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.

Defining a competency framework for health and social professionals to promote healthy aging throughout the lifespan: an international Delphi study.

The promotion of healthy aging has become a priority in most parts of the world and should be promoted at all ages. However, the baseline training of health and social professionals is currently not adequately tailored to these challenges. This paper reports the results of a Delphi study conducted to reach expert agreement about health and social professionals' competencies to promote healthy aging throughout the lifespan within the SIENHA project. Materials and methods: This study was developed following the CREDES standards. The initial version of the competence framework was based on the results of a scoping review and following the CanMEDS model. The expert panel consisted of a purposive sample of twenty-two experts in healthy aging with diverse academic and clinical backgrounds, fields and years of expertise from seven European countries. Agreement was reached after three rounds. The final framework consisted of a set of 18 key competencies and 80 enabling competencies distributed across six domains. The SIENHA competence framework for healthy aging may help students and educators enrich their learning and the academic content of their subjects and/or programs and incentivize innovation.

Professional competences to promote healthy ageing across the lifespan: a scoping review.

As societies age, the development of resources and strategies that foster healthy ageing from the beginning of life become increasingly important. Social and healthcare professionals are key agents in this process; therefore, their training needs to be in agreement with societal needs. We performed a scoping review on professional competences for social and health workers to adequately promote healthy ageing throughout life, using the framework described by Arksey and O'Malley and the Joanna Briggs Institute Guidelines. A stakeholder consultation was held in each of the participating countries, in which 79 experts took part. Results show that current literature has been excessively focused on the older age and that more attention on how to work with younger population groups is needed. Likewise, not all disciplines have equally reflected on their role before this challenge and interprofessional approaches, despite showing promise, have not been sufficiently described. Based on our results, health and social professionals working to promote healthy ageing across the lifespan will need sound competences regarding person-centred communication, professional communication, technology applications, physiological and pathophysiological aspects of ageing, social and environmental aspects, cultural diversity, programs and policies, ethics, general and basic skills, context and self-management-related skills, health promotion and disease prevention skills, educational and research skills, leadership skills, technological skills and clinical reasoning. Further research should contribute to establishing which competences are more relevant to each discipline and at what level they should be taught, as well as how they can be best implemented to effectively transform health and social care systems.

Blended Care in Patients With Knee and Hip Osteoarthritis in Physical Therapy: Delphi Study on Needs and Preconditions.

BACKGROUND: Osteoarthritis is a major public health concern. Despite existing evidence-based treatment options, the health care situation remains unsatisfactory. Digital care options, especially when combined with in-person sessions, seem to be promising. OBJECTIVE: The aim of this study was to investigate the needs, preconditions, barriers, and facilitators of blended physical therapy for osteoarthritis. METHODS: This Delphi study consisted of interviews, an online questionnaire, and focus groups. Participants were physical therapists, patients with hip and/or knee osteoarthritis with or without experience in digital care, and stakeholders of the health care system. In the first phase, interviews were conducted with patients and physical therapists. The interview guide was based on the Consolidated Framework For Implementation Research. The interviews focused on experiences with digital and blended care. Furthermore, needs, facilitators, and barriers were discussed. In the second phase, an online questionnaire and focus groups served the process to confirm the needs and collect preconditions. The online questionnaire contained statements drawn by the results of the interviews. Patients and physical therapists were invited to complete the questionnaire and participate in one of the three focus groups including (1) patients; (2) physical therapists; and (3) a patient, a physical therapist, and stakeholders from the health care system. The focus groups were used to determine concordance with the results of the interviews and the online questionnaire. RESULTS: Nine physical therapists, seven patients, and six stakeholders confirmed that an increase of acceptance of the digital care part by physical therapists and patients is crucial. One of the most frequently mentioned facilitators was conducting regular in-person sessions. Physical therapists and patients concluded that blended physical therapy must be tailored to the patients' needs. Participants of the last focus group stated that the reimbursement of blended physical therapy needs to be clarified. CONCLUSIONS: Most importantly, it is necessary to strengthen the acceptance of patients and physical therapists toward digital care. Overall, for development and usage purposes, it is crucial to take the needs and preconditions into account. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023386; https://drks.de/search/en/trial/DRKS00023386.

