Accelerometer-measured physical activity in patients with heart failure and reduced ejection fraction: Determinants and relationship with patient-reported health status.

BACKGROUND: Accelerometer-measured physical activity is an increasingly used endpoint in heart failure (HF) trials. We investigated the determinants of accelerometer-measured physical activity and the relationship with patient-reported health status. METHODS: Post-hoc analysis of the Empire HF trial, including outpatients with HF with reduced ejection fraction (HFrEF). Physical activity was quantified as average accelerometer counts per minute (CPM) with higher values representing higher activity. We investigated associations between activity level and clinical variables, including age, sex, and body mass index, as well as patient-reported health status assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). RESULTS: Complete data were available in 180 (95%) patients (86% male, mean age 65 year). Baseline median physical activity level was 1,318 CPM (Q1-Q3 1,111-1,585). Age and anemia were independently associated with activity level (ß-coefficients: -10 CPM per year age increase [95% CI -16 to -5.1], P = .00015, and -126 CPM for anemia [95% CI -9.1 to -244], P = .035). Significant independent associations were observed between activity level and all KCCQ summary scores (ß-coefficient point estimates of 3.7, 4.6, and 4.9 CPM, all P < .02). For 12-week changes in KCCQ-summary scores, only the KCCQ-CSS was associated with activity level; mean increase of 17.5 CPM [95% CI 1.5 to 34.0], P = 0.032, per 5-point increase in KCCQ-CSS. Associations were not modified by treatment allocation (interaction P-values > .05). CONCLUSIONS: In patients with HFrEF, older age and anemia were independently associated with lower activity. Moreover, physical activity only weakly increased with better health status, suggesting that changes in physical activity reflect improvements in patients' health status to a limited degree. This highlights the need to better understand the endpoint with regards to all other health parameters to ease interpretation in future HF trials.

Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease : A Randomized Controlled Trial.

BACKGROUND: It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated. OBJECTIVE: To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet. DESIGN: 6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078). SETTING: Odense University Hospital in Denmark from November 2016 until June 2020. PARTICIPANTS: 165 participants with T2DM. INTERVENTION: Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins. MEASUREMENTS: Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD. RESULTS: The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A1c (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up. LIMITATION: Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons. CONCLUSION: Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention. PRIMARY FUNDING SOURCE: Novo Nordisk Foundation.

Effectiveness of a Preschool Motor Skill Intervention on Body Mass Index and Movement Behavior: 6-, 18-, and 30-Month Findings From a Cluster Randomized Controlled Trial.

PURPOSE: To study the effectiveness of a preschool staff-delivered motor skills intervention on body composition and physical activity over a 2.5-year time frame. METHODS: In this pragmatic parallel cluster randomized controlled trial (16 preschools), outcome data were collected after 6 (body composition only), 18, and 30 months of intervention. The main physical activity outcomes were accelerometer behavior measures summarizing the total percentage of child daily movement (walk, run, cycle, and standing that included minor movements) and preschool movement during preschool attendance. To estimate between-group mean differences in outcomes, mixed-linear regression analyses including baseline value of the selected outcome and a treatment × time interaction term as a fixed effect were applied. In addition, the baseline preschool and child were included as a random effect. RESULTS: For body mass index, a total of 437 children (90%) had at least one valid baseline and one follow-up assessment. The corresponding numbers for preschool movement and daily movement were 163 (55%) and 146 (49%), respectively. No significant between-group mean difference was identified for body mass index, waist-to-height ratio, or any physical activity outcomes. CONCLUSION: Overall, this preschool motor skills intervention had no effect on either child anthropometry or physical activity, consistent with previous studies.

Essential Improvements in Fat Percentage and Cardiometabolic Fitness After a Residential Stay for Socially Vulnerable Children-With and Without the "11 for Health" Concept.

