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.

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.

Adherence to a multifactorial fall prevention program following paramedic care: Predictors and impact on falls and health service use. Results from an RCT a priori subgroup analysis.

OBJECTIVE: To identify predictors and impact of adherence to a multifactorial fall-prevention program on falls and health service utilisation. METHODS: Randomised controlled trial with a priori subgroup analysis within intervention group according to adherence. Participants were community dwelling, (≥65 years), not transported to hospital following fall-related paramedic care. The Attitudes to Falls-Related Interventions Scale (AFRIS) was completed at baseline, adherence levels were measured (three-point scale) at six months, and falls and health service utilisation were recorded for 12 months. Multivariate logistic regression and area under the curve were calculated with 95% confidence interval (CI). RESULTS: Attitudes to Falls-Related Interventions Scale scores (n = 85) were independent of baseline characteristics. At six months, 39 (46%) participants reported full adherence. Independent predictors of adherence were positive AFRIS (OR 4.10, 95% CI 1.48-11.39) and receiving 3+ recommendations (OR 3.36, 95% CI 1.26-9.00). Adherers experienced fewer falls (IRR 0.53, 95% CI 0.45-0.80) and fall-related health service use (emergency department presentations IRR 0.37, 95% CI 0.17-0.82) compared to non-adherers. CONCLUSION: Older adults who adhere to recommendations benefit, regardless of fall-risk profile.

Systematic review of non-transportation rates and outcomes for older people who have fallen after ambulance service call-out.

AIM: To review the evidence regarding non-transported older people who have fallen in relation to non-transportation rates, outcomes and impact of alternate care pathways. METHOD: Electronic databases and reference lists of included studies (up to December 2011) were systematically searched. Studies were eligible if they included data on non-transportation rates, information on outcomes or alternate care pathways for older people who have fallen. RESULTS: Twelve studies were included. Non-transportation rates following a fall ranged from 11% to 56%. Up to 49% of non-transported people who have fallen had unplanned health-care contact within 28 days of the initial incident. Attendance by specially trained paramedics and individualised multifactorial interventions significantly reduced adverse events including subsequent falls, emergency ambulance calls, emergency department attendance and hospital admission. CONCLUSION: Limited but promising evidence shows that appropriate interventions can improve health outcomes of non-transported older people who have fallen. Further studies are needed to explore alternate care pathways and promote more efficient use of health services.

Older fallers attended to by an ambulance but not transported to hospital: a vulnerable population at high risk of future falls.

OBJECTIVE: This prospective cohort study describes older non-transported fallers seen by the Ambulance Service of New South Wales (ASNSW), quantifies the level of risk and identifies predictors of future falls and ambulance use. METHODS: Participants were 262 people aged 70 years or older with a fall-related ASNSW attendance who were not transported to an emergency department. They completed a questionnaire about health, medical and physical factors previously associated with falling. Falls were monitored for six months after ambulance attendance with monthly fall calendars. RESULTS: Participants had a high prevalence of chronic medical conditions, functional limitations and past falls. During follow-up, 145 participants (58%) experienced 488 falls. Significant predictors of falls during follow-up were three or more falls in the past year, being unable to walk more than 10 minutes without resting, and requiring assistance for personal-care activities of daily living (ADLs). Sixty-two participants (25%) required repeat, fall-related ambulance attendance during the study. Predictors of repeat ambulance use were: 3+ falls in past year, requiring assistance for personal-care ADLs and having disabling pain in past month. CONCLUSIONS: Older, non-transported fallers seen by the ASNSW are a vulnerable population with high rates of chronic health conditions. IMPLICATIONS: Onward referral for preventive interventions may reduce future falls and ambulance service calls.