Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.

BACKGROUND: Fall prevention is important for healthy ageing, but the economic impact of fall prevention are scarcely investigated. A recent cost-effectiveness analysis compared a group-delivered Lifestyle-integrated Functional Exercise Program (gLiFE) with an individually-delivered program (LiFE) in community-dwelling people (aged ≥ 70 years) at risk of falling. In addition, the current study aimed to analyze the budget impact of LiFE and gLiFE, compared with standard care in Germany. METHODS: A Markov model was developed to reflect falls and associated care needs for community-dwelling persons over 5 years. The intervention effects of LiFE and gLiFE were shown to be equivalent in a non-inferiority trial, although the costs differed. Outpatient, inpatient, and intervention costs were assessed from a payer's perspective. The effect of parameter uncertainty was assessed in sensitivity analyses. RESULTS: The budget impact due to intervention costs was €510 million for LiFE and €186 million for gLiFE. Over five years, health care expenditures were €35,008 million for those receiving standard care, €35,416 million for those receiving LiFE, and €35,091 million for persons receiving gLiFE. Thereby, LiFE and gLiFE could prevent 2700 deaths and 648,000 falls over 5 years. Parameter uncertainties in the risk of falling, uptake of an intervention offer, and in the intervention effects had a major influence; thus cost savings for LiFE and gLiFE compared with standard care could be achieved for individuals with a high risk of falling. CONCLUSIONS: The results revealed that cost savings for LiFE and gLiFE compared with standard care could only be achieved for individuals at high risk of falling, with gLiFE being superior to LiFE. Future research should consider benefits and aspects of fall prevention beyond falls (e.g., physical activity, social aspects, and personal preferences of participants). TRIAL REGISTRATION: The study was preregistered under underclinicaltrials.gov (identifier: NCT03462654) on 12th March 2018; https://clinicaltrials.gov/ct2/show/NCT03462654 .

Effects of an Exercise Program to Reduce Falls in Older People Living in Long-Term Care: A Randomized Controlled Trial.

OBJECTIVES: To investigate the effect of an exercise program on falls in intermediate and high-level long-term care (LTC) residents and to determine whether adherence, physical capacity, and cognition modified outcomes. DESIGN: Randomized controlled trial. SETTING AND PARTICIPANTS: Residents (n = 520, aged 84 ± 8 years) from 25 LTC facilities in New Zealand. METHODS: Individually randomized to Staying UpRight, a physical therapist-led, balance and strength group exercise program delivered for 1 hour, twice weekly over 12 months. The control arm was dose-matched and used seated activities with no resistance. Falls were collected using routinely collected incident reports. RESULTS: Baseline fall rates were 4.1 and 3.3 falls per person-year (ppy) for intervention and control groups. Fall rates over the trial period were 4.1 and 4.3 falls ppy respectively [P = .89, incidence rate ratio (IRR) 0.98, 95% CI 0.76, 1.27]. Over the 12-month trial period, 74% fell, with 63% of intervention and 61% of the control group falling more than once. Risk of falls (P = .56, hazard ratio 1.08, 95% CI 0.85, 1.36) and repeat falling or fallers sustaining an injury at trial completion were similar between groups. Fall rates per 100 hours walked did not differ between groups (P = .42, IRR 1.15, 95% CI 0.81, 1.63). Program delivery was suspended several times because of COVID-19, reducing average attendance to 26 hours over 12 months. Subgroup analyses of falls outcomes for those with the highest attendance (≥50% of classes), better physical capacity (Short Physical Performance Battery scores ≥8/12), or cognition (Montreal Cognitive Assessment scores ≥ 18/30) showed no significant impact of the program. CONCLUSIONS/IMPLICATIONS: In intermediate and high-level care residents, the Staying UpRight program did not reduce fall rates or risk compared with a control activity, independent of age, sex, or care level. Inadequate exercise dose because of COVID-19-related interruptions to intervention delivery likely contributed to the null result.

User Perspectives of Geriatric German Patients on Smart Sensor Technology in Healthcare.

