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Background Due to the demographic ageing process and the increasing number of pre-frail and frail individuals, new lifestyle interventions to enhance the quality of life (QoL) in community-dwelling older adults are necessary. Therefore, we performed a randomised controlled trial (RCT) to compare effects of a lay-led home-based physical and nutritional intervention programme with social support alone on different QoL domains in community-dwelling pre-frail and frail older adults. Methods In this analysis within a RCT (12 weeks), lay volunteers visited one-on-one pre-frail or frail older adults at home twice a week. Participants in the physical training and nutritional intervention (PTN) group performed six strength exercises and discussed main nutritional issues during each visit. The social support (SOSU) group received home visits twice a week for social exchanges. The QoL was assessed with the WHOQOL-BREF and the WHOQOL-OLD instruments. Analyses of covariance (ANCOVA) were used to examine differences between groups with baseline values as the covariate. Changes within groups were assessed with paired t-tests. Results Eighty participants ( n  = 39 in the PTN group and n  = 41 in the SOSU group) were included. No significant differences were found between the two groups except in past, present and future activities domain [β = 3.66 (95% confidence interval 0.13 to 7.18)] in favour of the PTN group. However, there was some evidence of greater within group improvements in the PTN group particularly in overall QoL, social relations and social participation. In the SOSU group, no significant effect was observed in any QoL domain. Conclusion A combination of a home-based physical and nutritional intervention was not more effective compared to social support alone, on QoL in community-dwelling pre-frail and frail older adults. However, the small but significant improvement within the PTN group suggests that a home-based physical and nutritional intervention delivered by volunteers may influence the QoL in a positive way. Trial registration The study protocol was registered on 6 November 2013 at ClinicalTrials.gov (identifier: NCT01991639 ).

Background/objectivesRegular monitoring of food intake is hardly integrated in clinical routine. Therefore, the aim was to examine the validity, accuracy, and applicability of an appropriate and also quick and easy-to-use tool for recording food intake in a clinical setting.Subjects/methodsTwo digital photography methods, the postMeal method with a picture after the meal, the pre–postMeal method with a picture before and after the meal, and the visual estimation method (plate diagram; PD) were compared against the reference method (weighed food records; WFR). A total of 420 dishes from lunch (7 weeks) were estimated with both photography methods and the visual method. Validity, applicability, accuracy, and precision of the estimation methods, and additionally food waste, macronutrient composition, and energy content were examined.ResultsTests of validity revealed stronger correlations for photography methods (postMeal: r = 0.971, p < 0.001; pre–postMeal: r = 0.995, p < 0.001) compared to the visual estimation method (r = 0.810; p < 0.001). The pre–postMeal method showed smaller variability (bias < 1 g) and also smaller overestimation and underestimation. This method accurately and precisely estimated portion sizes in all food items. Furthermore, the total food waste was 22% for lunch over the study period. The highest food waste was observed in salads and the lowest in desserts.ConclusionsThe pre–postMeal digital photography method is valid, accurate, and applicable in monitoring food intake in clinical setting, which enables a quantitative and qualitative dietary assessment. Thus, nutritional care might be initiated earlier. This method might be also advantageous for quantitative and qualitative evaluation of food waste, with a resultantly reduction in costs.

In patients with coronary heart disease the further course of the disease can be substantially influenced by means of a targeted treatment of risk factors. A reduction of hospital referrals, an improvement in quality of life and an extension in life expectation by secondary prophylactic measures have been well documented. In addition to an optimized medicinal therapy, an often drastic change in lifestyle with a focus on a consistent abstinence from nicotine, a healthy diet and regular physical exercise is necessary. Data from healthcare research show that these targets are only insufficiently achieved. The implementation of current guidelines should therefore be rigorously applied. There is a need for research particularly with respect to the prognostic significance of beta blocker therapy for patients with stable coronary heart disease and preserved left ventricular function, the prognostic significance of targeted weight loss for overweight or obese coronary heart disease patients, the effectiveness of psychosocial interventions in the various patient groups and their implementation into routine care. Research is also necessary with respect to optimization of structured rehabilitation programs and improvement in patient compliance.

