Adherence to mHealth and Paper-Based Versions of Lifestyle-Integrated Functional Exercise: A Secondary Analysis of Data From the PreventIT Feasibility Randomized Controlled Trial.

The European Commission Horizon 2020 project-PreventIT-evaluated two approaches to delivering Lifestyle-Integrated Functional Exercise (LiFE) programs for maintaining older adults' physical function: the paper-based adapted LiFE and mobile health device delivered enhanced LiFE. A self-reported method was used to measure users' monthly adherence over 12 months. This analysis aimed to explore young seniors' adherence patterns between enhanced LiFE and adapted LiFE groups. Results showed that adherence level decreased with time in both groups. The enhanced LiFE group had slightly higher adherence than the adapted LiFE group during most of the 12 months. However, the overall adherence levels were not significantly different during either intervention or follow-up periods. Monthly self-reported adherence measurement can help to understand users' adherence comprehensively. The comparable adherence levels between both groups indicate mobile health could be an alternative to delivering home-based physical activity for young seniors. However, this feasibility study was not powered to detect differences between groups.

Linking health service utilisation and mortality data-unravelling what happens after fall-related paramedic care.

BACKGROUND: A randomised controlled trial implemented and evaluated a new model of care for non-transported older fallers to prevent future falls and unplanned health service use. This current study uses linked data to evaluate the effects of the intervention beyond the initial 12-month study period. METHOD: Study data from an established cohort of 221 adults were linked to administrative data from NSW Ambulance, Emergency Department Data Collection, Admitted Patient Data Collection and Registry of Births, Deaths and Marriages evaluating health service use at 12, 24 and 36 months following randomisation including time to event (health service utilisation) and mortality. Negative binomial and Cox's proportional hazard regression were performed to capture the impact of the study between groups and adherence status. RESULTS: At 36 months follow-up, 89% of participants called an ambulance, 87% attended the Emergency Department and 91% were admitted to hospital. There were no significant differences in all-cause health service utilisation between the control and intervention group (IG) at 12, 24 and 36 months follow-up. Fall-related health service use was significantly higher within the IG at 12 (IRR:1.40 (95%CI:1.01-1.94) and 24 months (IRR:1.43 (95%CI:1.05-1.95)). Medication use, impaired balance and previous falls were associated with subsequent health service use. Over 40% of participants died by the follow-up period with risk of death lower in the IG at 36 months (HR:0.64, 95%CI:0.45-0.91). CONCLUSION: Non-transported fallers have a high risk of future health service use for fall and other medical-related reasons. Interventions which address this risk need to be further explored.

Sensitivity to Change and Responsiveness of the Original and the Shortened Version of the Community Balance and Mobility Scale for Young Seniors.

OBJECTIVE: To examine sensitivity to change and responsiveness of the Community Balance and Mobility Scale (CBM) and shortened CBM (s-CBM). DESIGN: Secondary analysis using data of a randomized controlled trial. SETTING: General community. PARTICIPANTS: Young community-dwelling seniors aged 61-70 years (N=134; mean age, 66.2±2.5y). INTERVENTIONS: Participants underwent 12 months of exercise intervention. MAIN OUTCOME MEASURES: CBM and s-CBM. Sensitivity to change was assessed using standardized response mean (SRM) and paired t tests as appropriate. Responsiveness was assessed using 2 minimal important difference (MID) estimates. Analyses were conducted for the full sample and for the subgroups "high-balance" and "low-balance," divided by median split. RESULTS: Inferential statistics revealed a significant CBM (P<.001) and s-CBM (P<.001) improvement within the full sample and the subgroups (high-balance: P=.001, P=.019; low-balance: P<.001, P<.001). CBM and s-CBM were moderately sensitive to change (SRM, 0.48 vs 0.38) within the full sample. In the high-balance subgroup, moderate SRM values (0.70) were found for the CBM and small values for the s-CBM (0.29). In the low-balance subgroup, moderate SRM values were found for the CBM (0.67) and high values for the s-CBM (0.80). For the full sample, CBM and s-CBM exceeded the lower but not the higher MID value. In the high-balance subgroup, the CBM exceeded both MID values, but the s-CBM exceeded only the lower. In the low-balance subgroup, CBM and s-CBM exceeded both MID values. CONCLUSIONS: The CBM is a suitable tool to detect intervention-related changes of balance and mobility in young, high-performing seniors. Both versions of the CBM scale show good sensitivity to change and responsiveness, particularly in young seniors with low balance.