With consideration of the progressing aging of our societies, the introduction of smart sensor technology can contribute to the improvement of healthcare for older patients and to reductions of the costs of care. From the clinical and medico-ethical points of view, the advantages of smart sensor technology are copious. However, any ethical evaluation of an introduction of a new technology in medical practice requires an inclusion of patients' perspectives and their assessments. We have conducted qualitative, semi-structured, exploratory interviews with 11 older patients in order to gain their subjective opinions on the use of smart sensor devices for rehabilitation purposes. The interviews were analyzed using methods of qualitative content and thematic analyses. In our analysis, we have focused on ethical aspects of adoption of this technology in clinical practice. Most of the interviewees expressed their trust in this technology, foremost because of its accuracy. Several respondents stated apprehension that the use of smart sensors will lead to a change in the patient-healthcare professional relationship. Regarding costs of introduction of smart sensors into healthcare, interviewees were divided between health insurance bearing the costs and individual participation in corresponding costs. Most interviewees had no concerns about the protection of their privacy or personal information. Considering these results, improvement of users' technology literacy regarding possible threats connected with putting smart sensors into clinical practice is a precondition to any individual application of smart sensors. This should occur in the form of extended and well-designed patient information adapted to individual levels of understanding. Moreover, application of smart sensors needs to be accompanied with careful anamnesis of patient's needs, life goals, capabilities, and concerns.

Evaluating the Effect of Activity and Environment on Fall Risk in a Paradigm-Depending Laboratory Setting: Protocol for an Experimental Pilot Study.

BACKGROUND: Knowledge about the causal factors leading to falls is still limited, and fall prevention interventions urgently need to be more effective to limit the otherwise increasing burden caused by falls in older people. To identify individual fall risk, it is important to understand the complex interplay of fall-related factors. Although fall events are common, they are seldom observed, and fall reports are often biased. Due to the rapid development of wearable inertial sensors, an objective approach to capture fall events and the corresponding circumstances is provided. OBJECTIVE: The aim of this work is to operationalize a prototypical dynamic fall risk model regarding 4 ecologically valid real-world scenarios (opening a door, slipping, tripping, and usage of public transportation). We hypothesize that individual fall risk is associated with an interplay of intrinsic risk factors, activity, and environmental factors that can be estimated by using data measured within a laboratory simulation setting. METHODS: We will recruit 30 community-dwelling people aged 60 years or older. To identify several fall-related intrinsic fall risk factors, appropriate clinical assessments will be selected. The experimental setup is adaptable so that the level of fall risk for each activity and each environmental factor is adjustable. By different levels of difficulty, the effect on the risk of falling will be investigated. An 8-camera motion tracking system will be used to record absolute body motions and limits of stability. All laboratory experiments will also be recorded by inertial sensors (L5, dominant leg) and video camera. Logistic regression analyses will be used to model the association between risk factors and falls. Continuous fall risk will be modeled by generalized linear regression models using margin of stability as outcome parameter. RESULTS: The results of this project will prove the concept and establish methods to further use the dynamic fall risk model. Recruitment and measurement initially began in October 2020 but were halted because of the COVID-19 pandemic. Recruitment and measurements recommenced in October 2022, and by February 2023, a total of 25 of the planned 30 subjects have been measured. CONCLUSIONS: In the field of fall prevention, a more precise fall risk model will have a significant impact on research leading to more effective prevention approaches. Given the described burden related to falls and the high prevalence, considerable improvements in fall prevention will have a significant impact on individual quality of life and also on society in general by reducing institutionalization and health care costs. The setup will enable the analysis of fall events and their circumstances ecologically valid in a laboratory setting and thereby will provide important information to estimate the individual instantaneous fall risk. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46930.

Effect of a Passive Exosuit on Sit-to-Stand Performance in Geriatric Patients Measured by Body-Worn Sensors-A Pilot Study.

Standing up from a seated position is a prerequisite for any kind of physical mobility but many older persons have problems with the sit-to-stand (STS) transfer. There are several exosuits available for industrial work, which might be adapted to the needs of older persons to support STS transfers. However, objective measures to quantify and evaluate such systems are needed. The aim of this study was to quantify the possible support of an exosuit during the STS transfer of geriatric patients. Twenty-one geriatric patients with a median age of 82 years (1.-3.Q. 79-84 years) stood up at a normal pace (1) from a chair without using armrests, (2) with using armrests and (3) from a bed with pushing off, each condition with and without wearing an exosuit. Peak angular velocity of the thighs was measured by body-worn sensors. It was higher when standing up with exosuit support from a bed (92.6 (1.-3.Q. 84.3-116.2)°/s versus 79.7 (1.-3.Q. 74.6-98.2)°/s; p = 0.014) and from a chair with armrests (92.9 (1.-3.Q. 78.3-113.0)°/s versus 77.8 (1.-3.Q. 59.3-100.7)°/s; p = 0.089) compared to no support. There was no effect of the exosuit when standing up from a chair without using armrests. In general, it was possible to quantify the support of the exosuit using sensor-measured peak angular velocity. These results suggest that depending on the STS condition, an exosuit can support older persons during the STS transfer.