Patients with coronary heart disease (CHD) and type 2 diabetes mellitus (T2DM) have a substantially increased risk for major cardiovascular events and mortality. Increasing physical activity and improving a healthy diet may effectively reduce cardiovascular risk factors; however, the effects are often transient. In a multicenter, 1:1 randomized controlled trial including 502 patients with combined CHD and T2DM (68 ± 8 years; 84% men), we assessed the effects of a home-based telemedicine-supported lifestyle intervention (exercise training, nutritional recommendations and health literacy training) with regular individualized feedback versus usual care. The study met its primary endpoint of reduced glycated hemoglobin after 6 months in favor of the lifestyle intervention group (mean between-group difference in the complete-case analysis ( n  = 197 and n  = 193), −0.13% (95% confidence interval, −0.25 to −0.01), P  = 0.04). When individualized feedback and health literacy training were discontinued after 6 months (while other telemedicine tools were maintained), no statistically significant between-group differences were observed at 12 months. At 12 months, 31 patients (6.2%) had a major adverse cardiovascular event (lifestyle intervention, n  = 20 (8.0%); usual care, n  = 11 (4.4%); P  = 0.15), with the main reason being hospitalization for angina or revascularization (lifestyle intervention, n  = 15; usual care, n  = 8). There were five deaths (lifestyle intervention, n  = 2; usual care, n  = 3), none of which were categorized as related to the intervention. However, three events that resulted in hospitalization were categorized as potentially related to the intervention (decompensation of heart failure, vertebral disc prolapse and inguinal hernia). In conclusion, a home-based lifestyle intervention with telemedicine support showed modest effects in patients with CHD and T2DM. ClinicalTrials.gov registration: NCT03835923 . A randomized controlled trial showed that a home-based, telemedicine-supported lifestyle intervention, which consisted of exercise training, nutrition recommendations and health literacy training, reported improved glycemic control after 6 months in patients with coronary heart disease and type 2 diabetes compared to usual care.

The aim of the study was to compare the effects of home visits with physical training and nutritional support on inflammatory parameters to home visits with social support alone within a randomized controlled trial. Prefrail and frail persons received home visits from lay volunteers twice a week for 12 weeks. Participants in the physical training and nutritional intervention group (PTN, n = 35) conducted two sets of six strength exercises and received nutritional support. The social support group (SoSu, n = 23) received visits only. TNF-α, IL-6, CRP, and total leukocyte count were assessed at baseline and after 12 weeks. Changes over time within groups were analyzed with paired t-tests; differences between groups were analyzed with ANCOVA for repeated measurements. In the PTN group, IL-6 and CRP remained stable, whereas in the SoSu group, IL-6 increased significantly from a median value of 2.6 pg/l (min-max = 2.0-10.2) to 3.0 pg/l (min-max = 2.0-20.8), and CRP rose from 0.2 mg/dl (min-max = 0.1-0.9) to 0.3 mg/dl (min-max = 0.1-3.0) after 12 weeks. In CRP, a significant difference between groups was found. TNF-α and total leukocyte count did not change in either the PTN group or the SoSu group. Persons showing an increase in physical performance (OR 4.54; 95% CI = 1.33-15.45) were more likely to have constant or decreased IL-6 values than persons who showed no improvement. In conclusion, in non-robust older adults, a physical training and nutritional support program provided by lay volunteers can delay a further increase in some inflammatory parameters.