Impact of the backward chaining method on physical and psychological outcome measures in older adults at risk of falling: a systematic review.

BACKGROUND: Being unable to "get up from the floor" is a risk factor and predictor of serious fall-related injuries in older age; however, floor-rise training (FRT) is not widely used. The backward chaining method (BCM) is a success-oriented, step-by-step form of FRT. This systematic review aimed to evaluate the impact of BCM on physical and psychological outcome measures, and its clinical application. METHODS: Studies were identified through systematic searching of five databases. Criteria for inclusion were: use of BCM as a treatment method, outcome measures related to falls, and participants aged 60 + years. Study quality was evaluated using the Mixed Methods Appraisal Tool and PEDro scale, if applicable. RESULTS: Seven studies with a total of 446 participants (mean age 82.4 ± 5.3 years) were identified. Emerging evidence shows that BCM significantly improves the ability to get up unassisted from the floor, as well as mobility with reduced fall incidence in older people. Furthermore, it can potentially reduce fear of falling. Reporting on feasibility and acceptance of BCM was limited. Study quality varied widely. CONCLUSIONS: BCM provides a promising intervention in fall-related recovery strategies for older adults and is most effective when offered to older adults at risk of falling. Considering the small number of included studies and the varying methodological quality, these findings should be evaluated accordingly. The growing evidence regarding the benefits of BCM, yet the lack of adoption into standard care, highlights the need for further research and clinical application of this intervention approach.

Predicting Advanced Balance Ability and Mobility with an Instrumented Timed Up and Go Test.

Extensive test batteries are often needed to obtain a comprehensive picture of a person's functional status. Many test batteries are not suitable for active and healthy adults due to ceiling effects, or require a lot of space, time, and training. The Community Balance and Mobility Scale (CBMS) is considered a gold standard for this population, but the test is complex, as well as time- and resource intensive. There is a strong need for a faster, yet sensitive and robust test of physical function in seniors. We sought to investigate whether an instrumented Timed Up and Go (iTUG) could predict the CBMS score in 60 outpatients and healthy community-dwelling seniors, where features of the iTUG were predictive, and how the prediction of CBMS with the iTUG compared to standard clinical tests. A partial least squares regression analysis was used to identify latent components explaining variation in CBMS total score. The model with iTUG features was able to predict the CBMS total score with an accuracy of 85.2% (84.9-85.5%), while standard clinical tests predicted 82.5% (82.2-82.8%) of the score. These findings suggest that a fast and easily administered iTUG could be used to predict CBMS score, providing a valuable tool for research and clinical care.

Comparison of Standard Clinical and Instrumented Physical Performance Tests in Discriminating Functional Status of High-Functioning People Aged 61⁻70 Years Old.

Assessment of physical performance by standard clinical tests such as the 30-sec Chair Stand (30CST) and the Timed Up and Go (TUG) may allow early detection of functional decline, even in high-functioning populations, and facilitate preventive interventions. Inertial sensors are emerging to obtain instrumented measures that can provide subtle details regarding the quality of the movement while performing such tests. We compared standard clinical with instrumented measures of physical performance in their ability to distinguish between high and very high functional status, stratified by the Late-Life Function and Disability Instrument (LLFDI). We assessed 160 participants from the PreventIT study (66.3 ± 2.4 years, 87 females, median LLFDI 72.31, range: 44.33⁻100) performing the 30CST and TUG while a smartphone was attached to their lower back. The number of 30CST repetitions and the stopwatch-based TUG duration were recorded. Instrumented features were computed from the smartphone embedded inertial sensors. Four logistic regression models were fitted and the Areas Under the Receiver Operating Curve (AUC) were calculated and compared using the DeLong test. Standard clinical and instrumented measures of 30CST both showed equal moderate discriminative ability of 0.68 (95%CI 0.60⁻0.76), p = 0.97. Similarly, for TUG: AUC was 0.68 (95%CI 0.60⁻0.77) and 0.65 (95%CI 0.56⁻0.73), respectively, p = 0.26. In conclusion, both clinical and instrumented measures, recorded through a smartphone, can discriminate early functional decline in healthy adults aged 61⁻70 years.

