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 .

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Adapted Lifestyle-Integrated Functional Exercise Program for Preventing Functional Decline in Young Seniors: Development and Initial Evaluation.

BACKGROUND: The Lifestyle-integrated Functional Exercise (LiFE) program is an intervention integrating balance and strength activities into daily life, effective at reducing falls in at-risk people ≥70 years. There is potential for LiFE to be adapted to young seniors in order to prevent age-related functional decline. OBJECTIVE: We aimed to (1) develop an intervention by adapting Lifestyle-integrated Functional Exercise (aLiFE) to be more challenging and suitable for preventing functional decline in young seniors in their 60s and (2) perform an initial feasibility evaluation of the program. Pre-post changes in balance, mobility, and physical activity (PA) were also explored. METHODS: Based on a conceptual framework, a multidisciplinary expert group developed an initial aLiFE version, including activities for improving strength, neuromotor performances, and PA. Proof-of-concept was evaluated in a 4-week pre-post intervention study measuring (1) feasibility including adherence, frequency of practice, adverse events, acceptability (i.e., perceived helpfulness, adaptability, level of difficulty of single activities), and safety, and (2) changes in balance/mobility (Community Balance and Mobility Scale) and PA (1 week activity monitoring). The program was refined based on the study results. RESULTS: To test the initial aLiFE version, 31 young seniors were enrolled and 30 completed the study (mean age 66.4 ± 2.7 years, 60% women). Of a maximum possible 16 activities, participants implemented on average 12.1 ± 1.8 activities during the intervention, corresponding to mean adherence of 76%. Implemented activities were practiced 3.6-6.1 days/week and 1.8-7.8 times/day, depending on the activity type. One noninjurious fall occurred during practice, although the participant continued the intervention. The majority found the activities helpful, adaptable to individual lifestyle, appropriately difficult, and safe. CMBS score increased with medium effect size (d = 0.72, p = 0.001). Increase in daily walking time (d = 0.36) and decrease in sedentary time (d = -0.10) were nonsignificant. Refinements included further increasing the task challenge of some strength activities and defining the most preferred activities in the trainer's manual to facilitate uptake of the program. CONCLUSION: aLiFE has the potential to engage young seniors in regular lifestyle-integrated activities. Effectiveness needs to be evaluated in a randomized controlled trial.

Inter-rater reliability, sensitivity to change and responsiveness of the orthopaedic Wolf-Motor-Function-Test as functional capacity measure before and after rehabilitation in patients with proximal humeral fractures.

BACKGROUND: The incidence of proximal humeral fractures (PHF) increased by more than 30% over the last decade, which is accompanied by an increased number of operations. However, the evidence on operative vs. non-operative treatment and post-operative treatments is limited and mostly based on expert opinion. It is mandatory to objectively assess functional capacity to compare different treatments. Clinical tools should be valid, reliable and sensitive to change assessing functional capacity after PHFs. This study aimed to analyse inter-rater reliability of the videotaped Wolf-Motor-Function-Test-Orthopaedic (WMFT-O) and the association between the clinical WMFT-O and the Disability of the Arm, Shoulder and Hand (DASH) and to determine the sensitivity to change of the WMFT-O and the DASH to measure functional capacity before and after rehabilitation in PHF patients. METHODS: Fifty-six patients (61.7 ± 14.7 years) after surgical treatment of PHF were assessed using the WMFT-O at two different time points. To determine inter-rater reliability, the videotaped WMFT-O was evaluated through three blinded raters. Inter-rater agreement was determined by Fleiss' Kappa statistics. Pearson correlation coefficients were calculated to assess the association between the clinical WMFT-O and the video rating as well as the DASH. Sensitivity to change and responsiveness were analysed for the WMFT-O and the DASH in a subsample of forty patients (53.8 ± 1.4 years) who were assessed before and after a three week robotic-assisted training intervention. RESULTS: Inter-rater agreement was indicated by Fleiss' Kappa values ranging from 0.33-0.66 for functional capacity and from 0.27-0.54 for quality of movement. The correlation between the clinical WMFT-O and the video rating was higher than 0.77. The correlation between the clinical WMFT-O and the DASH was weak. Sensitivity to change was high for the WMFT-O and the DASH and responsiveness was given. In comparison to the DASH, the sensitivity to change of the WMFT-O was higher. CONCLUSION: The overall results indicate that the WMFT-O is a reliable, sensitive and responsive instrument to measure more objectively functional change over time in rehabilitation after PHF. Furthermore, it has been shown that video assessment is eligible for studies to ensure a full blinding of raters. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03100201 . Registered on 28 March 2017. The trial was retrospectively registered.

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.

Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial.

BACKGROUND: The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness. METHODS: In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well. DISCUSSION: Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls. TRIAL REGISTRATION: ClinicalTrials.gov NCT03462654 . Registered on March 12, 2018.

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).

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.