Critical outcomes to be included in the Core Outcome Set for nutritional intervention studies in older adults with malnutrition or at risk of malnutrition: a modified Delphi Study.

INTRODUCTION: As part of the development of an agreed minimum set of outcomes or Core Outcome Set (COS) for future nutritional intervention trials in older adults with malnutrition or at risk of malnutrition, this work reports on the Delphi surveys and final consensus. METHODS: Outcomes from a scoping review were incorporated into a two-round Delphi survey. Researchers and healthcare professionals experienced in malnutrition in older adults were invited to take part in an online survey to rate 38 selected outcomes on a nine-point Likert scale ranging from 'not important' to 'critical' for their setting (community, hospital, or long-term care). Consensus for inclusion was reached when ≥75% (or ≥60% if a patient-reported outcome) of the participants scored the outcome as 'critical' and <15% as 'not important'. Resulting outcomes were voted for inclusion or exclusion in the COS in a final online consensus meeting. RESULTS: Ninety-three and 72 participants from diverse professional backgrounds and countries participated in the 1st and 2nd Delphi round, respectively. After both rounds eleven outcomes met the inclusion criteria, largely irrespective of setting. Fifteen participants, representing academia, health care, health policy, industry, and PPI, voted in a final online consensus meeting resulting in ten outcomes: malnutrition status, dietary intake, appetite, body weight or BMI, muscle strength, muscle mass, functional performance, functional limitations, quality of life, and acceptability of the intervention. CONCLUSIONS: Ten outcomes will form the COS which is intended to be used by the scientific community in all future nutritional intervention studies for older adults with malnutrition or at risk of malnutrition. The subsequent phase will establish the appropriate methods to measure these outcomes.

Short physical performance battery is not associated with falls and injurious falls in older persons: longitudinal data of the SCOPE project.

INTRODUCTION: Falls and fall-related injuries in older persons are a major public health problem. Our objective was to study the predictive value of the Short Physical Performance Battery (SPPB) in the cohort of the SCOPE project on falls, injurious falls, and possible difference of prediction between indoors and outdoors falls. METHODS: For this sub-study of the SCOPE project participants reporting no falls at baseline, and survey data on falls at the 12-month and 24-month follow-up were included. Participant´s characteristics were assessed during the baseline interview and medical examinations. Falls as well as injurious falls and fall circumstances were obtained self-reported. SPPB and its association with fallers vs. no fallers at 12 and at 24 months were studied with logistic regression models. RESULTS: The 1198 participants had a median age of 79 years (77-82), and a median SPPB of 10 (8-11), with a 52.5% of female. A total of 227 and 277 falls (12- and 24- month visits, respectively) were reported. In the crude model, the SPPB sum scores (p < 0.001) as well as most single item scores were significant different between fallers and non-fallers over time. However, the association was attenuated in models adjusted for age, sex, marital status, number of medications, quality of life, handgrip strength, and muscle mass [e.g., 12 months; OR 0.94 (0.87-1.02)]. While SPPB fails to differentiate between injurious and non-injurious falls (p = 0.48), a lower SPPB score was associated with falls at home (p < 0.01) after 24 months. CONCLUSION: SBPP was not able to significantly predict the risk of falling as well as experiencing an injurious fall. TRIAL REGISTRATION: This study was registered prospectively on 25th February 2016 at clinicaltrials.gov (NCT02691546).

[Frailty: Prevention]. / Frailty: Prävention.

The Frailty syndrome is usually related to the aging process and chronological age, but it is not an inevitable consequence of it - at least until the final phase of life. Primary care interventions that promote physical activity and nutrition can prevent the progression from pre-frailty to frailty. This article presents the current state of knowledge on primary and secondary prevention of frailty.

Kidney function and other associated factors of sarcopenia in community-dwelling older adults: The SCOPE study.