Purpose, Frequency, and Mode of Transport by Which Older Adults Leave Their Home-A Cross-Sectional Analysis.

Time spent out-of-home can increase physical activity (PA) levels. However, the association between the purpose for leaving home and the mode of transport on time out-of-home and PA are not straightforward. In a large sample of community-dwelling older adults (≥65 years), daily walking duration was measured prospectively over 1 week using body-fixed sensors and time-out-of-home questionnaires. Data from 1,277 participants yielded 6,500 full days for analysis. The following statistically significant associations were seen: public transport use increased the time spent out-of-home by 88 min and daily walking duration by 16 min. Social contacts or the use of a car increased the time out-of-home, but decreased PA. Shopping or "going by foot" decreased the time spent out-of-home by 19 and 62 min, respectively, while both increased the daily walking duration by 5 min. The association between time out-of-home and PA (daily walking duration) is strongly dependent on the activity and mode of transport.

German version of the Community Balance and Mobility Scale : Translation and evaluation of measurement properties.

BACKGROUND: Tools to detect subtle balance deficits in high-functioning community-dwelling older adults are lacking. The Community Balance and Mobility Scale (CBM) is a valuable tool to measure balance deficits in this group; however, it is not yet available in the German language. OBJECTIVE: The aim was 1) to translate and cross-culturally adapt the CBM into the German language and 2) to investigate the measurement properties of the German CBM (G-CBM). MATERIAL AND METHODS: The original CBM was translated into the German language according to established guidelines. A total of 51 older adults (mean age 69.9 ± 7.1 years) were recruited to measure construct validity by comparing the G­CBM against standardized balance and/or mobility assessments including the Fullerton Advanced Balance Scale (FAB), Berg Balance Scale (BBS), 3 m Tandem Walk (3MTW), 8 Level Balance Scale (8LBS), 30 s Chair Stand Test (30CST), Timed Up and Go (TUG) test, gait speed, and the Falls Efficacy Scale International (FES-I). Intrarater and interrater reliability and internal consistency reliability were estimated using intraclass correlations (ICC) and Cronbach's alpha, respectively. Ceiling effects were calculated as the percentage of the sample scoring the maximum score. RESULTS: The G­CBM correlated excellently with FAB and BBS (ρ = 0.78-0.85; P < 0.001), good with 3MTW, TUG, and FES-I (ρ = -0.55 to -0.61; P < 0.001), and moderately with 8LBS, 30CST, and habitual gait speed (ρ = 0.32-0.46; P < 0.001). Intrarater (ICC3,k = 0.998; P < 0.001) and interrater (ICC2,k = 0.996; P < 0.001) reliability, and internal consistency reliability (α = 0.998) were also high. The G­CBM did not show ceiling effects. CONCLUSION: The G­CBM is a valid and reliable tool for measuring subtle balance deficits in older high-functioning adults. The absence of ceiling effects emphasizes the use of this scale in this cohort. The G­CBM can now be utilized in clinical practice.

Concurrent validity and reliability of the Community Balance and Mobility scale in young-older adults.

