status. For the NHP scores the deviation to the matched normative data of a healthy sample was calculated. A robust linear regression examined factors that influence HRQL. As a next step, based on the regression model, a risk estimation model was developed which is a first attempt to classify patients into risk categories. RESULTS: Male gender, age below 60 or between 60 and 74 years, living alone, no occupation, bypass surgery, NYHA status II, III or IV and chest pain were identified as risk factors to determine impaired HRQL. The model explains 29.13% of the variance. Based on the risk estimation model 27.4% were classified as medium or high risk. CONCLUSIONS: For the first time a multilevel method was applied to evaluate HRQL after heart surgery showing that socio-demographic variables are important co-factors to dyspnea and chest pain. We take a first attempt in developing a new approach that should encourage further research in this field to frame a screening tool that may help identifying patients at risk in the future.

Efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on risk and health-related quality of life in a low-education cohort: a randomized controlled study.

OBJECTIVE: The aim of this study was to evaluate the efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on cardiovascular risk and health-related quality of life in a cohort of middle-aged (≤58 years) coronary artery disease (CAD) patients of low educational level compared to usual care. DESIGN AND METHODS: The study included 600 patients with CAD, with 271 in the intervention group (IG) and 329 in the control group (CG). The average age was nearly 50 years in both groups, nearly 90% were male, and 77% had less than 10 years of school education. No significant differences existed between the groups at baseline. Both groups had a 3-week comprehensive cardiovascular inpatient rehabilitation programme at the beginning, the intervention consisted of one further rehabilitation session in hospital after 6 months and regular telephone reminders over a period of 36 months. Analyses were conducted on an intention-to-treat basis. To evaluate the individual risk level, we used the PROCAM score and intima-media thickness (IMT) was measured at the common carotid artery on both sides following international standards. Health-related quality of life was assessed with the EUROQOL and HADS. RESULTS: Patients in the IG showed better 3-year risk profile outcomes. The PROCAM score increased by 3.0 (IG) and by 3.7 (CG) from the beginning to after 3 years (p > 0.05 intention-to-treat). The average IMT increased by 0.04 mm in the CG and was reduced by 0.03 mm in the IG (p = 0.014 for the difference). The IG had a significant improvement in health-related quality of life. Mortality, myocardial infarction, and stroke were not different although 'other cardiac events' (cardiac surgery or intervention) were significantly lower in the IG than the CG patients (p < 0.05). CONCLUSION: This long-term secondary prevention programme with inpatient rehabilitation at the beginning and telephone reminder for a 3-year period was successful. There were significant differences in health-related quality of life between the IG and CG, despite the relatively positive outcomes in the CG. In this low-education (predominantly male), middle-aged cohort, the positive impact on cardiovascular risk was pronounced in the high-risk subgroup (PROCAM 10-year risk 10-40%).

[Effects of a phase II cardiac rehabilitation program performed on an outpatient basis]. / Die effektivität einer ambulanten kardiogischen Rehabilitation der Phase II. Modellprojekt der LVA-Rheinprovinz und der rheinschen Krankenhassen zur ambulanten/teilstationären kardiologischen Rehabilitation.

BACKGROUND AND OBJECTIVE: In Germany, phase II cardiac rehabilitation has always been carried out on an inpatient basis. Meanwhile, the governmental health authorities are demanding more flexible solutions for cardiac rehabilitation. The objective of this study is to examine the effects of phase II cardiac rehabilitation performed on an outpatient basis (OCR) in a larger patient cohort. These are the first results of patients before and directly after the OCR performed at six different rehabilitation centers. PATIENTS AND METHODS: The study group consisted of 479 men and 74 women, 56.1 +/- 11.5 years. Cardiovascular indications for the OCR were myocardial infarction in 219 cases, coronary artery disease (CAD) in 92, in 84 cases with invasive procedures, coronary artery bypass graft in 185, cardiac valve surgery in 26, and other cardiac diseases in 29. 70% of the patients were worker, 25% without professional training. Staying with the family (42%) and aversion to stationary programs (61%)were the main reasons for the choice of OCR. Without OCR,27.4% would have refused any rehabilitation program. RESULTS: Maximal physical performance increased from 97.8 + - 31.4 to 120.4 +/- 37.3 W (p < 0.001). LDL cholesterol was reduced from 145.9 +/- 42.7 to 117.5 +/- 34.7 mg% (p < 0.001), triglycerides from 203.3 +/- 136.0 to 161.9 +/- 91.6 mg% (p < ).010), HDL cholesterol increased from 39.8 + 11.2 to 41.0 +/- 11.3 mg% (p = 0.003). The use of lipid-lowering therapy in CAD patients increased from 63.1% to 80.7%. A reduction in body mass index from 27.1 +/- 3.6 to 26.9 +/- 3.5 kg/m2 (p = 0.010) was demonstrated. The number of active smokers decreased from 53.8% to 25.6%. CONCLUSION: The results obtained are interesting with respect to the patients' social status. With 70% general laborers, our cohort is in contrast to previously published OCR data. On the whole, these results demonstrate that rehabilitative measures can also be implemented on an outpatient basis, without a decrease in the quality of treatment. This also applies to patients who represent lower socioeconomic levels. The results should motivate to work harder and more sufficiently on the development of more flexible cardiac rehabilitation programs.