AIM: Sarcopenia is associated with several factors and medical conditions among older adults, though previous research has shown limitations and inconsistencies, especially regarding chronic kidney disease (CKD). We investigated the clinical and laboratory variables associated with sarcopenia and severe sarcopenia in older adults, focusing on kidney function measures. METHODS: Data from community-dwelling adults aged ≥75 years participating in the SCOPE multicenter prospective cohort study were assessed cross-sectionally. Comprehensive geriatric assessment was conducted; sociodemographic and lifestyle factors, clinical variables and comorbidities, anthropometric and bioelectrical impedance analysis, blood and urine laboratory variables were collected. EWGSOP2 revised criteria were used to define sarcopenia and its severity. Estimated glomerular filtration rate (eGFR) was calculated using creatinine and non-creatinine-based equations, and CKD stages were defined accordingly. RESULTS: 1420 participants were included, prevalence of sarcopenia was 10.6 %, and 6 % had severe sarcopenia. Multivariate logistic regression analysis showed that age [OR =1.14; 95 %CI (1.09-1.19)], body mass index (BMI) [0.83 (0.79-0.88)], disability performing instrumental activities of daily living (IADL) [2.61 (1.69-4.06)], Mini Mental State Examination (MMSE) score <24 [2.75 (1.62-4.67)], osteoporosis [2.39 (1.55-3.67)], and stage 4 CKD defined by CKD-EPIBTP-B2M, a non-creatinine-based eGFR equation [2.88 (1.11-7.49)], were independently associated with sarcopenia; as were specifically with severe sarcopenia, with more pronounced associations. CONCLUSIONS: In community-dwelling older adults, sarcopenia is a relevant condition and is associated with severe CKD, older age, IADL, cognitive impairments, osteoporosis and low BMI. These factors should be assessed for proper identification and management of older patients with sarcopenia, and even more so with severe sarcopenia.

Physical activity and exercise for the prevention and management of mild cognitive impairment and dementia: a collaborative international guideline.

BACKGROUND: Physical activity and exercise have been suggested as effective interventions for the prevention and management of mild cognitive impairment (MCI) and dementia, but there are no international guidelines. OBJECTIVES: To create a set of evidence- and expert consensus-based prevention and management recommendations regarding physical activity (any bodily movement produced by skeletal muscles that results in energy expenditure) and exercise (a subset of physical activity that is planned, structured, repetitive), applicable to a range of individuals from healthy older adults to those with MCI/dementia. METHODS: Guideline content was developed with input from several scientific and lay representatives' societies. A systematic search across multidisciplinary databases was carried out until October 2021. Recommendations for prevention and management were developed according to the GRADE and complemented by consensus statements from the expert panels. RECOMMENDATIONS: Physical activity may be considered for the primary prevention of dementia. In people with MCI there is continued uncertainty about the role of physical activity in slowing the conversion to dementia. Mind-body interventions have the greatest supporting evidence. In people with moderate dementia, exercise may be used for maintaining disability and cognition. All these recommendations were based on a very low/low certainty of evidence. CONCLUSIONS: Although the scientific evidence on the beneficial role of physical activity and exercise in preserving cognitive functions in subjects with normal cognition, MCI or dementia is inconclusive, this panel, composed of scientific societies and other stakeholders, recommends their implementation based on their beneficial effects on almost all facets of health.

Diabetes and factors associated with cognitive and functional decline. The screening for CKD among older people across Europe (SCOPE) study.

BACKGROUND: Type 2 diabetes mellitus (DM) in older people is a heterogeneous condition that exhibits differential characteristics in comparison with younger adults. DM increases the risk of disability, is associated with dementia and loss of function, and cognition may often be interrelated and more pronounced in older patients with DM than in those without. AIMS: Our aim was to evaluate the incidence of functional and/or cognitive impairment in older adults with and without DM, and its associated factors in DM participants. METHODS: A 2-year prospective analysis was conducted in a European multicenter prospective cohort (SCOPE study). Older community-dwelling adults (aged ≥ 75 years) underwent a comprehensive geriatric assessment. New functional and/or cognitive decline was explored. RESULTS: Of 1611 participants, 335 (22.0%) had DM at baseline. The percentage of participants scoring at least one ADL impairment and/or cognitive impairment (MMSE < 24) was similar in both groups (9.6%). Factors associated with any new disability in participants with DM in the multivariate analysis were female sex (OR 3.28, 95% CI 1.42-7.56), history of stroke (OR 4.58, 95% CI 1.64-12.7), and greater IADL dependency (OR 1.08 95% CI 1.02-1.15). DISCUSSION: Association between DM and cognitive or functional decline in outpatients of 75 years and older was not found, but factors such as female gender, history of stroke, and IADL dependency could be related. CONCLUSION: Decline in functional and cognitive status of community-dwelling older adults with DM was similar to participants without DM in a short period of 2 years of follow-up, though several clinical factors may increase its risk in this population.