Comparison of falls and cost-effectiveness of the group versus individually delivered Lifestyle-integrated Functional Exercise (LiFE) program: final results from the LiFE-is-LiFE non-inferiority trial.

BACKGROUND: the individually delivered Lifestyle-integrated Functional Exercise (LiFE) was shown to improve physical activity (PA) and reduce fall incidence, however being rather resource-consuming due to one-to-one delivery. A potentially less resource-intensive group format (gLiFE) was developed and compared against the original program, considering higher risk of falling due to possible PA enhancement. OBJECTIVE: to investigate non-inferiority in terms of PA-adjusted fall risk and cost-effectiveness of gLiFE at 12-month follow-up. DESIGN: single-blinded, randomised, multi-centre non-inferiority trial. SETTING: community. SUBJECTS: in total, 309 adults aged 70+ years at risk of or with history of falling; n = 153 in gLiFE, n = 156 in LiFE. METHODS: LiFE was delivered one-to-one at the participants' homes, gLiFE in a group. PA-adjusted fall risk was analysed using negative binomial regression to compare incidence rate ratios (IRR). Cost-effectiveness was presented by incremental cost-effectiveness ratios and cost-effectiveness acceptability curves, considering quality-adjusted life years, PA and falls as effect measures. Secondary analyses included PA (steps/day) and fall outcomes. RESULTS: non-inferiority was inconclusive (IRR 0.96; 95% confidence interval, CI 0.67; 1.37); intervention costs were lower for gLiFE, but cost-effectiveness was uncertain. gLiFE participants significantly increased PA (+1,090 steps/day; 95% CI 345 and 1.835) versus insignificant increase in LiFE (+569, 95% CI -31; 1,168). Number of falls and fallers were reduced in both formats. CONCLUSION: non-inferiority of gLiFE compared with LiFE was inconclusive after 12 months. Increases in PA were clinically relevant in both groups, although nearly twice as high in gLiFE. Despite lower intervention costs of gLiFE, it was not clearly superior in terms of cost-effectiveness.

Reference equations for harmonizing gait speed results of different test protocols in community-dwelling older adults.

BACKGROUND AND AIMS: Different gait speed assessment protocols regarding start and stop of walking make comparison between studies impossible. The aim of this study was providing reference equations to estimate a person´s steady-state gait speed from gait speed measured with a test protocol including static start and/or stop. METHODS: Gait speed of 150 community-dwelling older adults (mean age 80.5 ± 4.5 years; 61% women) was measured over 4 m with different assessment protocols regarding start and stop of walking on an instrumented walkway. Reference equations to estimate steady-state gait speed from the results of other test protocols were calculated by regression analysis within a fivefold cross-validation. RESULTS: Mean absolute errors and the root mean squared errors of all reference equations ranged from 0.063 m/s to 0.074 m/s and 0.082 m/s to 0.096 m/s, respectively. CONCLUSIONS: The provided reference equations can help harmonizing results between studies in community-dwelling older adults.

Changes in Psychological Determinants of Behavior Change after Individual versus Group-Based Lifestyle-integrated Fall Prevention: Results from the LiFE-is-LiFE Trial.

OBJECTIVE: The Lifestyle-integrated Functional Exercise (LiFE) intervention has been shown to promote physical activity in fall-prone older adults. However, the underlying mechanisms of how LiFE functions remain unclear. This study compares the effects of the individual and group-based LiFE formats on psychological determinants of behavior change derived from the health action process approach, habit formation theory, and self-determination theory. METHODS: Secondary analysis on basis of the randomized, non-inferiority LiFE-is-LiFE trial were performed. Questionnaire data on psychological determinants were obtained from older adults (M = 78.8 years, range 70-95) who took part in either the individual (n = 156) or the group-based (n = 153) LiFE intervention. Measurement points varied from three to six times, and from baseline (T1) up to a 12-month follow-up (T6). A generalized linear mixed model was specified for each determinant. RESULTS: Both LiFE and gLiFE participants reported lower levels of motivational determinants at T6. LiFE participants showed significantly higher values of action planning and coping planning at T6. Participants in both formats showed increased levels of action control at T6, whereas participants' habit strength decreased post-intervention but then stabilized over time. LiFE participants showed higher levels of autonomy, competence, and relatedness throughout the study, but levels of intrinsic motivation did not differ between formats and from T1 to T6. CONCLUSION: In both formats, but especially in the individual LiFE, the behavior change techniques used affected volitional rather than motivational or general determinants of behavior change. Habit strength as an important indicator of the sustainability of the LiFE exercises stabilized over time, indicating that participants, at least partly, sustained their formed habits long-term.