Technologies in Home-Based Digital Rehabilitation: Scoping Review.

BACKGROUND: Due to growing pressure on the health care system, a shift in rehabilitation to home settings is essential. However, efficient support for home-based rehabilitation is lacking. The COVID-19 pandemic has further exacerbated these challenges and has affected individuals and health care professionals during rehabilitation. Digital rehabilitation (DR) could support home-based rehabilitation. To develop and implement DR solutions that meet clients' needs and ease the growing pressure on the health care system, it is necessary to provide an overview of existing, relevant, and future solutions shaping the constantly evolving market of technologies for home-based DR. OBJECTIVE: In this scoping review, we aimed to identify digital technologies for home-based DR, predict new or emerging DR trends, and report on the influences of the COVID-19 pandemic on DR. METHODS: The scoping review followed the framework of Arksey and O'Malley, with improvements made by Levac et al. A literature search was performed in PubMed, Embase, CINAHL, PsycINFO, and the Cochrane Library. The search spanned January 2015 to January 2022. A bibliometric analysis was performed to provide an overview of the included references, and a co-occurrence analysis identified the technologies for home-based DR. A full-text analysis of all included reviews filtered the trends for home-based DR. A gray literature search supplemented the results of the review analysis and revealed the influences of the COVID-19 pandemic on the development of DR. RESULTS: A total of 2437 records were included in the bibliometric analysis and 95 in the full-text analysis, and 40 records were included as a result of the gray literature search. Sensors, robotic devices, gamification, virtual and augmented reality, and digital and mobile apps are already used in home-based DR; however, artificial intelligence and machine learning, exoskeletons, and digital and mobile apps represent new and emerging trends. Advantages and disadvantages were displayed for all technologies. The COVID-19 pandemic has led to an increased use of digital technologies as remote approaches but has not led to the development of new technologies. CONCLUSIONS: Multiple tools are available and implemented for home-based DR; however, some technologies face limitations in the application of home-based rehabilitation. However, artificial intelligence and machine learning could be instrumental in redesigning rehabilitation and addressing future challenges of the health care system, and the rehabilitation sector in particular. The results show the need for feasible and effective approaches to implement DR that meet clients' needs and adhere to framework conditions, regardless of exceptional situations such as the COVID-19 pandemic.

Smartphone-assisted training with education for patients with hip and/or knee osteoarthritis (SmArt-E): study protocol for a multicentre pragmatic randomized controlled trial.

INTRODUCTION: Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care. METHODS: This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation. DISCUSSION: After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants' behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00028477. Registered on August 10, 2022.

Low test-retest reliability of a protocol for assessing somatosensory cortex excitability generated from sensory nerves of the lower back.

In people with chronic low back pain (CLBP), maladaptive structural and functional changes on a cortical level have been identified. On a functional level, somatosensory cortical excitability has been shown to be reduced in chronic pain conditions, resulting in cortical disinhibition. The occurrence of structural and/or functional maladaptive cortical changes in people with CLBP could play a role in maintaining the pain. There is currently no measurement protocol for cortical excitability that employs stimulation directly to the lower back. We developed a protocol for the measurement of single pulse somatosensory evoked potential (SEP) waveforms and paired-pulse behavior (PPB) generated from sensory nerves of the lower back and quantified its test-retest reliability in a sample of 30 healthy individuals to gain insights into the normal variability of cortical responses, which could then be compared to results from people with CLBP. We investigated cortical excitability by measuring SEPs and PPB. PPB was defined as the ratio of the amplitude of the second cortical response (A2s) divided by the first cortical response (A1). A2s was determined by subtracting the response to single-pulse stimuli from the paired pulse stimuli response to account for linear superposition effects. The test-retest reliability of the protocol was very poor with no evidence of systematic bias but a high amount of random variability between sessions. There was no significant difference in the right side PPB for session 1 (Mean ratio A2s/A1 = 0.66, SD = 0.54) and session 2 (Mean ratio A2s/A1 = 0.94, SD = 1.56); mean session difference [(95% CI) = -0.44 (-1.23 to 0.34); t (22) = -1.17, p = 0.26]. The ICC3.1 (absolute agreement) for the outlier-removed right side PPB were 0.19 (95% CI: -0.84 to 0.66) and 0.43 for left side PPB (95% CI: -0.37 to 0.76). This finding potentially has wider implications for PPB protocols. If these findings were replicated in other groups and other nerves, it would question the validity of this measure more generally. However, these findings are restricted to healthy people and sensory nerves of the lower back and may not be generalizable.