Essential steps in primary care management of older people with Type 2 diabetes: an executive summary on behalf of the European geriatric medicine society (EuGMS) and the European diabetes working party for older people (EDWPOP) collaboration.

We present an executive summary of a guideline for management of type 2 diabetes mellitus in primary care written by the European Geriatric Medicine Society, the European Diabetes Working Party for Older People with contributions from primary care practitioners and participation of a patient's advocate. This consensus document relies where possible on evidence-based recommendations and expert opinions in the fields where evidences are lacking. The full text includes 4 parts: a general strategy based on comprehensive assessment to enhance quality and individualised care plan, treatments decision guidance, management of complications, and care in case of special conditions. Screening for frailty and cognitive impairment is recommended as well as a comprehensive assessment all health conditions are concerned, including end of life situations. The full text is available online at the following address: essential_steps_inprimary_care_in_older_people_with_diabetes_-_EuGMS-EDWPOP___3_.pdf.

A Core Outcome Set for nutritional intervention studies in older adults with malnutrition and those at risk: a study protocol.

BACKGROUND: Malnutrition (i.e., protein-energy malnutrition) in older adults has severe negative clinical consequences, emphasizing the need for effective treatments. Many, often small, randomized controlled trials (RCTs) testing the effectiveness of nutritional interventions for the treatment of malnutrition showed mixed results and a need for meta-analyses and data pooling has been expressed. However, evidence synthesis is hampered by the wide variety of outcomes and their method of assessment in previous RCTs. This paper describes the protocol for developing a Core Outcome Set (COS) for nutritional intervention studies in older adults with malnutrition and those at risk. METHODS: The project consists of five phases. The first phase consists of a scoping review to identify frequently used outcomes in published RCTs and select additional patient-reported outcomes. The second phase includes a modified Delphi Survey involving experienced researchers and health care professionals working in the field of malnutrition in older adults, followed by the third phase consisting of a consensus meeting to discuss and agree what critical outcomes need to be included in the COS. The fourth phase will determine how each COS outcome should be measured based on a systematic literature review and a second consensus meeting. This will be followed by a dissemination and implementation phase. Patient and Public Involvement (PPI) representatives will contribute to study design, oversight, consensus, and dissemination. CONCLUSIONS: The result of this project is a COS that should be included in any RCT evaluating the effect of nutritional interventions in older adults with malnutrition and those at risk. This COS will facilitate comparison of RCT results, will increase efficient use of research resources and will reduce bias due to measurement of the outcome and publication bias. Ultimately, the COS will support clinical decision making by identifying the most effective approaches for treating and preventing malnutrition in older adults.

Safer cycling in older age (SiFAr): effects of a multi-component cycle training. a randomized controlled trial.