The value of walking: a systematic review on mobility and healthcare costs.

BACKGROUND: The ability to walk is an important indicator of general health and mobility deficits have wide-ranging economic implications. We undertook a systematic review to elucidate the impact of walking parameters on health care costs.  METHODS: Publications reporting on associations between health care costs and walking parameters were identified by a systematic literature search in MEDLINE, Embase, and manual reference screening, following the PRISMA reporting guidelines. First, titles and abstracts were screened by two independent reviewers followed by a review of the full articles if they met the inclusion criteria. Costs were converted to US-Dollars with inflation adjustment for 2021. A narrative synthesis was performed.  RESULTS: Ten studies conducted between 2001 and 2021 fulfilled the inclusion criteria. Assessment of walking ability was carried out via patient reported outcomes, performance tests, or using wearable digital devices. Walking more than one hour per day, a faster walking speed and the ability to walk without impairments are associated with significant lower health care costs. A higher number of steps per day is associated with significant lower costs in two simulation studies, while in the study using a digital device, taking more than 10,000 steps per day is not significantly associated with lower direct costs. The heterogeneity of mobility assessments and of economic analyses both precluded a quantitative synthesis. CONCLUSION: Cross-sectional and observational studies from this systematic review suggest a significant association of better walking performance with lower health care costs. Future health economic research and health technology assessments should use quantifiable mobility outcomes when evaluating new drugs or non-pharmacological interventions.

Unlocking the black box of geriatric physiotherapy : Quantification of physical activity and walking parameters during inpatient geriatric rehabilitation therapy sessions.

BACKGROUND: Physiotherapy and occupational therapy are currently described using the duration of treatment (days or weeks), the frequency of therapy sessions (on a daily or 3-5 days per week basis) and considering the duration of a session (e.g., 30 or 45 min). The content is often poorly defined and the intensity is rarely reported. Using digital technology some of these shortcomings can be overcome. The cumulative parameters of walking and activity sessions, the duration of walking, the time spent in an upright or lying/sitting position and the number of steps can now be analyzed. In this study, we examined the parameters during non-treatment periods and therapy time in patients recovering from fragility fractures. METHODS: The study is a secondary data analysis of a trial that examined the improvement of physical activity (PA) and self-efficacy of fragility fracture patients. Changes in mobility parameters were measured using the ActivPal3 sensor during the 1st and 3rd weeks of rehabilitation and 104 patients were analyzed (mean age 82.5 years). Parameters included the time during supervised treatment, the mean number of steps, cumulative time in an upright position and walking duration, the number of walking intervals of > 10 s and sit to stand transfers. RESULTS: Patients received 3-4 therapy sessions adding up to 90-120 min per day. More than 50% of the daily walking activities were achieved in these sessions until discharge. With this amount of therapeutic input most parameters meaningfully improved from baseline to the second measurement. The number of steps increased by 30%, the mean time in an upright position increased by 26% and the mean time spent walking increased by 49%. CONCLUSION: The sensor-derived measurements describe the amount of walking activity administered during the supervised therapy sessions. This could be used as a starting point for future trials to improve the outcomes or as a standard of process evaluation for clinical services.

Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective.

