Prevention at home in older persons with (pre-)frailty: analysis of participants' recruitment and characteristics of the randomized controlled PromeTheus trial.

BACKGROUND: The "PromeTheus" trial is evaluating a home-based, multifactorial, interdisciplinary prevention program for community-dwelling (pre-)frail older adults. These individuals often suffer from reduced participation, which can complicate the recruitment and enrollment in a clinical trial. AIMS: The aim of this study was to evaluate different recruitment strategies and differences in participant characteristics in relation to these strategies. METHODS: This cross-sectional study used baseline data from the randomized-controlled PromeTheus trial, in which community-dwelling (pre-)frail older persons (Clinical Frailty Scale [CFS] 4-6 pt., ≥ 70 years) were recruited via general practitioners ("GP recruitment") or flyers, newspaper articles, and personalized letters ("direct recruitment"). Differences in the sociodemographic, clinical, physical, functional, mobility-related, psychological and social characteristics were analyzed in relation to the recruitment strategy. RESULTS: A total of 385 participants (mean age = 81.2, SD 5.9 years; women: n = 283, 73.5%) were enrolled, of which 60 (16%) were recruited by GPs and 325 (84%) through direct recruitment. Participants recruited via GPs had significantly higher subjective frailty levels (CFS), were more often physically frail (Fried Frailty Phenotype), and showed lower physical capacity (Short Physical Performance Battery), participation (disability component of the short version of the Late-Life Function and Disability Instrument), and life-space mobility (Life-Space Assessment) compared to those recruited via the direct approach (p = 0.002-0.026). Costs per randomized participant were 94€ for the GP recruitment strategy and €213 for the direct recruitment strategy. CONCLUSION: Different strategies may be required to successfully recruit (pre-)frail home-living older adults into preventive programs. Direct recruitment strategies, in which potential participants are directly informed about the prevention program, seem to be more promising than GP recruitment but may result in enrolment of persons with less functional impairment and higher recruitment costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00024638. Registered on March 11, 2021.

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 .

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.

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.

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.

A multifactorial interdisciplinary intervention to prevent functional and mobility decline for more participation in (pre-)frail community-dwelling older adults (PromeTheus): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Age-related decline in physical capacity can lead to frailty, associated with an increased vulnerability to adverse health outcomes and greater healthcare utilization. In an aging population, effective strategies to prevent physical decline and frailty, and preserve independence are needed. Prevention programs for vulnerable community-dwelling older adults are, however, often not yet established and implemented in routine practice. Research on the feasibility, implementation, and (cost-)effectiveness of multifactorial, interdisciplinary intervention programs that take advantage of available services of healthcare providers is also limited. The main aim of this study is to evaluate the effectiveness of such an intervention program (PromeTheus) to prevent functional and mobility decline for more participation in community-dwelling (pre-)frail older adults. METHODS: The study is designed as a three-center, randomized controlled trial with a 12-month intervention period. Four hundred community-dwelling (pre-)frail (Clinical Frailty Scale score 4-6) older adults (≥70 years) will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will receive the PromeTheus program consisting of obligatory home-based physical exercises (Weight-bearing Exercise for Better Balance) accompanied by physiotherapists and facultative counseling services (person-environment-fit, coping with everyday life, nutrition, group-based activities) delivered via existing healthcare structures (e.g., social workers, nutritionists). The CG will receive usual care and a one-time counseling session on recommendations for physical activity and nutrition. Primary outcomes assessed at months 6 and 12 are the function component of the Late-Life Function and Disability Instrument and the University of Alabama at Birmingham Life-Space Assessment. Secondary outcomes are disability, physical capacity and activity, frailty, nutritional status, falls, fear of falling, health status, and psychosocial components. Process and economic evaluations are also conducted. Primary statistical analyses will be based on the intention-to-treat principle. DISCUSSION: Compared to usual care, the PromeTheus program is expected to result in higher function and mobility, greater independence and lower need for care, and more participation. As the PromeTheus program draws on existing German healthcare structures, its large-scale translation and delivery will be feasible, if evidence of (cost-)effectiveness and successful implementation can be demonstrated. TRIAL REGISTRATION: German Clinical Trials Register, . Registered on March 11, 2021.

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.

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.

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.

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.