Association of clinical outcome assessments of mobility capacity and incident disability in community-dwelling older adults - a systematic review and meta-analysis.

The objective of the present review is to synthesize all available research on the association between mobility capacity and incident disability in non-disabled older adults. MEDLINE, EMBASE and CINAHL databases were searched without any limits or restrictions until February 2021. Published reports of longitudinal cohort studies that estimated a direct association between baseline mobility capacity, assessed with a standardized outcome assessment, and subsequent development of disability, including initially non-disabled older adults were included. The risk of bias was assessed using the Quality in Prognosis Studies (QUIPS) tool. Random-effect models were used to explore the objective. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. The main outcome measures were the pooled relative risks (RR) per one conventional unit per mobility assessment for incident disability. A total of 40 reports (85,515 participants at baseline) were included. For usual and fast gait speed, the RR per -0.1 m/s was 1.23 (95% CI: 1.18-1.28; 26,638 participants) and 1.28 (95% CI: 1.19-1.38; 8161 participants), respectively. Each point decrease in Short Physical Performance Battery score increased the risk of incident disability by 30% (RR = 1.30, 95% CI: 1.23-1.38; 9183 participants). The RR of incident disability by each second increase in Timed Up and Go test and Chair Rise Test performance was 1.15 (95% CI: 1.09-1.21; 30,426 participants) and 1.07 (95% CI: 1.04-1.10; 9450 participants), respectively. The review concludes that among community-dwelling non-disabled older adults, poor mobility capacity is a potent modifiable risk factor for incident disability. Mobility impairment should be mandated as a quality indicator of health for older people.

Feasibility of smartphone-supported, combined physical and cognitive activities in the Neighbourhood for stimulating social participation of the elderly.

BACKGROUND: Combining smartphone-assisted group activities in the neighbourhood and training in physical and cognitive skills may offer the potential to promote social participation and connectedness of older adults. This non-controlled proof-of-concept, retrospectively registered study aimed to determine the feasibility of such an intervention approach, including its evaluation. METHODS: In two consecutive six-month intervention cycles, 39 community-dwelling adults were provided with weekly smartphone, physical and cognitive training by two tutors. Using a specifically designed app, the participants were also encouraged to join and later self-organise physically and cognitively stimulating activities related to hot spots in their Bochum neighbourhood. Indicators of feasibility were documented. RESULTS: The recruitment and assessments took 3 hours per participant. Excluding smartphone support, the preparation and the implementation of the intervention amounted to nine person-hours per week. Six participants dropped out, and 13 did not complete one or more assessments. The participants attended 76 ± 15% of the weekly training sessions. The instructors deemed the programme feasible, but familiarisation with the smartphone and the app was very time-consuming. Twenty-seven of 29 participants reported high overall satisfaction, and 22 agreed that the programme helped them to establish social contacts. The smartphones attracted substantial interest and were used frequently, despite mixed satisfaction with the project-specific app. From baseline to follow-up, the six-minute walking distance, lower extremity strength and moderate to vigorous physical activity, as well as quality of life, were preserved at a high level, while balance performance was significantly improved. Of the 11 tests related to cognitive functioning, 4 tests (a memory test, the Stroop test and 2 tests of verbal fluency) indicated significant improvement. No moderate or serious adverse events occurred in relation to the assessments or the intervention. CONCLUSIONS: The multimodal approach seems safe and feasible and offers the potential to promote social connectedness, bonds in the residential neighbourhood and smartphone competency, as well as to preserve or improve physical and cognitive functions. Adaptations of the intervention and of the outcome assessments may contribute to better assessment and exploitation of the potential of this approach in a future study involving socially, physically and cognitively less active elderly persons.