BACKGROUND: Perceived benefits of intervention programs from a participant perspective can be examined by assessing their willingness to pay (WTP). Aiming to support decision-makers in their decision to implement a fall prevention program, this study examined (1) the WTP for a group-based and an individually delivered fall prevention program, (2) which factors influence WTP, and (3) whether the WTP exceeds the intervention costs. METHODS: WTP was elicited using Payment Cards from 237 individuals who participated in a randomized non-inferiority trial (LiFE-is-LiFE) comparing a group version of the Lifestyle-integrated Functional Exercise program (gLiFE) with the individually delivered version (LiFE). Linear regression models were used to examine factors associated with WTP. The net benefit for (g)LiFE was calculated as the difference between WTP and intervention costs, assuming different scenarios of intervention costs (varying group sizes of gLiFE) and hypothetical subsidy levels by a payer (€0, €50, or €75). RESULTS: The mean WTP was €196 (95% CI [172, 221]) for gLiFE and €228 (95% CI [204, 251]) for LiFE. In the linear regression model, WTP was significantly associated with delivery format (-€32, 95% CI [- 65, - 0.2], for gLiFE) and net household income (+ 68€, 95% CI [23, 113], for ≥€3000 compared to <€2000). The net benefit for gLiFE was positive in most cases. Due to higher intervention costs of LiFE compared to gLiFE (€298 vs. €113), the net benefit for LiFE was negative for the majority of the sample, even at a subsidy of €75. CONCLUSION: The results provide insight into how valuable the interventions are perceived by the participants and thereby may be used by decision-makers as complement to cost-effectiveness analyses. WTP for both programs was generally high, probably indicating that participants perceived the intervention as quite valuable. However, further research is needed on the WTP and net benefit of fall prevention programs, as results relied on the specific context of the LiFE-is-LiFE trial.

Group-Based and Individually Delivered LiFE: Content Evaluation and Predictors of Training Response - A Dose-Response Analysis.

Introduction: Lifestyle-integrated Functional Exercise (LiFE) is an effective, individually delivered fall prevention program but comes with substantial resource requirements; hence, a group-format was developed (gLiFE). This study 1) evaluates the program content of two different LiFE formats (group vs individual) and 2) examines the relationship between predictors of training response (dose) and improvements in balance, strength, and physical activity (PA) (response). Material and Methods: The analysis included n = 252 (gLiFE = 126, LiFE = 126) community-dwelling older adults (78.6±5.2 years). LiFE was administered in seven sessions either in a group (gLiFE: 8-12 participants) or individually at home (LiFE). Questionnaire-based, descriptive content evaluation (frequency distributions) included reported frequency of practice (days/week, number of activities), activity preferences, safety, intensity, integrability of activities, and acceptance after 6 months of LiFE practice. Predictors (ie, dose [reported frequency and intensity], safety, and integrability of activities) for improvements in balance, strength, and PA were analyzed using radar charts. Results: In both formats, 11.2 activities were practiced on average. Strength activities were more frequently selected than balance. Content evaluation showed some marginal advantages for the LiFE participants for selected aspects. The effects on balance, strength, and PA were nearly similar in both groups. Participants who performed balance activities more frequently (≥4 days/week) scored better in the balance and PA domain. Those who performed strength activities more frequently (≥4 days/week) performed better in all three outcomes. Higher perceived safety was associated with better performance. Those who reported activities as "not physically exhausting" performed better in all three outcomes. Those who found activities easily integrable into daily routines scored higher in the balance and strength domain. Discussion and Conclusion: Overall, both program formats are comparable with respect to content evaluation and effects. Participants need to perceive the activities as safe, not exhausting, and should practice ≥4 days/week to generate a high benefit from the intervention. Trial Registration: ClinicalTrials.gov, NCT03462654. Registered on 12 March 2018.

Daily steps and all-cause mortality: a meta-analysis of 15 international cohorts.

BACKGROUND: Although 10 000 steps per day is widely promoted to have health benefits, there is little evidence to support this recommendation. We aimed to determine the association between number of steps per day and stepping rate with all-cause mortality. METHODS: In this meta-analysis, we identified studies investigating the effect of daily step count on all-cause mortality in adults (aged ≥18 years), via a previously published systematic review and expert knowledge of the field. We asked participating study investigators to process their participant-level data following a standardised protocol. The primary outcome was all-cause mortality collected from death certificates and country registries. We analysed the dose-response association of steps per day and stepping rate with all-cause mortality. We did Cox proportional hazards regression analyses using study-specific quartiles of steps per day and calculated hazard ratios (HRs) with inverse-variance weighted random effects models. FINDINGS: We identified 15 studies, of which seven were published and eight were unpublished, with study start dates between 1999 and 2018. The total sample included 47 471 adults, among whom there were 3013 deaths (10·1 per 1000 participant-years) over a median follow-up of 7·1 years ([IQR 4·3-9·9]; total sum of follow-up across studies was 297 837 person-years). Quartile median steps per day were 3553 for quartile 1, 5801 for quartile 2, 7842 for quartile 3, and 10 901 for quartile 4. Compared with the lowest quartile, the adjusted HR for all-cause mortality was 0·60 (95% CI 0·51-0·71) for quartile 2, 0·55 (0·49-0·62) for quartile 3, and 0·47 (0·39-0·57) for quartile 4. Restricted cubic splines showed progressively decreasing risk of mortality among adults aged 60 years and older with increasing number of steps per day until 6000-8000 steps per day and among adults younger than 60 years until 8000-10 000 steps per day. Adjusting for number of steps per day, comparing quartile 1 with quartile 4, the association between higher stepping rates and mortality was attenuated but remained significant for a peak of 30 min (HR 0·67 [95% CI 0·56-0·83]) and a peak of 60 min (0·67 [0·50-0·90]), but not significant for time (min per day) spent walking at 40 steps per min or faster (1·12 [0·96-1·32]) and 100 steps per min or faster (0·86 [0·58-1·28]). INTERPRETATION: Taking more steps per day was associated with a progressively lower risk of all-cause mortality, up to a level that varied by age. The findings from this meta-analysis can be used to inform step guidelines for public health promotion of physical activity. FUNDING: US Centers for Disease Control and Prevention.