•V-DIfference examines inclisiran vs placebo in hypercholesterolemia on top of individualized LLTs.•A phase 4, randomized, multicenter, double-blind trial.•Investigating the early efficacy, safety, and QoL with inclisiran vs. SoC.•Participants switched to rosuvastatin will receive a CV risk based optimized LLT. Twice-yearly inclisiran (after the initial and 3-month doses) provides effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction in individuals with hyperlipidemia with a favorable long-term safety profile. Limited studies have assessed the impact of inclisiran on the quality of life (QoL) of patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalent. The VICTORION-Difference study will evaluate the early efficacy, safety, and QoL outcomes with inclisiran compared to placebo on top of individually optimized lipid-lowering therapy. This phase 4, randomized, double-blind, placebo-controlled trial includes participants aged ≥18 years with hypercholesterolemia at high or very high cardiovascular (CV) risk despite being treated with an individualized maximally tolerated statin dose. Participants are randomized 1:1 to receive either subcutaneous injections of 300-mg inclisiran sodium (equivalent to 284-mg inclisiran) or placebo. In addition to the treatment with inclisiran/placebo, open-label rosuvastatin (starting dose of 5 mg/day or 10 mg/day) is sequentially and optimally titrated to the maximally tolerated dose, if the individual LDL-C goals are not achieved. The primary objective is to assess the achievement of LDL-C goals at day 90. Secondary objectives include the assessment of muscle-related adverse events, pain-related QoL scores, and mean LDL-C reduction. The results of the study will be disseminated through peer-reviewed journals, conference presentations, and other scientific forums to inform clinical practice and future research in the field of hypercholesterolemia and CV disease management. Unique identifier: NCT05192941.

Background: Little is known about the implementation of lifestyle interventions in frail, community-dwelling people. This study highlights different domains of adherence to explain an effectively delivered home-based intervention. Methods: Eighty prefrail and frail persons (≥65 years) participated in a physical training, nutritional, and social support intervention over 24 weeks. A detailed log book was kept for comprehensive documentation in order to assess adherence and further organizational, exercise, and nutritional parameters. Results: Participants reached an adherence rate (performed home visits/number of planned visits) of 84.0/80.5% from week 1–12/13–24. Out of those, 59% carried out ≥75% of the offered visits. Older age was associated with a higher adherence rate. A mean of 1.5 (0.6) visits/week (2 were planned) were realized lasting for a mean of 1.5 (0.9) hours (154% of the planned duration). Per visit, 1.2 (0.6) circuits of strength training were performed (60.5% of the planned value) and 0.5 (0.3) nutritional interventions (47%). After twelve months, 4.2% still carried out the home visits regularly and 25.0% occasionally. Conclusion: Adherence is much more than “being there”. Adherence rate and category are limited parameters to describe the implementation of a complex lifestyle intervention, therefore a comprehensive documentation is needed.

BackgroundLittle is known about changes in bone mineral density (BMD) following weight loss after one-anastomosis gastric bypass (OAGB) and the role of serum vitamin D and its supplementation on bone metabolism. We evaluated BMD after OAGB as a function of vitamin D supplementation with respect to a minimum threshold of 25-hydroxy-vitamin-D [25(OH)D] concentration, which could prevent or decelerate an eventual bone loss.MethodsFifty bariatric patients who participated in the randomized controlled trial were included in this analysis. BMD and anthropometric measurements by DXA and laboratory parameters were assessed before (T0), at 6 (T6), and 12 months (T12) after surgery.ResultsOAGB resulted in a 36% total body weight loss with a decrease in body fat and an increase in lean body mass. A significant decrease in BMD was seen in lumbar spine by 7%, left hip 13%, and total body 1%, but not in forearm. Bone turnover markers increased significantly but with normal parathyroid hormone concentrations. Weight loss was not associated with changes in BMD. A serum 25(OH)D concentration > 50 nmol/l at T6 and T12 (adequate-vitamin-D-group; AVD) showed a significant lower bone loss, compared to the inadequate-vitamin-D-group (IVD; < 50 nmol/l). Lower bone loss in the left hip showed a strong correlation with higher 25(OH)D concentrations (r = 0.635, p = 0.003).ConclusionThese findings support a dose effect of vitamin D supplementation on bone health and suggest that 25(OH)D concentrations need to be above 50 nmol/l at least during the first postoperative year to decelerate bone loss in patients undergoing OAGB.Clinical Trial Registry Number and WebsiteClinicaltrials.gov (NCT02092376) at https://clinicaltrials.gov/.EudraCT (2013-003546-16) at https://eudract.ema.europa.eu/.