BACKGROUND: With the growing number of young-older adults (baby-boomers), there is an increasing demand for assessment tools specific for this population, which are able to detect subtle balance and mobility deficits. Various balance and mobility tests already exist, but suffer from ceiling effects in higher functioning older adults. A reliable and valid challenging balance and mobility test is critical to determine a young-older adult's balance and mobility performance and to timely initiate preventive interventions. The aim was to evaluate the concurrent validity, inter- and intrarater reliability, internal consistency, and ceiling effects of a challenging balance and mobility scale, the Community Balance and Mobility Scale (CBM), in young-older adults aged 60 to 70 years. METHODS: Fifty-one participants aged 66.4 ± 2.7 years (range, 60-70 years) were assessed with the CBM. The Fullerton Advanced Balance scale (FAB), 3-Meter Tandem Walk (3MTW), 8-level balance scale, Timed-Up-and-Go (TUG), and 7-m habitual gait speed were used to estimate concurrent validity, examined by Spearman correlation coefficient (ρ). Inter- and intrarater reliability were calculated as Intra-class-correlations (ICC), and internal consistency by Cronbach alpha and item-total correlations (ρ). Ceiling effects were determined by obtaining the percentage of participants reaching the highest possible score. RESULTS: The CBM significantly correlated with the FAB (ρ = 0.75; p < .001), 3MTW errors (ρ = - 0.61; p < .001), 3MTW time (ρ = - 0.35; p = .05), the 8-level balance scale (ρ = 0.35; p < .05), the TUG (ρ = - 0.42; p < .01), and 7-m habitual gait speed (ρ = 0.46, p < .001). Inter- (ICC2,k = 0.97), intrarater reliability (ICC3,k = 1.00) were excellent, and internal consistency (α = 0.88; ρ = 0.28-0.81) was good to satisfactory. The CBM did not show ceiling effects in contrast to other scales. CONCLUSIONS: Concurrent validity of the CBM was good when compared to the FAB and moderate to good when compared to other measures of balance and mobility. Based on this study, the CBM can be recommended to measure balance and mobility performance in the specific population of young-older adults. TRIAL REGISTRATION: Trial number: ISRCTN37750605 . (Registered on 21/04/2016).

Complexity of Daily Physical Activity Is More Sensitive Than Conventional Metrics to Assess Functional Change in Younger Older Adults.

The emerging mHealth applications, incorporating wearable sensors, enables continuous monitoring of physical activity (PA). This study aimed at analyzing the relevance of a multivariate complexity metric in assessment of functional change in younger older adults. Thirty individuals (60⁻70 years old) participated in a 4-week home-based exercise intervention. The Community Balance and Mobility Scale (CBMS) was used for clinical assessment of the participants’ functional balance and mobility performance pre- and post- intervention. Accelerometers worn on the low back were used to register PA of one week before and in the third week of the intervention. Changes in conventional univariate PA metrics (percentage of walking and sedentary time, step counts, mean cadence) and complexity were compared to the change as measured by the CBMS. Statistical analyses (21 participants) showed significant rank correlation between the change as measured by complexity and CBMS (ρ = 0.47, p = 0.03). Smoothing the activity output improved the correlation (ρ = 0.58, p = 0.01). In contrast, change in univariate PA metrics did not show correlations. These findings demonstrate the high potential of the complexity metric being useful and more sensitive than conventional PA metrics for assessing functional changes in younger older adults.

Reaction Time and Postural Sway Modify the Effect of Executive Function on Risk of Falls in Older People with Mild to Moderate Cognitive Impairment.

OBJECTIVES: To explore the relationship between cognitive performance and falls in older people with mild to moderate cognitive impairment (CI) by investigating the mediational effects of medical, medication, neuropsychological, and physiological factors. DESIGN: Secondary analysis, prospective cohort study. SETTING: Community and low-level care. PARTICIPANTS: 177 older people (aged 82 ± 7 years) with mild to moderate CI (MMSE 11-23; ACE-R < 83). MEASUREMENTS: Global cognition and six neuropsychological domains (memory, language, visuospatial, processing speed, executive function [EF], and affect) were assessed. Participants also underwent sensorimotor and balance assessments. Falls were recorded prospectively for 12 months. RESULTS: The EF domain was most strongly associated with multiple falls (relative risk [RR]: 1.50, 95% CI: 1.18-1.91). Global cognition was not associated with falls (RR: 1.09, 95% CI: 0.92-1.30). Additional analyses showed that participants with poorer EF (median cutpoint) were more likely to be taking centrally acting medications and were less physically active. They also had significantly worse vision, reaction time, knee extension strength, balance (postural sway, controlled leaning balance), and higher physiological fall risk scores. Participants with poorer EF were 1.5 times (RR: 1.50, 95% CI: 1.03-2.18) more likely to have multiple falls. Mediational analyses demonstrated that reaction time and postural sway reduced the relative risk of EF on multiple falls by 31% (RR: 1.19, 95% CI: 0.81-1.74). CONCLUSIONS: Within this sample of older people with mild to moderate CI, poorer EF increased the risk of multiple falls. This relationship was mediated by reaction time and postural sway,suggesting cognitively impaired older people with poorer EF may benefit from fall prevention programs targeting these mediating factors.