The Danish Christmas Seal Homes offer a 10-week residential stay for socially vulnerable children. We aimed to examine the effects on body composition and cardiometabolic fitness variables of the standard program (SG) and whether substituting physical activity sessions with sessions from a football-based health education program is beneficial for the participants ("11 for Health"; SG+). Three hundred and nine children participated in SG (12.4 [1.6] y) and 305 in SG+ (12.4 [1.4] y). Fat percentage was lowered by 6% for females (from 37% to 31%) and 8% for males (from 36% to 28%), with no between-group differences. We observed improvements in systolic and diastolic blood pressure (3 and 5 mm Hg, respectively), resting heart rate (10 beats/min), aerobic fitness, jump performance, and relative muscle mass with no between-group differences. Furthermore, there were between-group differences in insulin levels for females (1.7 pmol/L; 95% CI, 0.3 to 3.0) and postural balance for males (1.0 s; 95% CI, 0.0 to 2.0), both in favor of SG+, and covered distance in the Andersen test for females (26 m; 95% CI, 3 to 49) in favor of SG. In conclusion, a 10-week stay at the Danish Christmas Seal Home resulted in clinically relevant improvement in fat percentage and cardiometabolic fitness in socially vulnerable children, regardless of the program type.

Energy Expenditure Prediction from Accelerometry Data Using Long Short-Term Memory Recurrent Neural Networks.

The accurate estimation of energy expenditure from simple objective accelerometry measurements provides a valuable method for investigating the effect of physical activity (PA) interventions or population surveillance. Methods have been evaluated previously, but none utilize the temporal aspects of the accelerometry data. In this study, we investigated the energy expenditure prediction from acceleration measured at the subjects' hip, wrist, thigh, and back using recurrent neural networks utilizing temporal elements of the data. The acceleration was measured in children (N = 33) performing a standardized activity protocol in their natural environment. The energy expenditure was modelled using Multiple Linear Regression (MLR), stacked long short-term memory (LSTM) networks, and combined convolutional neural networks (CNN) and LSTM. The correlation and mean absolute percentage error (MAPE) were 0.76 and 19.9% for the MLR, 0.882 and 0.879 and 14.22% for the LSTM, and, with the combined LSTM-CNN, the best performance of 0.883 and 13.9% was achieved. The prediction error for vigorous intensities was significantly different (p < 0.01) from those of the other intensity domains: sedentary, light, and moderate. Utilizing the temporal elements of movement significantly improves energy expenditure prediction accuracy compared to other conventional approaches, but the prediction error for vigorous intensities requires further investigation.

Daily variation in physical activity during mechanical ventilation and stay in the intensive care unit.

BACKGROUND: Early mobilisation of mechanically ventilated patients during their stay at an intensive care unit (ICU) can improve physical recovery. Yet, an objective and specified description of physical activities while in the ICU is lacking. Therefore, our aim was to describe the objectively assessed type, quantity, and daily variation of physical activity among mechanically ventilated patients while in the ICU. METHOD: In an observational study in two mixed medical/surgical ICUs, we measured body posture in 39 patients on mechanical ventilation using a thigh- and chest-worn accelerometer while in the ICU. The accelerometer describes time spent lying, sitting, moving, in-bed cycling, standing and walking. Descriptive analysis of physical activity and daily variation was done using STATA. RESULTS: We found that mechanically ventilated patients spend 20/24 h lying in bed, 3 h sitting and only 1 h standing, moving, walking or bicycling while in the ICU. Intervals of non-lying time appeared from 9.00 to 12.00 and again from 18.00 to 21.30, with peaks at the hours of 9.00 and 18.00. CONCLUSION: ICU patients on mechanical ventilation were primarily sedentary. Physical activity of mechanically ventilated patients seems to be related to nurse- and/or physiotherapy-initiated activities. There is a need to create an awareness of improving clinical routines, towards active mobilisation throughout the day, for this vulnerable patient population during their stay in the ICU.

Efficacy and mechanisms of an education outside the classroom intervention on pupils' health and education: the MOVEOUT study protocol.