Aims Educational attainment might impact secondary prevention after myocardial infarction (MI). The purpose of the present study was to compare the rate of risk factors and the efficacy of an intensive prevention program (IPP), performed by prevention assistants and supervised by physicians, in patients with MI and different levels of education. Methods In this post hoc analysis of the multicenter IPP and NET-IPP trials, patients with MI were stratified into two groups according to educational attainment: no “Abitur” (no A) vs. “Abitur” or university degree (AUD). The groups were compared at the time of index MI and after 12-month IPP vs. usual care. Results Out of n  = 462 patients with MI, 76.0% had no A and 24.0% had AUD. At the time of index, MI rates of obesity (OR 2.4; 95%CI 1.4–4.0), smoking (OR 2.2, 95%CI 1.4–3.6), and physical inactivity (OR 1.6; 95%CI 1.0–2.5) were significantly elevated in patients with no A. At 12 months after index MI, larger improvements of the risk factors smoking and physical inactivity were observed in patients with IPP and no A than in patients with IPP and AUD or with usual care. LDL cholesterol levels were reduced by IPP compared to usual care, with no difference between no A vs. AUD. A matched-pair analysis revealed that high baseline risk was an important reason for the large risk factor reductions in patients with IPP and no A. Conclusion The study demonstrates that patients with MI and lower educational level have an increased rate of lifestyle-related risk factors and a 12-month IPP, which is primarily performed by non-physician prevention assistants, is effective to improve prevention in this high-risk cohort. Graphical Abstract

Abstract Aims Exercise training improves aerobic capacity (V̇O2peak) in patients with heart failure and preserved ejection fraction (HFpEF), but underlying mechanisms remain unclear. We aimed to evaluate whether exercise training could improve systolic and diastolic function during exercise. Methods This was a substudy of the multicentre Optimizing Exercise Training in HFpEF (OptimEx-Clin) trial, in which 180 patients with HFpEF were randomized 1:1:1 to guideline control, moderate continuous training or high-intensity interval training. All patients included at two out of five participating sites underwent exercise echocardiography at baseline and 3 months. Patients of both training groups were pooled and compared with guideline control. Results A total of 61 patients (mean age 73 ± 7 years, 72% female) were included. At baseline, E/e′ increased from 17.0 ± 5.7 to 19.5 ± 6.1 and systolic pulmonary artery pressure from 31 ± 8 to 51 ± 11 mmHg (both P < 0.001). Right ventricular function did not change significantly (maximal tricuspid annular plane systolic excursion 24.7 ± 4.0 mm, P = 0.051 vs. baseline). At 3 months, patients randomized to exercise training improved V̇O2peak (control +0.2, training +2.7 mL/kg/min, P = 0.006) and demonstrated small but significant improvements in exercise E/e′ (control 21.7 ± 7.5 to 22.8 ± 9.2, training 18.3 ± 5.0 to 17.2 ± 4.1, P = 0.044). No significant changes were observed in ejection fraction, mitral or tricuspid annular plane systolic excursion, S′, A′ or systolic pulmonary artery pressure (P > 0.05). Changes in E/e′ were not associated with the change in V̇O2peak. Conclusions In patients with HFpEF, exercise echocardiography revealed increases in filling pressures as well as a failure to augment right ventricular function during exercise. After 3 months of exercise training, HFpEF patients demonstrated a small improvement in diastolic function (exercise E/e′), but this did not explain the improved aerobic capacity. Training-induced change of diastolic function in HFpEF. HIIT, high-intensity interval training; HFpEF, heart failure with preserved ejection fraction; LVEF, left ventricular ejection fraction; MCT, moderate continuous training; TAPSE, tricuspid annular plane systolic excursion; V̇O2peak, peak oxygen uptake.