Association between everyday walking activity, objective and perceived risk of falling in older adults.

BACKGROUND: older persons can be grouped according to their objective risk of falling (ORF) and perceived risk of falling (PRF) into 'vigorous' (low ORF/PRF), 'anxious' (low ORF/high PRF), 'stoic' (high ORF/low PRF) and 'aware' (high ORF/PRF). Sensor-assessed daily walking activity of these four groups has not been investigated, yet. OBJECTIVE: we examined everyday walking activity in those four groups and its association with ORF and PRF. DESIGN: cross-sectional. SETTING: community. SUBJECTS: N = 294 participants aged 70 years and older. METHODS: ORF was determined based on multiple independent risk factors; PRF was determined based on the Short Falls Efficacy Scale-International. Subjects were allocated to the four groups accordingly. Linear regression was used to quantify the associations of these groups with the mean number of accelerometer-assessed steps per day over 1 week as the dependent variable. 'Vigorous' was used as the reference group. RESULTS: average number of steps per day in the four groups were 6,339 ('vigorous'), 5,781 ('anxious'), 4,555 ('stoic') and 4,528 ('aware'). Compared with the 'vigorous', 'stoic' (-1,482; confidence interval (CI): -2,473; -491) and 'aware' (-1,481; CI: -2,504; -458) participants took significantly less steps, but not the 'anxious' (-580 steps; CI: -1,440; 280). CONCLUSION: we have integrated a digital mobility outcome into a fall risk categorisation based on ORF and PRF. Steps per day in this sample of community-dwelling older persons were in accordance with their ORF rather than their PRF. Whether this grouping approach can be used for the specification of participants' needs when taking part in programmes to prevent falls and simultaneously promote physical activity remains to be answered in intervention studies.

Group or individual lifestyle-integrated functional exercise (LiFE)? A qualitative analysis of acceptability.

BACKGROUND: The Lifestyle-integrated Functional Exercise (LiFE) program is an effective but resource-intensive fall prevention program delivered one-to-one in participants' homes. A recently developed group-based LiFE (gLiFE) could enhance large-scale implementability and decrease resource intensity. The aim of this qualitative focus group study is to compare participants' experiences regarding acceptability of gLiFE vs LiFE. METHODS: Programs were delivered in seven group sessions (gLiFE) or seven individual home visits (LiFE) within a multi-center, randomized non-inferiority trial. Four structured focus group discussions (90-100 min duration; one per format and study site) on content, structure, and subjective effects of gLiFE and LiFE were conducted. Qualitative content analysis using the method of inductive category formation by Mayring was applied for data analysis. Coding was managed using NVivo. RESULTS: In both formats, participants (N = 30, 22 women, ngLiFE = 15, nLiFE = 15, mean age 78.8 ± 6.6 years) were positive about content, structure, and support received by trainers. Participants reflected on advantages of both formats: the social aspects of learning the program in a peer group (gLiFE), and benefits of learning the program at home (LiFE). In gLiFE, some difficulties with the implementation of activities were reported. In both formats, the majority of participants reported positive outcomes and successful implementation of new movement habits. CONCLUSION: This is the first study to examine participants' views on and experiences with gLiFE and LiFE, revealing strengths and limitations of both formats that can be used for program refinement. Both formats were highly acceptable to participants, suggesting that gLiFE may have similar potential to be adopted by adults aged 70 years and older compared to LiFE. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03462654 . Registered on March 12, 2018.

Applying Social Cognition Models to Explain Walking Duration in Older Adults: The Role of Intrinsic Motivation.

This study examined the applicability of the health action process approach (HAPA) to walking duration in older adults and the added value of extending the HAPA by intrinsic motivation. Self-reports from older adults (N = 309; Mage = 78.7, 70-95 years) regarding activity-related intrinsic motivation and HAPA variables were collected at the baseline of a fall prevention intervention study. Walking duration at ≥3 metabolic equivalents of task was measured for 7 days via body-worn accelerometers. Two structural equation models with walking duration as a manifest outcome were specified. In both models, the model fit was acceptable, but intention and planning were not associated with walking duration. Intrinsic motivation was significantly related to most HAPA variables and walking duration. Variance explained for walking duration was R2 = .14 in the HAPA and R2 = .17 in the extended model. For explaining older adults' walking duration, intrinsic motivation, but not HAPA-based intention and planning, seemed to be important.

Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial.

OBJECTIVE: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). DESIGN: Multicentre, assessor-blinded, randomised controlled prospective trial. SETTING: Three different rehabilitation hospitals in Germany. SUBJECTS: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). INTERVENTION: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO®-Spring. MAIN MEASURES: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. RESULTS: The mean age of participants was 55 ± 10 years and was similar in both groups (p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was -15 (CI = 8-22), at follow-up six month -7 (CI = -2 to 16) at follow up 13 month -9 (CI = 1-16); in control group -14 (CI = 11-18), at follow-up six month -13 (CI = 7-19) at follow up 13 month -6 (CI = -3 to 14). No difference in the change was found between groups (p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. CONCLUSION: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

Mediating factors on the association between fear of falling and health-related quality of life in community-dwelling German older people: a cross-sectional study.

BACKGROUND: Previous research has shown that not only falls, but also fear of falling (FoF) influences health-related quality of life (HrQoL) negatively. The EQ-5D (consisting of an index and a visual analogue scale [EQ-VAS]) is a frequently used instrument to determine HrQoL in clinical studies and economic evaluations, but no previous study compared the association between FoF and the EQ-5D index with the association between FoF and the EQ-VAS. Moreover, factors that influence the association between FoF and HrQoL are rarely examined. Thus, this study aimed to examine the association between FoF and HrQoL and to examine factors that mediate the association. METHODS: FoF (Short Falls Efficacy Scale International) and HrQoL (EQ-5D descriptive system, EQ-5D index, and EQ-VAS) were assessed in a sample of community-dwelling older persons (≥70 years) participating in the baseline assessment of a randomized controlled trial (N = 309). Linear and logistic regression analyses were performed, adjusting for sociodemographic variables, frequency of falls, number of chronic conditions, functional mobility (Timed up-and-go test), and subjective functional capacity (LLFDI function and disability scales). Multiple regression models were used to test the mediating effects. RESULTS: Moderate or high FoF was prevalent in 66% of the sample. After adjusting for covariates, FoF was negatively associated with the EQ-5D index, but not with the descriptive system or the EQ-VAS. Subjective functional capacity partly mediated the association between FoF and the EQ-5D index and completely mediated the association between FoF and the EQ-VAS. CONCLUSION: FoF was negatively associated with the EQ-5D index. As subjective functional capacity mediated the association between FoF and HrQoL, future interventions should account for subjective functional capacity in their design.

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.

The association of basic and challenging motor capacity with mobility performance and falls in young seniors.

BACKGROUND: Understanding the association between motor capacity (MC) (what people can do in a standardized environment), mobility performance (MP) (what people actually do in real-life) and falls is important for early detection of and counteracting on functional decline, particularly in the rapidly growing population of young seniors. Therefore, this study aims to 1) explore the association between MC and MP, and between MC and falls, and 2) investigate whether challenging MC measures are better associated with MP and falls than basic MC measures. METHODS: Basic (habitual gait speed, Timed Up-and-Go) and challenging (fast gait speed, Community Balance & Mobility Scale) MC measures were performed in 169 young seniors (61-70 years). MP was assessed using one-week sensor-monitoring including time being sedentary, light active, and at least moderately active. Falls in the previous six months were reported. Associations and discriminative ability were calculated using correlation, regression and receiver operating curve analysis. RESULTS: Mean age was 66.4 (SD 2.4) years (50.6 % women). Small to moderate associations (r = 0.06-0.31; p < .001-.461) were found between MC, MP and falls. Challenging MC measures showed closer associations with MP and falls (r = 0.10-0.31; p < .001-.461) compared to basic (r = 0.06-0.22; p = .012-.181), remained significant in three out of four regression models explaining 2.5-8.6 % of the variance, and showed highest discriminative ability (area under the curve = 0.59-0.70) in all analyses. CONCLUSIONS: Challenging MC measures are closer associated with mobility performance and falls as compared to basic MC measures in young seniors. This indicates the importance of applying challenging motor capacity assessments in young seniors. On the same note, small to moderate associations imply a need for an assessment of both MC and MP in order to capture the best possible MC and the actual daily-life MP in young seniors.