BACKGROUND: Education can create better opportunities for health, and vice versa. Using a so-called 'add-in' approach, school-based physical activity (PA) promotion and prevention of sedentary behaviours can increase pupils' wellbeing and learning and, on the longer term, reduce the risk of non-communicable diseases. A PA 'add-in' approach involves integrating PA into teachers' curricular obligations without being an extra burden as opposed to an 'add-on' approach which requires additional operational resources and include activities that do not explicitly contribute towards curricular targets making them less long-term acceptable in a school-based context. Previous studies investigating education outside the classroom (EOtC) show mutual benefits for both health and education outcomes among children and adolescents. However, the evidence is of mixed quality and questionable certainty, which calls for further investigation. The aim of this study protocol is to describe and discuss the study design and methods to investigate the efficacy and mechanisms of EOtC as a vehicle for health and education. The study investigates the intervention developed and conducted in the TEACHOUT study with updated and strengthened design and measures. METHODS: The efficacy of EOtC will be investigated in a cluster randomised waitlist design. Participants will be pupils in ~54 classes, grades 4-10 (ages 10-15 years) in ~30 Danish elementary schools. Fifteen schools will be randomised to the intervention: a two-day EOtC training course targeting teachers followed by the teachers implementing EOtC >5 hours weekly over the course of one school year. Pre- and post-measures of health (PA and wellbeing) and learning (school motivation and academic achievement) will be collected. Investigation of pedagogical and motivational mechanisms will be based on observations of EOtC. DISCUSSION: The updated randomised controlled design will provide firmer evidence for the efficacy and mechanisms of EOtC and provide knowledge about how mutual benefits of health and education can be obtained. TRIAL REGISTRATION: Registered with ClinicalTrials.gov (ID NCT05237674 ) [University of Copenhagen. MOVEOUT: a Cluster RCT of the Efficacy, Mechanisms, and Mediation of an Education Outside the Classroom Intervention on Adolescents' Physical Activity, 2023], February 14, 2022. Most recently updated on November 23, 2022 (Version 2).

Predictors of Physical Activity Levels in Ambulant/Semiambulant Children and Adolescents With Cerebral Palsy: A Clinical Cohort Study.

Children and adolescents with cerebral palsy (CP) show a reduced physical activity (PA) level compared with their typically developed peers. This study aimed to identify potential predictors of objectively evaluated habitual PA using data from a national clinical registry-the Cerebral Palsy Follow-Up Program (CPFP)-and proxy-reported questionnaires. Data from the CPFP database showed that female sex was associated with a lower PA level. Additional questionnaire data revealed age, popliteal angle limitation, Pediatric Outcomes Data Collection Instrument-Sports and Physical Functioning Scale score, screen time, Functional Mobility Scale score at 50 m, and fatigue as predictors. The proposed models can be used for the prediction and early detection of the PA level and consequently for the potential improvement among ambulant/semiambulant individuals with CP. Further research should investigate the predictive impact of personal, social, and environmental factors on the PA level and the gap in PA levels between girls and boys.

Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial.

AIM: To investigate the efficacy and safety of a non-calorie-restricted low-carbohydrate diet (LCD) on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes (T2D) instructed to maintain their non-insulin antidiabetic medication and physical activity. MATERIALS AND METHODS: In an open-label randomized controlled trial, patients with T2D were randomized 2:1 to either a LCD with a maximum of 20 E% (percentage of total energy intake) from carbohydrates (n = 49) or a control diet with 50-60 E% from carbohydrates (n = 22) for 6 months. Examinations at enrolment and after 3 and 6 months included blood sample analyses, anthropometrics, blood pressure, accelerometer-based assessment of physical activity, and food diaries. Total fat mass and lean mass were determined by dual-energy x-ray absorptiometry scan. The mean difference in change between groups from baseline are reported. RESULTS: The LCD group decreased carbohydrate intake to 13.4 E% and increased fat intake to 63.2 E%, which was -30.5 ± 2.2 E% lower for carbohydrates and 30.6 ± 2.2 E% higher for fat, respectively, compared with the control group (all P < .001). The LCD reduced HbA1c after 3 months (-8.9 ± 1.7 mmol/mol; P < .0001), and this was maintained after 6 months (-7.5 ± 1.8 mmol/mol; P < .0001) compared with the control diet. The LCD also reduced weight (-3.9 ± 1.0 kg), body mass index (-1.4 ± 0.4 kg/m2 ), and waist circumference (-4.9 ± 1.3 cm) compared with the control diet (all P < .01), accompanied by reductions in total fat mass (-2.2 ± 1.0 kg; P = .027) and lean mass (-1.3 ± 0.6 kg; P = .017). No changes in blood lipids or blood pressure were seen after 6 months. The level of physical activity was maintained, and there were no episodes of severe hypoglycaemia. CONCLUSION: A non-calorie-restricted LCD high in fat has significant beneficial effects on glycaemic control and body composition, and does not adversely affect cardiovascular risk factors in patients with T2D. Reducing carbohydrate intake to 10-25 E% appears to be an effective and safe nutritional approach with respect to classical cardiovascular risk factors and hypoglycaemia.