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.

A generic outcome assessment of mobility capacity in neurorehabilitation: measurement properties of the de Morton Mobility Index.

BACKGROUND: Mobility capacity is a key outcome domain in neurorehabilitation. The de Morton Mobility Index (DEMMI), an established and generic outcome assessment of mobility capacity in older patients, is promising for use in neurorehabilitation. The aim of this study was to examine the measurement properties of the DEMMI in rehabilitation inpatients with neurological conditions. METHODS: Cross-sectional study including a mixed sample of adult inpatients in a neurorehabilitation hospital. Structural validity, unidimensionality and measurement invariance (Rasch analysis), construct validity, internal consistency reliability, and inter-rater reliability of the DEMMI (scale range: 0-100 points) were established. The minimal detectable change, the 95% limits of agreement, and possible floor and ceiling effects were calculated to indicate interpretability. RESULTS: We analyzed validity (n = 348) and reliability (n = 133) in two samples. In both samples, the majority of participants had a sub-acute stroke or Parkinson's disease. Rasch analysis indicated unidimensionality with an overall fit to the model (chi-square = 59.4, P = 0.074). There was no relevant measurement invariance by disease group. Hypotheses-based correlation analyses (DEMMI and other functional outcome assessments) showed sufficient construct validity. Internal consistency reliability (Cronbach's alpha = 0.94) and inter-rater reliability (intraclass correlation coefficient = 0.94; 95% confidence interval: 0.91-0.95) were sufficient. The minimal detectable change with 90% confidence was 15.0 points and the limits of agreement were 39%. No floor or ceiling effects were observed. CONCLUSIONS: Results indicate sufficient measurement properties of the DEMMI in rehabilitation inpatients with neurological conditions. The DEMMI can be used as a generic outcome assessment of mobility capacity in neurorehabilitation. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00004681 ). Registered May 6, 2013.

Responsiveness and interpretability of commonly used outcome assessments of mobility capacity in older hospital patients with cognitive spectrum disorders.

BACKGROUND: In older hospital patients with cognitive spectrum disorders (CSD), mobility should be monitored frequently with standardised and psychometrically sound measurement instruments. This study aimed to examine the responsiveness, minimal important change (MIC), floor effects and ceiling effects of commonly used outcome assessments of mobility capacity in older patients with dementia, delirium or other cognitive impairment. METHODS: In a cross-sectional study that included acute older hospital patients with CSD (study period: 02/2015-12/2015), the following mobility assessments were applied: de Morton Mobility Index (DEMMI), Hierarchical Assessment of Balance and Mobility (HABAM), Performance Oriented Mobility Assessment, Short Physical Performance Battery, 4-m gait speed test, 5-times chair rise test, 2-min walk test, Timed Up and Go test, Barthel Index mobility subscale, and Functional Ambulation Categories. These assessments were administered shorty after hospital admission (baseline) and repeated prior to discharge (follow-up). Global rating of mobility change scales and a clinical anchor of functional ambulation were used as external criteria to determine the area under the curve (AUC). Construct- and anchor-based approaches determined responsiveness. MIC values for each instrument were established from different anchor- and distribution-based approaches. RESULTS: Of the 63 participants (age range: 69-94 years) completing follow-up assessments with mild (Mini Mental State Examination: 19-24 points; 67%) and moderate (10-18 points; 33%) cognitive impairment, 25% were diagnosed with dementia alone, 13% with delirium alone, 11% with delirium superimposed on dementia and 51% with another cognitive impairment. The follow-up assessment was performed 10.8 ± 2.5 (range: 7-17) days on average after the baseline assessment. The DEMMI was the most responsive mobility assessment (all AUC > 0.7). For the other instruments, the data provided conflicting evidence of responsiveness, or evidence of no responsiveness. MIC values for each instrument varied depending on the method used for calculation. The DEMMI and HABAM were the only instruments without floor or ceiling effects. CONCLUSIONS: Most outcome assessments of mobility capacity seem insufficiently responsive to change in older hospital patients with CSD. The significant floor effects of most instruments further limit the monitoring of mobility alterations over time in this population. The DEMMI was the only instrument that was able to distinguish clinically important changes from measurement error. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00005591). Registered February 2, 2015.