Development of a conceptual framework for a group-based format of the Lifestyle-integrated Functional Exercise (gLiFE) programme and its initial feasibility testing.

BACKGROUND: The Lifestyle-integrated Functional Exercise (LiFE) programme is a fall prevention programme originally taught in a resource-intensive one-to-one format with limited feasibility for large-scale implementation. The aim of this paper is to present the conceptual framework and initial feasibility evaluation of a group-based LiFE (gLiFE) format developed for large-scale implementation. METHODS: The conceptual gLiFE framework (part I) is based on three pillars, LiFE Activities and Principles, Theory of Behaviour Change and Behaviour Change Techniques, and Instruction. The feasibility of gLiFE was tested (part II) within a multimodal approach including quantitative questionnaires measuring safety, acceptability (1 = best to 7 = insufficient), and adherence to the LiFE activities (range = 0-14) as well as a focus group interview. Exploratory self-reported measures on behaviour change including self-determined motivation (range = 1-5), intention, planning, action control, and habit strength (range = 1-6) were assessed pre and post intervention. Data analyses were performed using descriptive statistics and qualitative content analysis. RESULTS: The development process resulted in a manualised gLiFE concept containing standardised information on gLiFE's content and structure. Feasibility testing: Six older adults (median = 72.8 years, 5 female) completed the feasibility study and rated safety (median = 7.0, IQR = 0.3) and acceptability as high (median = 1, IQR = 1). Participants implemented 9.5 LiFE activities (IQR = 4.0) into their daily routines. No adverse events occurred during the study. In the focus group, the group format and LiFE activities were perceived as positive and important for maintaining strength and balance capacity. Self-determined motivation intention, planning, and habit strength were rated higher post intervention. CONCLUSION: The developed conceptual gLiFE framework represents the basis for a gLiFE format with potential for standardised large-scale implementation. Proof-of-concept could be demonstrated in a group of community-dwelling older adults at risk of falling. The public health potential of gLiFE in terms of (cost-)effectiveness is currently being evaluated in a large trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT03412123. Registered on January 26, 2018.

Creating and Validating a Shortened Version of the Community Balance and Mobility Scale for Application in People Who Are 61 to 70 Years of Age.

BACKGROUND: The Community Balance and Mobility Scale (CBM) has been shown to be reliable and valid for detecting subtle balance and mobility deficits in people who are 61 to 70 years of age. However, item redundancy and assessment time call for a shortened version. OBJECTIVE: The objective was to create and validate a shortened version of the CBM (s-CBM) without detectable loss of psychometric properties. DESIGN: This was a cross-sectional study. METHODS: Exploratory factor analysis with data from 189 young seniors (aged 61-70 years; mean [SD] age = 66.3 [2.5] years) was used to create the s-CBM. Sixty-one young seniors (aged 61-70 years; mean [SD] age = 66.5 [2.6] years) were recruited to assess construct validity (Pearson correlation coefficient) by comparing the CBM versions with Fullerton Advance Balance Scale, Timed Up-and-Go, habitual and fast gait speed, 8 Level Balance Scale, 3-m tandem walk, and 30-second chair stand test. Internal consistency (Cronbach α), ceiling effects, and discriminant validity (area under the curve [AUC]) between fallers and nonfallers, and self-reported high and low function (Late-Life Function and Disability Index) and balance confidence (Activities-Specific Balance Confidence Scale), respectively, were calculated. RESULTS: The s-CBM, consisting of 4 items, correlated excellently with the CBM (r = 0.97). Correlations between s-CBM and other assessments (r = 0.07-0.72), and CBM and other assessments (r = 0.06-0.80) were statistically comparable in 90% of the correlations. Cronbach α was .84 for the s-CBM, and .87 for the CBM. No CBM-version showed ceiling effects. Discriminative ability of the s-CBM was statistically comparable with the CBM (AUC = 0.66-0.75 vs AUC = 0.65-0.79). LIMITATIONS: Longitudinal studies with larger samples should confirm the results and assess the responsiveness for detecting changes over time. CONCLUSIONS: The psychometric properties of the s-CBM were similar to those of the CBM. The s-CBM can be recommended as a valid and quick balance and mobility assessment in young seniors.