Vitamin D supplementation and increased dairy protein intake do not affect muscle strength or physical function in healthy 6-8-year-old children: the D-pro randomized trial.

PURPOSE: To investigate separate and combined effects of vitamin D supplementation during the extended winter and increased dairy protein intake on muscle strength and physical function in children, and furthermore to explore potential sex differences. METHODS: In a 2 × 2-factorial, randomized winter trial, 183 healthy, 6-8-year-old children received blinded tablets with 20 µg/day vitamin D3 or placebo, and substituted 260 g/day dairy with yogurts with high (HP, 10 g protein/100 g) or normal protein content (NP, 3.5 g protein/100 g) for 24 weeks during winter at 55° N. We measured maximal isometric handgrip and leg press strength, and physical function by jump tests and a 30 s sit-to-stand test. Physical activity was measured by 7-day accelerometry. RESULTS: Baseline (mean ± SD) serum 25-hydroxyvitamin D was 80.8 ± 17.2 nmol/L, which increased to 88.7 ± 17.6 nmol/L with vitamin D supplementation and decreased to 48.4 ± 19.2 nmol/L with placebo. Baseline protein intake was 15.5 ± 2.4 E%, which increased to 18.4 ± 3.4 E% with HP and was unchanged with NP. We found no separate or combined effects of vitamin D supplementation and/or increased dairy protein intake on muscle strength or physical function (all P > 0.20). There was an interaction on the sit-to-stand test (Pvitamin×yogurt = 0.02), which however disappeared after adjusting for physical activity (P = 0.16). Further, vitamin D supplementation increased leg press strength relatively more in girls compared to boys (mean [95% CI] 158 [17, 299] N; Pvitamin×sex = 0.047). CONCLUSION: Overall, vitamin D and dairy protein supplementation during the extended winter did not affect muscle strength or physical function in healthy children. Potential sex differences of vitamin D supplementation should be investigated further. REGISTERED AT CLINICALTRIALS.GOV: NCT0395673.

Associations between children's physical literacy and well-being: is physical activity a mediator?

BACKGROUND: Physical literacy (PL) is a multi-dimensional concept that provides a holistic understanding of movement and physical activity. PL contains an affective, a physical, and a cognitive domain, which together lay the foundation for the individual's capacity and the tendency for participating in physical activities currently and throughout life. PL is increasingly regarded as a 'cause of the causes' to health promotion. Cross-sectional studies have shown associations between children's PL, physical activity behaviours, and well-being. This study aims to examine the associations between Danish children's PL and their physical and psychosocial well-being and whether the associations are mediated by moderate- to vigorous intensity physical activity (MVPA). METHODS: Cross-sectional data from Danish schoolchildren aged 7-13 years were collected in Jan-Dec 2020 in the Danish Assessment of Physical Literacy (DAPL) project. PL was assessed with the DAPL which measures the affective, cognitive, and physical domains of PL. MVPA (min/day) was measured with accelerometers (Axivity), psychosocial well-being was measured with The Strengths and Difficulties Questionnaire, and physical well-being was measured with the KIDSCREEN questionnaire. Structural equation models were constructed with PL and MVPA as predictors of physical well-being and four aspects of psychosocial well-being. RESULTS: A positive moderate association between PL and physical well-being, partly mediated by MVPA was observed. PL was positively associated with the positive aspects of psychosocial well-being and negatively associated with the negative aspects (behaviour problems). None of the associations between PL and aspects of psychosocial well-being were mediated by MVPA. CONCLUSIONS: The study contributes to evidence on the link between PL, physical activity, and health outcomes. The study found beneficial relations between PL and physical and psychosocial well-being. MVPA mediated part of the relationship between PL and physical well-being but not psychosocial well-being.

GRANADA consensus on analytical approaches to assess associations with accelerometer-determined physical behaviours (physical activity, sedentary behaviour and sleep) in epidemiological studies.