Assessment of Thigh Angular Velocity by an Activity Monitor to Describe Sit-to-Stand Performance.

The assessment of sit-to-stand (STS) performance is highly relevant, especially in older persons, but testing STS performance in the laboratory does not necessarily reflect STS performance in daily life. Therefore, the aim was to validate a wearable sensor-based measure to be used under unsupervised daily life conditions. Since thigh orientation from horizontal to vertical is characteristic for STS movement, peak angular velocity (PAV) of the thigh was chosen as the outcome variable. A total of 20 younger and older healthy persons and geriatric patients (mean age: 55.5 ± 20.8 years; 55% women) with a wide range of STS performance were instructed to stand up from a chair at their usual pace. STS performance was measured by an activity monitor, force plates, and an opto-electronic system. The association between PAV measured by the thigh-worn activity monitor and PAV measured by the opto-electronic system (gold standard) was r = 0.74. The association between PAV measured by the thigh-worn activity monitor and peak power measured by force plate and opto-electronic system was r = 0.76. The Intra-Class Coefficient (ICC) of agreement between the 2 trials was ICC(A,1) = 0.76. In this sample of persons with a wide range of physical performance, PAV as measured by a thigh-worn acceleration sensor was a valid and reliable measure of STS performance.

The relationship of weather with daily physical activity and the time spent out of home in older adults from Germany - the ActiFE study.

BACKGROUND: There is a need for a comprehensive evaluation of the associations between varieties of weather conditions on the time spent out-of-home (TOH) and on walking duration (WD) among older adults. We aim to investigate the extent to which various weather parameters (temperature, solar radiation, sunshine duration, humidity, windspeed, and rain) determine daily WD the TOH in older adults. METHODS: The ActiFE (Activity and Function in Older People in Ulm) study is a prospective study of participants aged 65 years or older who wore an accelerometer and kept a movement diary in up to three temporally separated waves from 2009 to 2018 for a duration up to seven days per wave (up to three weeks in summary). We used weather data from a weather station near the participants' homes. Age-adjusted and gender-stratified generalized mixed models were used to predict WD and TOH (with 95% confidence interval (CI)) within and between weather categories. Generalized additive models were computed for the single predictions at the weather quartile boundaries. Cubic splines (with 95% pointwise confidence bands (CB)) visualized the continuous course of the weather values. RESULTS: Higher temperatures, solar radiation and more hours of sunshine, led to an increase in WD and TOH, while higher precipitation, humidities and windspeeds led to a decrease. Women had in general higher WD and TOH times than men. CONCLUSIONS: Our data suggest that weather parameters have a considerable influence on PA and TOH. Future analyses and interpretation of PA data should therefore account for weather parameters.

Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?