An investigation of the measurement properties of the de Morton Mobility Index for measuring mobility capacity in hospital patients with Parkinson's disease.

OBJECTIVE: To examine the measurement properties of the de Morton Mobility Index (DEMMI), a performance-based clinical outcome assessment of mobility capacity, in hospital patients with Parkinson's disease. DESIGN: Cross-sectional study. PARTICIPANTS: Hospital patients with Parkinson's disease. MAIN OUTCOME MEASURE(S): Structural validity and unidimensionality (Rasch analysis), construct validity, internal consistency reliability, and inter-rater reliability of the de Morton Mobility Index (scale range: 0-100 points) were established. The minimal detectable change, the 95% limits of agreement and possible floor and ceiling effects were calculated to indicate interpretability. RESULTS: We analysed validity (n = 100; mean age: 70 years; 71% male) and reliability (n = 47; mean age: 71 years; 68% male) in two samples. The mean Hoehn and Yahr stage was 3.2 and the mean disease duration was 12 years in both samples. Rasch analysis indicated unidimensionality with an overall fit to the model (chi-square = 21.49, P = 0.122). Seventy-three percent of hypotheses on construct validity were confirmed. Internal consistency reliability (Cronbach's alpha = 0.91) and inter-rater reliability (intraclass correlation coefficient = 0.88; 95% confidence interval: 0.80 to 0.93) were sufficient. The minimal detectable change with 90% confidence was 17.5 points and the limits of agreement were 31%. No floor or ceiling effects were observed. The mean administration time was 6.6 minutes. CONCLUSION: This study provides evidence of unidimensionality, sufficient internal consistency reliability, inter-rater reliability, construct validity, and feasibility of the de Morton Mobility Index in hospital patients with Parkinson's disease. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00004681). Registered May 6, 2013.

Effects of a movement control and tactile acuity training in patients with nonspecific chronic low back pain and control impairment - a randomised controlled pilot study.

BACKGROUND: Nonspecific chronic low back pain (NSCLBP) is a heterogeneous condition that is associated with complex neuromuscular adaptations. Exercise is a widely administered treatment, but its effects are small to moderate. Tailoring patient-specific exercise treatments based on subgroup classification may improve patient outcomes. OBJECTIVE: In this randomised controlled pilot study, our objective was to compare the feasibility and possible effects of a specific sensorimotor treatment (SMT) with those of a general exercise (GE) programme on patients with NSCLBP and control impairment (CI). METHODS: Patients with NSCLBP and CI were randomised into an SMT or a GE programme spanning 6 sessions each. The feasibility criteria included the study design, assessments, interventions and magnitudes of effects, and costs. Adverse events were documented. Primary (pain, physical function, and quality of life) and secondary outcomes were assessed three times: twice at baseline (t1a and t1b) to estimate parameter stability and once after the intervention (t2). RESULTS: Two-hundred and twenty-seven patients were screened to include 34 participants with NSCLBP and CI. Both treatment programmes and the assessments seemed feasible because their durations and contents were perceived as adequate. The total cost per participant was €321. Two adverse events occurred (one not likely related to the SMT, one likely related to the GE intervention). The SMT showed a tendency for superior effects in terms of pain severity (SMT t1a 3.5, t2 1.1; GE t1a 3.0, t2 2.0), pain interference (SMT t1a 1.9, t2 0.4; GE t1a 1.5, t2 0.9), physical component of quality of life (SMT t1a 39, t2 46; GE t1a 45, t2 48), and movement control. CONCLUSIONS: The SMT approach proposed in this study is feasible and should be tested thoroughly in future studies, possibly as an addition to GE. To ensure the detection of differences in pain severity between SMT and GE in patients with NSCLBP with 80% power, future studies should include 110 patients. If the current results are confirmed, SMT should be considered in interventions for patients with NSCLBP and CI. TRIAL REGISTRATION: Registered in the German Register for Clinical Trials (Trial registration date: November 11, 2016; Trial registration number: DRKS00011063 ; URL of trial registry record); retrospectively registered.