BACKGROUND: The risk of older adults being injured or killed in a bicycle accident increases significantly due to the age-related decline of physical function. Therefore, targeted interventions for older adults to improve safe cycling competence (CC) are urgently needed. METHODS: The "Safer Cycling in Older Age" (SiFAr) randomized controlled trial investigated if a progressive multi-component training program related to cycling improves CC of older adults. Between June 2020 and May 2022, 127 community-dwelling persons living in the area Nürnberg-Fürth-Erlangen, Germany aged 65 years and older were recruited, who are either (1) beginners with the e-bike or (2) feeling self-reported unsteadiness when cycling or (3) uptaking cycling after a longer break. Participants were either randomized 1:1 to an intervention group (IG; cycling exercise program, 8 sessions within 3 months) or an active control group (aCG; health recommendations). The CC as primary outcome was tested not blinded in a standardized cycle course prior and after the intervention period and after 6-9 months, which consists of variant tasks requiring skills related to daily traffic situations. Regression analyses with difference of errors in the cycling course as dependent variable and group as independent variable adjusted for covariates (gender, number of errors at baseline, bicycle type, age and cycled distance) were performed. RESULTS: 96 participants (73.4 ± 5.1 years; 59.4% female) were analyzed for primary outcome. Compared to the aCG (n = 49), the IG (n = 47) made an average of 2.37 fewer errors in the cycle course after the 3 months intervention period (p = 0.004). People with more errors at baseline had higher potential for improvement (B=-0.38; p < 0.001). Women on average made 2.31 (p = 0.016) more errors than men, even after intervention. All other confounders had no significant effect on the difference in errors. The intervention effect was very stable until 6-9 months after the intervention (B=-3.07, p = 0.003), but decreased with a higher age at baseline in the adjusted model (B = 0.21, p = 0.0499). CONCLUSION: The SiFAr program increases cycling skills among older adults with self-perceived needs for improvement in CC and could easily be made available to a broad public due to its standardized structure and a train-the-trainer approach. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov: NCT04362514 (27/04/2020), https://clinicaltrials.gov/ct2/show/NCT04362514 .

Characteristics of older cyclists with self-perceived needs for improvement in cycling competence: SiFAr trial.

BACKGROUND: Older cyclists are in great risk of being injured or killed in a traffic-related accident and their needs should find more consideration in safety guidelines, urban planning, and future intervention programs. OBJECTIVE: The aim for this cross-sectional analysis was to comprehensively explore characteristics of community-dwelling cyclists aged 65 years and older with a self-perceived need to increase cycle competence. METHODS: 118 older adults (mean age 73.3 ± 5.2 years, 61% women) performed a standardized cycle course representing specific cycling skills. Additionally, health and functional assessments were carried out and characteristics regarding demographic, health, falls, bicycle equipment/type and cycling biography/behavior were obtained. RESULTS: The majority (67.8%) of this community-dwelling adults reported being unsafe when cycling and 41.3% had a bicycle fall in the past year. More than half of the participants showed at least one limitation in each of the measured cycling skills. Women significantly had more frequent limitations in four of the cycling skills measured (p ≤ 0.001) compared to men. While no significant differences were found for falls, health and functional characteristics, women and men differed significantly in terms of bicycle type, equipment, and perceived safety (p < 0.001). CONCLUSION: Limitations in cycling should be compensated by preventive bicycle training and a safe cycling infrastructure. Bicycle fit, the wearing of bicycle helmets and promotion of a sense of security while cycling can further reduce accident risk and must find recognition in safety guidelines. In addition, educational initiatives have to dismantle gender-related bicycle stereotypes.

Validation of the German version of the Protein Screener 55.

BACKGROUND/OBJECTIVES: The Protein Screener 55 + (Pro55 + ) is a brief food questionnaire to screen older community-dwelling adults for low protein intake. The result is the predicted probability of protein intake <1.0 g/kg adjusted body weight (aBW)/d ranging from 0-1. For purposes of cross-cultural validation, we translated the Pro55+ into German and tested its discriminative accuracy in detecting low protein intake of older community-dwelling people in Germany. SUBJECTS/METHODS: After translation and pilot-testing, the Pro55+ and the reference standard (3-day dietary record) were completed by 144 participants (81.6 ± 3.9 years, 61.8% female). Discriminative properties were tested by receiver operating characteristic curves and by calculating sensitivity and specificity for different cut-offs of predicted probability (>0.3/>0.5/>0.7) using <1.0 or <0.8 g/kg aBW/d to define low protein intake. RESULTS: Protein intake was <1.0 g/kg aBW/d in 39.6% of the sample and <0.8 g/kg aBW/d in 17.4%. Area under the curve was 62.0% (95%CI 52.6-71.5) and 68.8% (58.1-79.4), respectively. Specificity was 82-90% using probability cut-offs of 0.5 and 0.7 for both protein thresholds. Sensitivity was poor for protein threshold of 1.0 g/kg aBW/d regardless of the used probability cut-offs. For protein threshold of <0.8 g/kg aBW/d, sensitivity was 88.0% (71.8-96.9) using a probability cut-off of 0.09. CONCLUSION: The overall discriminative accuracy of the German Pro55+ to identify older community-dwelling people with low protein intake was poor. However, applying different probability cut-offs allows increasing specificity and sensitivity for 0.8 g/kg aBW/d to levels justifying the use for certain purposes e.g. excluding individuals with adequate protein intake. Further validation is needed.