A multidisciplinary intervention to prevent subsequent falls and health service use following fall-related paramedic care: a randomised controlled trial.

Background: approximately 25% of older people who fall and receive paramedic care are not subsequently transported to an emergency department (ED). These people are at high risk of future falls, unplanned healthcare use and poor health outcomes. Objective: to evaluate the impact of a fall-risk assessment and tailored fall prevention interventions among older community-dwellers not transported to ED following a fall on subsequent falls and health service use. Design, setting, participants: Randomised controlled trial involving 221 non-transported older fallers from Sydney, Australia. Intervention: the intervention targeted identified risk factors and used existing services to implement physiotherapy, occupational therapy, geriatric assessment, optometry and medication management interventions as appropriate. The control group received individualised written fall prevention advice. Measurements: primary outcome measures were rates of falls and injurious falls. Secondary outcome measures were ambulance re-attendance, ED presentation, hospitalisation and quality of life over 12 months. Analysis was by intention-to-treat and per-protocol according to self-reported adherence using negative binominal regression and multivariate analysis. Results: ITT analysis showed no significant difference between groups in subsequent falls, injurious falls and health service use. The per-protocol analyses revealed that the intervention participants who adhered to the recommended interventions had significantly lower rates of falls compared to non-adherers (IRR: 0.53 (95% CI : 0.32-0.87)). Conclusion: a multidisciplinary intervention did not prevent falls in older people who received paramedic care but were not transported to ED. However the intervention was effective in those who adhered to the recommendations. Trial registration: the trial is registered at the Australian New Zealand Clinical Trials Registry: ACTRN 12611000503921, 13/05/2011.

Physical impairments in cognitively impaired older people: implications for risk of falls.

BACKGROUND: Cognitively impaired older people fall twice as often as their cognitively intact counterparts. There is, however, limited information on factors that increase the risk of falls in this population. This study aimed to determine whether a group of cognitively impaired older people (CIG) perform worse than a matched group of cognitively intact older people (NCIG) on a profile of physical performance and mobility tests. METHODS: One hundred and thirty-eight cognitively impaired and 276 age and gender matched cognitively intact community-dwelling older adults (>60 years) took part in the study. Participants completed a detailed physical performance battery from which composite fall risk scores were derived. Falls were measured prospectively for 12 months with monthly falls diaries, telephone calls, and by regularly contacting participants' "person responsible." RESULTS: The CIG performed worse than the NCIG in tests of reaction time, muscle strength (grip and quadriceps), balance (sway on floor, sway on foam, controlled leaning balance and near tandem standing ability), and mobility (sit to stand, timed up and go (TUG) and steps required to turn 180 degrees). The CIG had significantly higher composite fall risk scores than the NCIG and fell significantly more during follow-up (Multiple falls (2+): CIG 43%; NCIG 21%). CONCLUSIONS: Fall risk in the CIG was significantly increased due to multiple physical impairments. Physical profiles provide a means of quantifying the extent of impairment in older people with cognitive impairment and potential direction for targeting interventions for reducing fall risk.

Intervention to prevent further falls in older people who call an ambulance as a result of a fall: a protocol for the iPREFER randomised controlled trial.