An augmented prescribed exercise program (APEP) to improve mobility of older acute medical patients - a randomized, controlled pilot and feasibility trial.

BACKGROUND: There is inconclusive evidence for the effectiveness of additional exercise in older hospital patients. The aims of this study were (1) to assess the feasibility of an augmented prescribed exercise program (APEP) in older acute medical patients and (2) to measure the potential effects of APEP on mobility capacity in order to assess the feasibility of a large full-scale study. METHODS: We conducted a single-center, prospective, parallel-group, single-blinded, randomized (1:1) controlled pilot and feasibility trial. Participants were recruited from acute geriatric wards of a general hospital. Key inclusion criteria were: age ≥ 65 years and walking ability. Key exclusion criteria were severe cognitive impairment and medical restriction for physical exercise interventions. Both groups received usual care, including physiotherapy. Intervention group participants were scheduled for additional exercise sessions (20-30 min, 4-5x/week). Feasibility of the trial design was assessed along pre-defined criteria for process, resources and management. Feasibility of the APEP intervention was analyzed by means of adherence, compliance and safety. Outcomes were measured at baseline and prior to hospital discharge. The primary outcome was mobility capacity (de Morton Mobility Index; DEMMI). Secondary outcomes were walking ability, physical endurance, fear of falling, frailty and length of stay. RESULTS: Thirty-five participants were recruited (recruitment rate 20.3%). We lost 7 participants to follow-up (retention rate: 80%). Intervention group participants (n = 17) each participated in 5.3 ± 2.2 additional exercise sessions (mean duration: 23.2 ± 4.0 min; mean adherence rate 78% ± 26%). No severe adverse events occurred during study assessments or APEP sessions. There were no statistically significant differences in mean change scores in any outcome measure. A sample of 124 participants would be required to detect a difference of 4 DEMMI points (ES = 0.45) with a power of 80%. CONCLUSIONS: This small feasibility RCT indicates that an APEP intervention may be safe and feasible in older acute medical patients. APEP may possibly induce small to moderate effects on mobility, but the clinical relevance of these effects may be limited. These results inform the planning of a larger-scale phase III study. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00011262 ). Registered 27 October 2016.

Prevalence of frailty in older adults in outpatient physiotherapy in an urban region in the western part of Germany: a cross-sectional study.

OBJECTIVE: To investigate the prevalence of frailty in older people in outpatient physiotherapy services in an urban region in the western part of Germany. DESIGN: Cross-sectional study. SETTING: Outpatient physiotherapy clinics were recruited in the municipal area of the city of Bochum, Germany, and selected randomly. PARTICIPANTS: Older adults aged 65 years and older seeking outpatient physiotherapy. PRIMARY AND SECONDARY OUTCOME MEASURES: Prevalence of frailty was assessed based on the frailty phenotype model of physical frailty and the accumulation of deficit model, expressed as a Frailty Index. Prevalence was calculated for the whole sample and according to age-related, sex-related and diagnosis-related subgroups. RESULTS: A total of 258 participants (74±6 years, 62% female) from 11 out of 130 (8%) different physiotherapy clinics were included. Participants' main indication for physiotherapy was an orthopaedic or surgical condition (75%). According to the model of a physical frailty phenotype, 17.8% (95% CI 13.2 to 22.5) participants were frail and 43.4% (95% CI 37.4 to 49.5) were prefrail. The Frailty Index identified 31.0% (95% CI 25.4 to 36.7) of individuals as frail. In both models, prevalence increased with age and was higher in women than in men. Slow gait speed (34%), reduced muscle strength (34%) and exhaustion (28%) were the most prevalent indicators of physical frailty. CONCLUSIONS: Frailty is comparatively common in older patients attending physiotherapy care in Germany, with one out of three individuals being frail and every second individual being physically frail or prefrail. TRIAL REGISTRATION NUMBER: DRKS00009384; Results.