BACKGROUND: Mobility is defined as the ability to independently move around the environment and is a key contributor to quality of life, especially in older age. The aim of this study was to evaluate the use of mobility as a decisive outcome for the marketing authorisation of drugs by the European Medicines Agency (EMA). METHODS: Fifteen therapeutic areas which commonly lead to relevant mobility impairments and alter the quantity and/or the quality of walking were selected: two systemic neurological diseases, four conditions primarily affecting exercise capacity, seven musculoskeletal diseases and two conditions representing sensory impairments. European Public Assessment Reports (EPARs) published by the EMA until September 2020 were examined for mobility endpoints included in their 'main studies'. Clinical study registries and primary scientific publications for these studies were also reviewed. RESULTS: Four hundred and eighty-four EPARs yielded 186 relevant documents with 402 'main studies'. The EPARs reported 153 primary and 584 secondary endpoints which considered mobility; 70 different assessment tools (38 patient-reported outcomes, 13 clinician-reported outcomes, 8 performance outcomes and 13 composite endpoints) were used. Only 15.7% of those tools distinctly informed on patients' mobility status. Out of 402, 105 (26.1%) of the 'main studies' did not have any mobility assessment. Furthermore, none of these studies included a digital mobility outcome. CONCLUSIONS: For conditions with a high impact on mobility, mobility assessment was given little consideration in the marketing authorisation of drugs by the EMA. Where mobility impairment was considered to be a relevant outcome, questionnaires or composite scores susceptible to reporting biases were predominantly used.

Cost-Effectiveness of a Group vs Individually Delivered Exercise Program in Community-Dwelling Persons Aged ≥70 Years.

OBJECTIVES: Interventions aimed at reducing falls and physical inactivity could alleviate the economic burden attributable to these factors. The study aimed to analyze the cost-effectiveness of a group-delivered version of the Lifestyle-integrated Functional Exercise Program compared with an individually delivered program version. DESIGN: An economic evaluation conducted alongside the LiFE-is-LiFE randomized non-inferiority trial. INTERVENTIONS: Group and individually delivered version of a program consisting of strength and balance exercises integrated into everyday activities to prevent falls. SETTING AND PARTICIPANTS: 309 community-dwelling older adults (aged ≥70 years) at risk of falling recruited around Heidelberg and Stuttgart (Germany). METHODS: Cost-effectiveness of the group program was assessed over 6 months using different effect measures [quality-adjusted life years (QALYs, EQ-5D-5L), physical activity (mean number of steps/day), and falls] and cost perspectives (societal and payer's). Incremental cost-effectiveness ratios were determined, and cost-effectiveness acceptability curves were constructed. RESULTS: From a societal perspective, mean costs, the number of falls, and the number of steps/day were somewhat higher in the group program, whereas QALYs were almost identical between the 2 interventions. From the payer's perspective, the incremental cost-effectiveness ratio for the group compared to the individual program were €56,733 per QALY and €4755 per fall prevented. Based on the cost-effectiveness acceptability curves, the cost-effectiveness of the group program had to be rated as uncertain for both effect measures and perspectives. In contrast, it demonstrated cost-effectiveness for increasing physical activity at willingness-to-pay values per additional 1000 steps/day of €1600 (societal perspective) or €600 (payer's perspective). CONCLUSIONS AND IMPLICATIONS: Compared to the individual program, the group program might be cost-effective for increasing physical activity in older adults but was unlikely to be cost-effective with regard to QALY or for preventing falls. The cost-effectiveness should be evaluated long-term and compared to a regular care group.

Lifestyle-integrated functional exercise to prevent falls and promote physical activity: Results from the LiFE-is-LiFE randomized non-inferiority trial.

BACKGROUND: The 'Lifestyle-integrated Functional Exercise' (LiFE) program successfully reduced risk of falling via improvements in balance and strength, additionally increasing physical activity (PA) in older adults. Generally being delivered in an individual one-to-one format, downsides of LiFE are considerable human resources and costs which hamper large scale implementability. To address this, a group format (gLiFE) was developed and analyzed for its non-inferiority compared to LiFE in reducing activity-adjusted fall incidence and intervention costs. In addition, PA and further secondary outcomes were evaluated. METHODS: Older adults (70 + years) at risk of falling were included in this multi-center, single-blinded, randomized non-inferiority trial. Balance and strength activities and means to enhance PA were delivered in seven intervention sessions, either in a group (gLiFE) or individually at the participant's home (LiFE), followed by two "booster" phone calls. Negative binomial regression was used to analyze non-inferiority of gLiFE compared to LiFE at 6-month follow-up; interventions costs were compared descriptively; secondary outcomes were analyzed using generalized linear models. Analyses were carried out per protocol and intention-to-treat. RESULTS: Three hundred nine persons were randomized into gLiFE (n = 153) and LiFE (n = 156). Non-inferiority of the incidence rate ratio of gLiFE was inconclusive after 6 months according to per protocol (mean = 1.27; 95% CI: 0.80; 2.03) and intention-to-treat analysis (mean = 1.18; 95% CI: 0.75; 1.84). Intervention costs were lower for gLiFE compared to LiFE (-€121 under study conditions; -€212€ under "real world" assumption). Falls were reduced between baseline and follow-up in both groups (gLiFE: -37%; LiFE: -55%); increases in PA were significantly higher in gLiFE (+ 880 steps; 95% CI 252; 1,509). Differences in other secondary outcomes were insignificant. CONCLUSIONS: Although non-inferiority of gLiFE was inconclusive, gLiFE constitutes a less costly alternative to LiFE and it comes with a significantly larger enhancement of daily PA. The fact that no significant differences were found in any secondary outcome underlines that gLiFE addresses functional outcomes to a comparable degree as LiFE. Advantages of both formats should be evaluated in the light of individual needs and preferences before recommending either format. TRIAL REGISTRATION: The study was preregistered under clinicaltrials.gov (identifier: NCT03462654 ) on March 12th 2018.