BACKGROUND: An increasing number of falls result in an emergency call and the subsequent dispatch of paramedics. In the absence of physical injury, abnormal physiological parameters or change in usual functional status, it could be argued that routine conveyance by ambulance to the Emergency Department (ED) is not the most effective or efficient use of resources. Further, it is likely that non-conveyed older fallers have the potential to benefit from timely access to fall risk assessment and intervention. The aim of this randomised controlled trial is to evaluate the effect of a timely and tailored falls assessment and management intervention on the number of subsequent falls and fall-related injuries for non-conveyed older fallers. METHODS: Community dwelling people aged 65 years or older who are not conveyed to the ED following a fall will be eligible to be visited at home by a research physiotherapist. Consenting participants will receive individualised intervention strategies based on risk factors identified at baseline. All pre-test measures will be assessed prior to randomisation. Post-test measures will be undertaken by a researcher blinded to group allocation 6 months post-baseline. Participants in the intervention group will receive individualised pro-active fall prevention strategies from the clinical researcher to ensure that risk factors are addressed adequately and interventions carried out. The primary outcome measure will be the number of falls recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the subsequent use of medical and emergency services and uptake of recommendations. Data will be analysed using the intention-to-treat principle. DISCUSSION: As there is currently little evidence regarding the effectiveness or feasibility of alternate models of care following ambulance non-conveyance of older fallers, there is a need to explore assessment and intervention programs to help reduce subsequent falls, related injuries and subsequent use of health care services. By linking existing services rather than setting up new services, this pragmatic trial aims to utilise the health care system in an efficient and timely manner. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN 12611000503921.

Physiological fall risk factors in cognitively impaired older people: a one-year prospective study.

BACKGROUND/AIMS: Cognitively impaired older people are at twice the risk of falls compared to cognitively intact, with approximately 60% falling once or more per year. This study aimed to investigate sensorimotor and balance risk factors for falls in cognitively impaired older people. METHODS: 177 community-dwelling older people with mild to moderate cognitive impairment (Mini-Mental State Examination < 24, Addenbrooke's Cognitive Examination-Revised < 83) were assessed using the Physiological Profile Assessment (PPA). Falls were recorded prospectively for 12 months using monthly calendars with the assistance of carers. RESULTS: Seventy-one participants (43%) fell ≥2 times in the follow-up period. Impaired simple reaction time, postural sway, leaning balance and increased PPA fall risk score were significantly associated with multiple falls. The area under the receiver-operating characteristic curve for the PPA model including tests of vision, proprioception, knee extension strength, reaction time, postural sway and leaning balance was 0.75 (95% confidence interval: 0.68-0.83). CONCLUSION: These findings indicate poor performance on physiological fall risk factors, particularly balance, increases the risk of falls in older cognitively impaired people.

Gait impairment and falls in cognitively impaired older adults: an explanatory model of sensorimotor and neuropsychological mediators.

OBJECTIVES: to explore the associations between spatiotemporal gait parameters and falls in cognitively impaired older people and to investigate whether sensorimotor and neuropsychological factors mediate the association between gait performance and falls. DESIGN: prospective cohort study with a 1 year follow-up. SETTING: community-dwelling sample. PARTICIPANTS: sixty-four participants (62-96 years of age) with cognitive impairment. MEASUREMENTS: gait analysis and sensorimotor and neuropsychological functions were assessed in all participants. Falls were identified prospectively for 1 year. RESULTS: multiple fallers (≥2 falls) had significantly slower gait velocity, shorter stride length, greater double support time and increased step length variability in univariate analyses. Multivariate logistic regression indicated that the relationship between gait and falls was mediated primarily by sensorimotor function and to a lesser extent by neuropsychological performance. CONCLUSION: the findings indicate that slow and variable gait patterns increase the risk of falls in cognitively impaired older adults. Further, the association between gait and falls seems to be mediated in large by reduced sensorimotor functioning. Further research is needed to investigate whether interventions aimed at improving gait and/or sensorimotor fall risk factors, such as strength and balance, can prevent falls in cognitively impaired older adults.

Impact of adherence to a lifestyle-integrated programme on physical function and behavioural complexity in young older adults at risk of functional decline: a multicentre RCT secondary analysis.