The inter-relationship between physical activity, sedentary behaviour and sleep (collectively defined as physical behaviours) is of interest to researchers from different fields. Each of these physical behaviours has been investigated in epidemiological studies, yet their codependency and interactions need to be further explored and accounted for in data analysis. Modern accelerometers capture continuous movement through the day, which presents the challenge of how to best use the richness of these data. In recent years, analytical approaches first applied in other scientific fields have been applied to physical behaviour epidemiology (eg, isotemporal substitution models, compositional data analysis, multivariate pattern analysis, functional data analysis and machine learning). A comprehensive description, discussion, and consensus on the strengths and limitations of these analytical approaches will help researchers decide which approach to use in different situations. In this context, a scientific workshop and meeting were held in Granada to discuss: (1) analytical approaches currently used in the scientific literature on physical behaviour, highlighting strengths and limitations, providing practical recommendations on their use and including a decision tree for assisting researchers' decision-making; and (2) current gaps and future research directions around the analysis and use of accelerometer data. Advances in analytical approaches to accelerometer-determined physical behaviours in epidemiological studies are expected to influence the interpretation of current and future evidence, and ultimately impact on future physical behaviour guidelines.

Associations between objectively measured physical activity, sedentary behaviour and time in bed among 75+ community-dwelling Danish older adults.

BACKGROUND: Older adults are recommended to sleep 7-8 h/day. Time in bed (TIB) differs from sleep duration and includes also the time of lying in bed without sleeping. Long TIB (≥9 h) are associated with self-reported sedentary behavior, but the association between objectively measured physical activity, sedentary behavior and TIB is unknown. METHODS: This study was based on cross-sectional analysis of the Healthy Ageing Network of Competence (HANC Study). Physical activity and sedentary behaviour were measured by a tri-axial accelerometer (ActiGraph) placed on the dominant wrist for 7 days. Sedentary behavior was classified as < 2303 counts per minute (cpm) in vector magnitude and physical activity intensities were categorized, as 2303-4999 and ≥ 5000 cpm in vector magnitude. TIB was recorded in self-reported diaries. Participants were categorized as UTIB (usually having TIB 7-9 h/night: ≥80% of measurement days), STIB (sometimes having TIB 7-9 h/night: 20-79% of measurement days), and RTIB (rarely having TIB 7-9 h/night: < 20% of measurement days). Multinominal regression models were used to calculate the relative risk ratios (RRR) of being RTIB and STIB by daily levels of physical activity and SB, with UTIB as the reference group. The models were adjusted for age, sex, average daily nap length and physical function. RESULTS: Three hundred and fourty-one older adults (median age 81 (IQR 5), 62% women) were included with median TIB of 8 h 21 min (1 h 10 min)/day, physical activity level of 2054 (864) CPM with 64 (15) % of waking hours in sedentary behavior. Those with average CPM within the highest tertile had a lower RRR (0.33 (0.15-0.71), p = 0.005) for being RTIB compared to those within the lowest tertile of average CPM. Accumulating physical activity in intensities 2303-4999 and ≥ 5000 cpm/day did not affect the RRR of being RTIB. RRR of being RTIB among highly sedentary participants (≥10 h/day of sedentary behavior) more than tripled compared to those who were less sedentary (3.21 (1.50-6.88), p = 0.003). CONCLUSIONS: For older adults, being physically active and less sedentary was associated with being in bed for 7-9 h/night for most nights (≥80%). Future longitudinal studies are warranted to explore the causal relationship sbetween physical activity and sleep duration.

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network.

Assessing vital signs such as heart rate (HR) by wearable devices in a lifestyle-related environment provides widespread opportunities for public health related research and applications. Commonly, consumer wearable devices assessing HR are based on photoplethysmography (PPG), where HR is determined by absorption and reflection of emitted light by the blood. However, methodological differences and shortcomings in the validation process hamper the comparability of the validity of various wearable devices assessing HR. Towards Intelligent Health and Well-Being: Network of Physical Activity Assessment (INTERLIVE) is a joint European initiative of six universities and one industrial partner. The consortium was founded in 2019 and strives towards developing best-practice recommendations for evaluating the validity of consumer wearables and smartphones. This expert statement presents a best-practice validation protocol for consumer wearables assessing HR by PPG. The recommendations were developed through the following multi-stage process: (1) a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, (2) an unstructured review of the wider literature pertaining to factors that may introduce bias during the validation of these devices and (3) evidence-informed expert opinions of the INTERLIVE Network. A total of 44 articles were deemed eligible and retrieved through our systematic literature review. Based on these studies, a wider literature review and our evidence-informed expert opinions, we propose a validation framework with standardised recommendations using six domains: considerations for the target population, criterion measure, index measure, testing conditions, data processing and the statistical analysis. As such, this paper presents recommendations to standardise the validity testing and reporting of PPG-based HR wearables used by consumers. Moreover, checklists are provided to guide the validation protocol development and reporting. This will ensure that manufacturers, consumers, healthcare providers and researchers use wearables safely and to its full potential.