Change of physical activity parameters of hip and pelvic fracture patients during inpatient rehabilitation and after discharge: analysis of global and in-depth parameters.

BACKGROUND: A growing number of older adults suffer hip and pelvic fractures leading to hospital admission. They often result in reduced physical activity (PA) and impaired mobility. PA can be objectively measured with body-worn sensors. Usually, global cumulative PA parameters are analysed, such as walking duration, upright-time and number of steps. These traditional parameters mix different domains of PA, such as physical capacity (PC), behaviour and living environment. We examined the change of global cumulative PA measures during rehabilitation and after discharge in patients with hip or pelvic fracture and whether more 'in-depth' PA parameters, such as walking interval length, variability of interval length and sit-to-stand transitions and their changes during rehabilitation and 3 months after discharge might better reflect the above mentioned three clinically relevant domains of PA. METHODS: This study is a secondary data analysis of a randomised controlled trial to improve PA and fall-related self-efficacy in hip or pelvic fracture patients (≥60 years) with concerns about falling. Changes of accelerometer-measured global cumulative and in-depth PA parameters (activPAL3) were analysed in an observational design before and after discharge combining both groups. For comparison, the same analyses were applied to the traditional PC measures gait speed and 5-chair-rise. RESULTS: Seventy-five percent of the 111 study participants were female (mean age: 82.5 (SD = 6.76) years. Daily walking duration, upright time and number of steps as aspects of global PA increased during inpatient rehabilitation as well as afterwards. The in-depth PA parameters showed differing patterns. While the total number of walking bouts increased similarly, the number of longer walking bouts decreased by 50% after discharge. This pattern was also seen for the average walking interval length, which increased by 2.34 s (95% confidence interval (CI): 0.68; 4.00) during inpatient rehabilitation and decreased afterwards below baseline level (- 4.19 s (95% CI: - 5.56; - 2.82)). The traditional PC measures showed similar patterns to the in-depth PA parameters with improvements during rehabilitation, but not at home. CONCLUSION: Our findings suggest that the in-depth PA parameters add further information to the global cumulative PA parameters. Whereas global cumulative PA parameters improved significantly during inpatient rehabilitation and after discharge, in-depth PA parameters as well as PC did not continuously improve at home. In contrast to global cumulative PA parameters the in-depth parameters seem to reflect contextual factors such as the build environment and aspects of PC, which are traditionally assessed by clinical PC measures. These in combination with digital mobility measures can help clinicians to assess the health status of fragility fracture patients, individually tailor therapy measures and monitor the rehabilitation process.

Template-Based Recognition of Human Locomotion in IMU Sensor Data Using Dynamic Time Warping.

Increased levels of light, moderate and vigorous physical activity (PA) are positively associated with health benefits. Therefore, sensor-based human activity recognition can identify different types and levels of PA. In this paper, we propose a two-layer locomotion recognition method using dynamic time warping applied to inertial sensor data. Based on a video-validated dataset (ADAPT), which included inertial sensor data recorded at the lower back (L5 position) during an unsupervised task-based free-living protocol, the recognition algorithm was developed, validated and tested. As a first step, we focused on the identification of locomotion activities walking, ascending and descending stairs. These activities are difficult to differentiate due to a high similarity. The results showed that walking could be recognized with a sensitivity of 88% and a specificity of 89%. Specificity for stair climbing was higher compared to walking, but sensitivity was noticeably decreased. In most cases of misclassification, stair climbing was falsely detected as walking, with only 0.2-5% not assigned to any of the chosen types of locomotion. Our results demonstrate a promising approach to recognize and differentiate human locomotion within a variety of daily activities.