Exercise and the prevention of major osteoporotic fractures in adults: a systematic review and meta-analysis with special emphasis on intensity progression and study duration.

The role of exercise in preventing osteoporotic fractures is vague, and further recommendations for optimized exercise protocols are very rare. In the present work, we provided positive evidence for exercise effects on the number of osteoporotic fractures in adults, albeit without observing any significant relevance of intensity progression or study duration. INTRODUCTION: Osteoporotic fractures are a major challenge confronting our aging society. Exercise might be an efficient agent for reducing osteoporotic fractures in older adults, but the most promising exercise protocol for that purpose has yet to be identified. The present meta-analysis thus aimed to identify important predictors of the exercise effect on osteoporotic fractures in adults. METHODS: We conducted a systematic search of six literature databases according to the PRISMA guideline that included controlled exercise studies and reported the number of low-trauma major osteoporotic fractures separately for exercise (EG) and control (CG) groups. Primary study outcome was incidence ratio (IR) for major osteoporotic fractures. Sub-analyses were conducted for progression of intensity (yes vs. no) during the trial and the study duration (≤ 12 months vs. > 12 months). RESULTS: In summary, 11 studies with a pooled number of 9715 participant-years in the EG and 9592 in the CG were included. The mixed-effects conditional Poisson regression revealed positive exercise effects on major osteoporotic fractures (RR: 0.75, 95% CI: 0.54-0.94, p = .006). Although studies with intensity progression were more favorable, our subgroup analysis did not determine significant differences for diverging intensity progression (p = .133) or study duration (p = .883). Heterogeneity among the trials of the subgroups (I2 ≤ 0-7.1%) was negligible. CONCLUSION: The present systematic review and meta-analysis provided significant evidence for the favorable effect of exercise on major osteoporotic fractures. However, diverging study and exercise characteristics along with the close interaction of exercise parameters prevented the derivation of reliable recommendations for exercise protocols for fracture reductions. PROSPERO ID: CRD42021250467.

Inflammaging and Blood Pressure Profiles in Late Life: The Screening for CKD among Older People across Europe (SCOPE) Study.

The neutrophil-to-lymphocyte ratio (NLR) is a marker for systemic inflammation. Since inflammation plays a relevant role in vascular aging, the aim of this study was to investigate whether NLR is associated with blood pressure profiles in older adults. This study was performed within the framework of the SCOPE study including 2461 outpatients aged 75 years and over. Mean blood pressure values, namely systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse pressure (PP) were investigated across tertiles of NLR. Change in blood pressure levels in 2 years of follow-up were compared across categories of baseline NLR. Data of 2397 individuals were used, of which 1854 individuals had hypertension. Mean values of blood pressure did not differ across categories of baseline NLR in individuals without hypertension. Individuals with hypertension with a high-range NLR had lower SBP and PP when compared to those in low-range NLR (mean difference SBP -2.94 mmHg, p = 0.032 and PP -2.55 mmHg, p = 0.030). Mean change in blood pressure in 2 years did only slightly differ in non-clinically relevant ranges, when compared across tertiles of baseline NLR. NLR as a marker of inflammaging was not associated with unfavorable blood pressure profiles in older individuals with or without hypertension.

Exercise Reduces the Number of Overall and Major Osteoporotic Fractures in Adults. Does Supervision Make a Difference? Systematic Review and Meta-Analysis.