Recommendations for determining the validity of consumer wearable and smartphone step count: expert statement and checklist of the INTERLIVE network.

Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, practitioners and researchers are interested in leveraging these devices as a means to track and facilitate PA behavioural change. However, while the acceptance of these devices is increasing, the validity of many consumer devices have not been rigorously and transparently evaluated. The Towards Intelligent Health and Well-Being Network of Physical Activity Assessment (INTERLIVE) is a joint European initiative of six universities and one industrial partner. The consortium was founded in 2019 and strives to develop best-practice recommendations for evaluating the validity of consumer wearables and smartphones. This expert statement presents a best-practice consumer wearable and smartphone step counter validation protocol. A two-step process was used to aggregate data and form a scientific foundation for the development of an optimal and feasible validation protocol: (1) a systematic literature review and (2) additional searches of the wider literature pertaining to factors that may introduce bias during the validation of these devices. The systematic literature review process identified 2897 potential articles, with 85 articles deemed eligible for the final dataset. From the synthesised data, we identified a set of six key domains to be considered during design and reporting of validation studies: target population, criterion measure, index measure, validation conditions, data processing and statistical analysis. Based on these six domains, a set of key variables of interest were identified and a 'basic' and 'advanced' multistage protocol for the validation of consumer wearable and smartphone step counters was developed. The INTERLIVE consortium recommends that the proposed protocol is used when considering the validation of any consumer wearable or smartphone step counter. Checklists have been provided to guide validation protocol development and reporting. The network also provide guidance for future research activities, highlighting the imminent need for the development of feasible alternative 'gold-standard' criterion measures for free-living validation. Adherence to these validation and reporting standards will help ensure methodological and reporting consistency, facilitating comparison between consumer devices. Ultimately, this will ensure that as these devices are integrated into standard medical care, consumers, practitioners, industry and researchers can use this technology safely and to its full potential.

Temporal Alignment of Dual Monitor Accelerometry Recordings.

Combining accelerometry from multiple independent activity monitors worn by the same subject have gained widespread interest with the assessment of physical activity behavior. However, a difference in the real time clock accuracy of the activity monitor introduces a substantial temporal misalignment with long duration recordings which is commonly not considered. In this study, a novel method not requiring human interaction is described for the temporal alignment of triaxial acceleration measured with two independent activity monitors and evaluating the performance with the misalignment manually identified. The method was evaluated with free-living recordings using both combined wrist/hip (n = 9) and thigh/hip device (n = 30) wear locations, and descriptive data on initial offset and accumulated day 7 drift in a large-scale population-based study (n = 2513) were calculated. The results from the Bland-Altman analysis show good agreement between the proposed algorithm and the reference suggesting that the described method is valid for reducing the temporal misalignment and thus reduce the measurement error with aggregated data. Applying the algorithm to the n = 2513 samples worn for 7-days suggest a wide and substantial issue with drift over time when each subject wears two independent activity monitors.

Manual Annotation of Time in Bed Using Free-Living Recordings of Accelerometry Data.

With the emergence of machine learning for the classification of sleep and other human behaviors from accelerometer data, the need for correctly annotated data is higher than ever. We present and evaluate a novel method for the manual annotation of in-bed periods in accelerometer data using the open-source software Audacity®, and we compare the method to the EEG-based sleep monitoring device Zmachine® Insight+ and self-reported sleep diaries. For evaluating the manual annotation method, we calculated the inter- and intra-rater agreement and agreement with Zmachine and sleep diaries using interclass correlation coefficients and Bland-Altman analysis. Our results showed excellent inter- and intra-rater agreement and excellent agreement with Zmachine and sleep diaries. The Bland-Altman limits of agreement were generally around ±30 min for the comparison between the manual annotation and the Zmachine timestamps for the in-bed period. Moreover, the mean bias was minuscule. We conclude that the manual annotation method presented is a viable option for annotating in-bed periods in accelerometer data, which will further qualify datasets without labeling or sleep records.

Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial.

AIMS: To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF). METHODS AND RESULTS: Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6]. CONCLUSION: In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.

Resemblance in accelerometer-assessed physical activity in families with children: the Lolland-Falster Health Study.

BACKGROUND: Evidence of intra-family resemblance in physical activity (PA) is lacking. The association between parent and child PA appears weak, the influence of age and gender on this association is uncertain, and no studies have investigated the degree of resemblance in family members' PA behaviours such as walking, sitting/lying, and biking. Thus, the aims of the study were to examine the degree of resemblance in PA within families, specifically between parents and children, and to explore the size of resemblance across age of children, gender of parents and children, and intensity and type of PA. METHOD: The study is a cross-sectional analysis of a subsample (902 parents and 935 children nested within 605 families) of the Danish population study Lolland-Falster Health Study. PA was measured using a dual-accelerometer system (Axivity AX3) with subsequent processing of time spent in light PA (LPA), moderate-to-vigorous PA (MVPA), and vigorous PA and classification of PA behaviour types. Families with at least one son/daughter aged 0-22 years and one parent providing minimum 4 days of valid accelerometer data were included in the analysis. A linear mixed model regression analysis was used to determine the intraclass correlation coefficient (ICC) of clustering among family members for PA intensities and PA behaviours, adjusted for sex, age, parental education, and the interaction between sex and age. RESULTS: In the analysis of within-family variation in PA, the ICCs across PA intensities and PA behaviours ranged from 0.06 to 0.34. We found stronger clustering in family members' PA for LPA and behaviours requiring low energy expenditure (LPA: ICC 0.22 (95% confidence interval (CI) 0.17; 0.28), sitting/lying: ICC 0.34 (95% CI 0.28; 0.40)), and walking: ICC 0.24 (95% CI 0.19; 0.30) than for higher intensities (e.g. MVPA: ICC 0.07 (95% CI 0.03; 0.14)). The ICC for biking was 0.23 (95% CI 0.18; 0.29). Analyses on parent-child dyads gave similar results. No interaction effects for gender and age (except for biking) were found. CONCLUSION: Parents and children's time spent in PA behaviours requiring low energy expenditure had moderate resemblance within families, whereas engagement in PA with higher intensities showed small or close-to-zero resemblance.

Association between parent and child physical activity: a systematic review.

BACKGROUND: Childhood represents an important life stage for establishment of physical activity (PA) habits. Parents are assumed to play an important role in influencing children's PA. Earlier reviews have mainly focused on parental modelling, encouragement, and support for PA, rather than the actual PA levels of parents. Therefore, the purpose of this review was to systematically summarize the evidence on the relationship between parent and child PA. METHODS: Papers were identified using electronic databases and manual searches of reference lists. Papers reporting on associations between objectively measured child PA and at least one measure of parental PA were included. The quality of the papers was assessed using a modified version of the ROBINS-I tool. For interpretation of the results across studies, we produced albatross plots for all studies combined and by age-groups, sex of the parents, sex of the child, methodology of assessment of parental PA, and type of PA. RESULTS: Thirty-nine papers were included with sample size of parent-child dyads ranging from 15 to 1267 (mean = 319 dyads, median = 227 dyads). The majority of studies were published from 2008 to 2018 and used accelerometry to assess PA. Most of the studies were classified as having moderate, serious, or critical risk of bias. The albatross plot for all studies combined showed that the clear majority of studies observed a positive relationship between parent and child PA. The plot suggested an average magnitude of correlation across studies to be around 0.13, and the overall impression was that this was fairly similar across child age-groups and gender of parent-child dyads. Studies using objective assessment of parental PA showed stronger relationship between parent and child PA compared with studies using self-report (average magnitude of correlation around 0.16 vs 0.04 respectively). No clear evidence was found for the strength of relationship being dependent on type of PA measure of parent and child (total PA, moderate-to-vigorous PA, steps), however, the relationship for light PA appeared weaker. CONCLUSION: This systematic review showed that the clear majority of studies observed a weak positive relationship between parent and child PA regardless of age of the child, the gender of the parent-child dyad, and type of PA. TRIAL REGISTRATION: Registration in PROSPERO: CRD42019093462.