Reliability of mobility measures in older medical patients with cognitive impairment.

BACKGROUND: Mobility is a key indicator of physical functioning in older people, but there is limited evidence of the reliability of mobility measures in older people with cognitive impairment. This study aimed to examine the test-retest reliability and measurement error of common measurement instruments of mobility and physical functioning in older patients with dementia, delirium or other cognitive impairment. METHODS: A cross-sectional study was performed in a geriatric hospital. Older acute medical patients with cognitive impairment, indicated by a Mini-Mental State Examination (MMSE) score of ≤24 points, were assessed twice within 1 day by a trained physiotherapist. The following instruments were applied: de Morton Mobility Index, Hierarchical Assessment of Balance and Mobility, Performance-Oriented Mobility Assessment, Short Physical Performance Battery, 4-m gait speed, 5-times chair rise test, 2-min walk test, timed up and go test, Barthel Index mobility subscale and Functional Ambulation Categories. As appropriate, the intraclass correlation coefficient (ICC), Cohen's kappa, standard error of measurement, limits of agreement and minimal detectable change (MDC) values were estimated. RESULTS: Sixty-five older acute medical patients with cognitive impairment participated in the study (mean age: 82 ± 7 years; mean MMSE: 20 ± 4, range: 10 to 24 points). Some participants were physically or cognitively unable to perform the gait speed (46%), 2-min walk (46%), timed up and go (51%) and chair rise (75%) tests. ICC and kappa values were above 0.9 in all instruments except for the gait speed (ICC = 0.86) and chair rise (ICC = 0.72) measures. Measurement error is reported for each instrument. The absolute limits of agreement ranged from 11% (de Morton Mobility Index and Hierarchical Assessment of Balance and Mobility) to 35% (chair rise test). CONCLUSIONS: The test-retest reliability is sufficient (> 0.7) for group-comparisons in all examined instruments. Most mobility measurements have limited use for individual monitoring of mobility over time in older hospital patients with cognitive impairment because of the large measurement error (> 20% of scale width), even though relative reliability estimations seem sufficient (> 0.9) for this purpose. TRIAL REGISTRATION: German Clinical Trials Register ( DRKS00005591 ). Registered 2 February 2015.

Reliability and validity of the de Morton Mobility Index in individuals with sub-acute stroke.

PURPOSE: To establish the validity and reliability of the de Morton Mobility Index (DEMMI) in patients with sub-acute stroke. METHODS: This cross-sectional study was performed in a neurological rehabilitation hospital. We assessed unidimensionality, construct validity, internal consistency reliability, inter-rater reliability, minimal detectable change and possible floor and ceiling effects of the DEMMI in adult patients with sub-acute stroke. RESULTS: The study included a total sample of 121 patients with sub-acute stroke. We analysed validity (n = 109) and reliability (n = 51) in two sub-samples. Rasch analysis indicated unidimensionality with an overall fit to the model (chi-square = 12.37, p = 0.577). All hypotheses on construct validity were confirmed. Internal consistency reliability (Cronbach's alpha = 0.94) and inter-rater reliability (intraclass correlation coefficient = 0.95; 95% confidence interval: 0.92-0.97) were excellent. The minimal detectable change with 90% confidence was 13 points. No floor or ceiling effects were evident. CONCLUSIONS: These results indicate unidimensionality, sufficient internal consistency reliability, inter-rater reliability, and construct validity of the DEMMI in patients with a sub-acute stroke. Advantages of the DEMMI in clinical application are the short administration time, no need for special equipment and interval level data. The de Morton Mobility Index, therefore, may be a useful performance-based bedside test to measure mobility in individuals with a sub-acute stroke across the whole mobility spectrum. Implications for Rehabilitation The de Morton Mobility Index (DEMMI) is an unidimensional measurement instrument of mobility in individuals with sub-acute stroke. The DEMMI has excellent internal consistency and inter-rater reliability, and sufficient construct validity. The minimal detectable change of the DEMMI with 90% confidence in stroke rehabilitation is 13 points. The lack of any floor or ceiling effects on hospital admission indicates applicability across the whole mobility spectrum of patients with sub-acute stroke.