The purpose of this systematic review and meta-analysis (PROSPERO ID: CRD42021250467) was to evaluate the effects of exercise on low-trauma overall and major osteoporotic fractures (hip, spine, forearm, or humerus fractures) and to determine the corresponding effect of supervision of the exercise program. Our systematic search of six literature databases according to the PRISMA guideline was conducted from January 1, 2013 (ie, date of our last search) to May 22, 2021, and included controlled clinical exercise trials with (i) individuals aged ≥45 years, (ii) cohorts without therapies/diseases related to fractures, (iii) observation periods of ≥3 months, and (iv) the number of low-trauma fractures listed separately for the exercise (EG) and control (CG) groups. We included 20 intervention studies with 21 EGs and 20 CGs comprising a pooled number of participant-years of n = 11.836 in the EG and n = 11.275 in the CG. The mixed-effects conditional Poisson regression revealed significant effects of exercise on low-trauma overall incidence (rate) ratio (IR 0.67, 95% confidence interval [95% CI] 0.51-0.87) and major osteoporotic fractures IR (0.69, 95% CI 0.52-0.92). Heterogeneity between the trials was moderate for low-trauma overall (I2 = 40%) and negligible (I2 < 1%) for major osteoporotic fractures. Supervision of the exercise program plays a significant role in the reductions of overall and major osteoporotic fractures with IR about twice as favorable in the predominately supervised (IR 0.44; 95% CI 0.27-0.73 and 0.38; 0.19-0.76) versus the predominately non-supervised exercise trials (IR 0.83; 95% CI 0.60-1.14 and 0.82; 0.64-1.05). In summary, the present study provides evidence for the positive effect of exercise on low-trauma overall and major osteoporotic fractures in middle aged to older adults. Supervision of the exercise program is a crucial aspect in exercise programs on fracture reduction. Thus, home-based exercise protocols should increasingly implement online classes to ensure widely consistent supervision and monitoring of the exercise program. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Frailty in Nursing Homes-A Prospective Study Comparing the FRAIL-NH and the Clinical Frailty Scale.

OBJECTIVES: Frailty is common in nursing home (NH) residents, but its prevalence in German institutions is unknown. Valid and easy-to-use screening tools are needed to identify frail residents. We used the FRAIL-NH scale and the Clinical Frailty Scale (CFS) to (1) obtain the prevalence of frailty, (2) investigate the agreement between both instruments, and (3) evaluate their predictive validity for adverse health events in German NH residents. DESIGN: Prospective cohort study. SETTING AND PARTICIPANTS: German NH residents (n = 246, age 84 ± 8 years, 67% female). METHODS: Frailty status was categorized according to FRAIL-NH (nonfrail, frail, most frail) and CFS (not frail, mild to moderately frail, severely frail). Agreement between instruments was examined by Spearman correlation, an area under the receiver operating characteristic curve (AUC) with 95% CI, and sensitivity and specificity using the "most frail" category of FRAIL-NH as reference standard. Adverse health events (death, hospital admissions, falls) were recorded for 12 months, and multivariate cox and logistic regression models calculated. RESULTS: According to FRAIL-NH, 71.1% were most frail, 26.4% frail, and 2.5% nonfrail. According to CFS, 66.3% were severely frail, 26.8% mild to moderately frail, and 6.9% not frail. Both scales correlated significantly (r = 0.78; R2 = 60%). The AUC was 0.92 (95% CI 0.88-0.96). Using a CFS cutoff of 7 points, sensitivity was 0.90 and specificity 0.92. The frailest groups according to both instruments had an increased risk of death [FRAIL-NH hazard ratio (HR) 2.19, 95% CI 1.21-3.99; CFS HR 2.56, 95% CI 1.43-4.58] and hospital admission [FRAIL-NH odds ratio (OR) 1.95, 95% CI 1.06-3.58; CFS OR 1.79, 95% CI 1.01-3.20] compared to less frail residents. The FRAIL-NH predicted recurrent faller status (OR 2.57, 95% CI 1.23-5.39). CONCLUSIONS AND IMPLICATIONS: Frailty is highly prevalent in German NH residents. Both instruments show good agreement despite different approaches and are able to predict adverse health outcomes. Based on our findings and because of its simple administration, CFS may be an alternative to FRAIL-NH for assessing frailty in NHs.