CONTEXT: Long-term adherence to physical activity (PA) interventions is challenging. The Lifestyle-integrated Functional Exercise programmes were adapted Lifestyle-integrated Functional Exercise (aLiFE) to include more challenging activities and a behavioural change framework, and then enhanced Lifestyle-integrated Functional Exercise (eLiFE) to be delivered using smartphones and smartwatches. OBJECTIVES: To (1) compare adherence measures, (2) identify determinants of adherence and (3) assess the impact on outcome measures of a lifestyle-integrated programme. DESIGN, SETTING AND PARTICIPANTS: A multicentre, feasibility randomised controlled trial including participants aged 61-70 years conducted in three European cities. INTERVENTIONS: Six-month trainer-supported aLiFE or eLiFE compared with a control group, which received written PA advice. OUTCOME MEASURES: Self-reporting adherence per month using a single question and after 6-month intervention using the Exercise Adherence Rating Scale (EARS, score range 6-24). Treatment outcomes included function and disability scores (measured using the Late-Life Function and Disability Index) and sensor-derived physical behaviour complexity measure. Determinants of adherence (EARS score) were identified using linear multivariate analysis. Linear regression estimated the association of adherence on treatment outcome. RESULTS: We included 120 participants randomised to the intervention groups (aLiFE/eLiFE) (66.3±2.3 years, 53% women). The 106 participants reassessed after 6 months had a mean EARS score of 16.0±5.1. Better adherence was associated with lower number of medications taken, lower depression and lower risk of functional decline. We estimated adherence to significantly increase basic lower extremity function by 1.3 points (p<0.0001), advanced lower extremity function by 1.0 point (p<0.0001) and behavioural complexity by 0.008 per 1.0 point higher EARS score (F(3,91)=3.55, p=0.017) regardless of group allocation. CONCLUSION: PA adherence was associated with better lower extremity function and physical behavioural complexity. Barriers to adherence should be addressed preintervention to enhance intervention efficacy. Further research is needed to unravel the impact of behaviour change techniques embedded into technology-delivered activity interventions on adherence. TRIAL REGISTRATION NUMBER: NCT03065088.

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol.

BACKGROUND: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. METHODS/DESIGN: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. DISCUSSION: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. TRIAL REGISTRATION: ISRCTN12051706.

Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes.

Physical mobility is essential to health, and patients often rate it as a high-priority clinical outcome. Digital mobility outcomes (DMOs), such as real-world gait speed or step count, show promise as clinical measures in many medical conditions. However, current research is nascent and fragmented by discipline. This scoping review maps existing evidence on the clinical utility of DMOs, identifying commonalities across traditional disciplinary divides. In November 2019, 11 databases were searched for records investigating the validity and responsiveness of 34 DMOs in four diverse medical conditions (Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture). Searches yielded 19,672 unique records. After screening, 855 records representing 775 studies were included and charted in systematic maps. Studies frequently investigated gait speed (70.4% of studies), step length (30.7%), cadence (21.4%), and daily step count (20.7%). They studied differences between healthy and pathological gait (36.4%), associations between DMOs and clinical measures (48.8%) or outcomes (4.3%), and responsiveness to interventions (26.8%). Gait speed, step length, cadence, step time and step count exhibited consistent evidence of validity and responsiveness in multiple conditions, although the evidence was inconsistent or lacking for other DMOs. If DMOs are to be adopted as mainstream tools, further work is needed to establish their predictive validity, responsiveness, and ecological validity. Cross-disciplinary efforts to align methodology and validate DMOs may facilitate their adoption into clinical practice.

The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study.

OBJECTIVE: this study aimed to perform a comprehensive validation of the 16-item and 7-item Falls Efficacy Scale International (FES-I) by investigating the overall structure and measurement properties, convergent and predictive validity and responsiveness to change. METHOD: five hundred community-dwelling older people (70-90 years) were assessed on the FES-I in conjunction with demographic, physiological and neuropsychological measures at baseline and at 12 months. Falls were monitored monthly and fear of falling every 3 months. RESULTS: the overall structure and measurement properties of both FES-I scales, as evaluated with item response theory, were good. Discriminative ability on physiological and neuropsychological measures indicated excellent validity, both at baseline (n = 500, convergent validity) and at 1-year follow-up (n = 463, predictive validity). The longitudinal follow-up suggested that FES-I scores increased over time regardless of any fall event, with a trend for a stronger increase in FES-I scores when a person suffered multiple falls in a 3-month period. Additionally, using receiver-operating characteristic (ROC) curves, cut-points were defined to differentiate between lower and higher levels of concern. CONCLUSIONS: the current study builds on the previously established psychometric properties of the FES-I. Both scales have acceptable structures, good validity and reliability and can be recommended for research and clinical purposes. Future studies should explore the FES-I's responsiveness to change during intervention studies and confirm suggested cut-points in other settings, larger samples and across different cultures.