[Physical training as core component of multimodal treatment of older frail people-study protocol of a randomized controlled pilot study]. / Körperliches Training als Kernkomponente multimodaler Behandlung älterer Menschen mit Frailty ­ Studienprotokoll einer randomisierten kontrollierten Pilotstudie.

BACKGROUND AND OBJECTIVE: Clinical practice guidelines recommend a multimodal intervention based on standardized screening for the treatment of frailty, which includes physical exercise as the main component. This study protocol describes a planned randomized controlled pilot study to evaluate the feasibility of a main study and first assessment of the effects of a multimodal, resource-oriented intervention program on frailty in older people. METHODS AND ANALYSES: A total of 50 community-dwelling older men and women with frailty, ≥65 years of age, will be randomly allocated to the intervention or control group. The intervention group receives usual care and a multimodal intervention program. This program consists of a multidimensional screening, verbal counselling, written instructions on individual functional and health status, a home-based physical exercise program (high-intensity functional exercise program, HIFE), and support related to cognition, mood, risk of falling, medication, nutrition and self-care as required. The control group participants will receive usual care only. The feasibility will be assessed by indicators for processes, resources and management (practicability), as well as for acceptance, safety and possible effects of the intervention. The frailty index and secondary clinical endpoints will be assessed before and after the 3­month intervention, as well as after a 3-month follow-up to estimate the effects. Data will be analyzed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethics Committee of the German Physiotherapy Association (ref. number: 2017-02). Outcomes will be disseminated in a peer-reviewed journal and at specialist conferences. TRIAL REGISTRATION NUMBER: German Clinical Trial Register: DRKS00011831.

The translation, validity and reliability of the German version of the Fremantle Back Awareness Questionnaire.

BACKGROUND: The Fremantle Back Awareness Questionnaire (FreBAQ) claims to assess disrupted self-perception of the back. The aim of this study was to develop a German version of the FreBAQ (FreBAQ-G) and assess its test-retest reliability, its known-groups validity and its convergent validity with another purported measure of back perception. METHODS: The FreBaQ-G was translated following international guidelines for the transcultural adaptation of questionnaires. Thirty-five patients with non-specific CLBP and 48 healthy participants were recruited. Assessor one administered the FreBAQ-G to each patient with CLBP on two separate days to quantify intra-observer reliability. Assessor two administered the FreBaQ-G to each patient on day 1. The scores were compared to those obtained by assessor one on day 1 to assess inter-observer reliability. Known-groups validity was quantified by comparing the FreBAQ-G score between patients and healthy controls. To assess convergent validity, patient's FreBAQ-G scores were correlated to their two-point discrimination (TPD) scores. RESULTS: Intra- and Inter-observer reliability were both moderate with ICC3.1 = 0.88 (95%CI: 0.77 to 0.94) and 0.89 (95%CI: 0.79 to 0.94), respectively. Intra- and inter-observer limits of agreement (LoA) were 6.2 (95%CI: 5.0-8.1) and 6.0 (4.8-7.8), respectively. The adjusted mean difference between patients and controls was 5.4 (95%CI: 3.0 to 7.8, p<0.01). Patient's FreBAQ-G scores were not associated with TPD thresholds (Pearson's r = -0.05, p = 0.79). CONCLUSIONS: The FreBAQ-G demonstrated a degree of reliability and known-groups validity. Interpretation of patient level data should be performed with caution because the LoA were substantial. It did not demonstrate convergent validity against TPD. Floor effects of some items of the FreBAQ-G may have influenced the validity and reliability results. The clinimetric properties of the FreBAQ-G require further investigation as a simple measure of disrupted self-perception of the back before firm recommendations on its use can be made.