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69 result(s) for "Grüneberg, C."
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Usability and preliminary effectiveness of an app-based physical activity and education program for people with hip or knee osteoarthritis – a pilot randomized controlled trial
Background Hip and knee osteoarthritis (OA) are highly prevalent worldwide. The guidelines recommend physical activity and education as the core treatments for osteoarthritis. Digital health has the potential to engage people in physical activity and disease management. Therefore, we conducted a pilot trial to assess the usability and preliminary effectiveness of an app-based physical activity and education program ( Join2Move ) compared to usual care for people with hip and/or knee OA in Germany. Methods A randomized controlled pilot study was conducted. Individuals with diagnosed or self-reported knee and hip OA were included. Allocation to the intervention or control group was randomized. The intervention group received the Join2Move program. The Join2Move program was previously developed as a website and evaluated in the Netherlands. For the current study, the program was translated and adapted to the German context and adjusted from a website to an app. The control group received usual care. The primary outcomes were usability and preliminary effectiveness (pain and physical functioning). Measurements were taken at baseline and at twelve weeks. The data analysis was performed using SPSS (IBM SPSS Statistics 29.0). Results Sixty participants, with a mean age of 61.9 (SD ± 7.2) years, were allocated to the intervention ( n  = 32) or the control group ( n  = 28) and included in the analysis. The majority of participants had knee OA (68%), and 12% had hip and knee OA. The dropout rate was n  = 11 (18%). No adverse events were reported. Usability was rated as acceptable (mean System Usability Scale = 71.3/100) with a wide range (32.5 to 100). Statistically significant between-group differences were found only for pain (mean difference 8.52 (95% CI 1.01 to 16.04), p  = 0.027). Conclusions Join2Move demonstrated acceptable usability. The preliminary results of the pilot trial indicate the potential of a stand-alone app for the treatment of patients with hip or knee OA. However, the acceptable usability of Join2Move limits its recommendation for everyone. There appears to be room for improvement in app usability and in identifying patients for whom the app is suitable and the right time to use a stand-alone app. Trial registration German Clinical Trials Register DRKS00027164 .
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.
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.
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.
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.
Usability and Acceptability of an App-Based Approach to Treat Low Back Pain: Preplanned Secondary Analysis of a Randomized Controlled Trial
Low back pain (LBP) is a major cause of disability worldwide. To tackle issues such as long wait times and limited access to conventional care, telemedicine is emerging as a viable alternative. It offers benefits such as reduced travel and increased flexibility, with evidence showing comparable effectiveness to in-person care. However, usability remains a key challenge, impacting patient compliance. In a 3-arm randomized controlled trial, our preplanned secondary analysis aimed to assess the usability and patient perceptions toward an autonomous app-based intervention (\"NOLA\") for LBP to improve clinical practice of telemedicine interventions. Objectives included evaluating app usability, assessing perceptions toward telemedicine, and exploring app usage, adherence, and motivation. Patients with LBP were recruited from May to August 2022 and randomized into App, Physio+App, or Physio groups. App and Physio+App groups were included in this subanalysis. Intervention duration was 6 weeks. Data on baseline characteristics, System Usability Scale, Telemedicine Perception Questionnaire, app usage, adherence, and motivation were collected via web-based questionnaires. A total of 64 participants were randomized to use the app with available data for 38 participants. The mean age of participants who completed was 49.9 (SD 13.6) years, with 78% (29/38) experiencing LBP for more than 2 years. Usability scores (0-100) were good (Physio+App: median 78, IQR 58-92, app: median 86, IQR 65-91). Positive telemedicine perceptions were noted, with 84% (15/20) rating it an adequate addition to usual care. App usage varied, with 43% (16/35) using it 3 to 5 days per week, and 64% (21/33) reported motivation to use the app. The dropout rates (App: 14/32, 44%; Physio+App: 12/32, 38%; Physio: 11/29, 38%) were similar, but participants who dropped out had statistically significantly less pain (completers: mean 3.9, SD 2.0; dropouts: mean 3.0, SD 2.0; P=.02). Reasons for dropout were mostly not reported. The app \"NOLA\" demonstrated good usability, and participants expressed positive perceptions toward telemedicine in those who completed the intervention. Despite concerns about the lack of physical contact, the majority considered telemedicine a convenient form of health care delivery. App usage and motivation were favorable, emphasizing the potential of app-based interventions in managing LBP.
The influence of artificially increased hip and trunk stiffness on balance control in man
Lightweight corsets were used to produce mid-body stiffening, rendering the hip and trunk joints practically inflexible. To examine the effect of this artificially increased stiffness on balance control, we perturbed the upright stance of young subjects (20-34 years of age) while they wore one of two types of corset or no corset at all. One type, the \"half-corset\", only increased hip stiffness, and the other, the \"full-corset\", increased stiffness of the hips and trunk. The perturbations consisted of combined roll and pitch rotations of the support surface (7.5 deg, 60 deg/s) in one of six different directions. Outcome measures were biomechanical responses of the legs, trunk, arms and head, and electromyographic (EMG) responses from leg, trunk, and upper arm muscles. With the full-corset, a decrease in forward stabilising trunk pitch rotation compared to the no-corset condition occurred for backward pitch tilts of the support surface. In contrast, the half-corset condition yielded increased forward trunk motion. Trunk backward pitch motion after forwards support-surface perturbations was the same for all corset conditions. Ankle torques and lower leg angle changes in the pitch direction were decreased for both corset conditions for forward pitch tilts of the support-surface but unaltered for backward tilts. Changes in trunk roll motion with increased stiffness were profound. After onset of a roll support-surface perturbation, the trunk rolled in the opposite direction to the support-surface tilt for the no-corset and half-corset conditions, but in the same direction as the tilt for the full-corset condition. Initial head roll angular accelerations (at 100 ms) were larger for the full-corset condition but in the same direction (opposite platform tilt) for all conditions. Arm roll movements were initially in the same direction as trunk movements, and were followed by large compensatory arm movements only for the full-corset condition. Leg muscle (soleus, peroneus longus, but not tibialis anterior) balance-correcting responses were reduced for roll and pitch tilts under both corset conditions. Responses in paraspinals were also reduced. These results indicate that young healthy normals cannot rapidly modify movement strategies sufficiently to account for changes in link flexibility following increases in hip and trunk stiffness. The changes in leg and trunk muscle responses failed to achieve a normal roll or pitch trunk end position at 700 ms (except for forward tilt rotations), even though head accelerations and trunk joint proprioception seemed to provide information on changed trunk movement profiles over the first 300 ms following the perturbation. The major adaptation to stiffness involved increased use of arm movements to regain stability. The major differences in trunk motion for the no-corset, half-corset and full-corset conditions support the concept of a multi-link pendulum with different control dynamics in the pitch and roll planes as a model of human stance. Stiffening of the hip and trunk increases the likelihood of a loss of balance laterally and/or backwards. Thus, these results may have implications for the elderly and others, with and without disease states, who stiffen for a variety of reasons.
Physical training as core component of multimodal treatment of older frail people-study protocol of a randomized controlled pilot study
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. 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 3‑month 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. 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. German Clinical Trial Register: DRKS00011831.
Deutsche Version des De Morton Mobility Index
Zusammenfassung Hintergrund Der De Morton Mobility Index (DEMMI) ermöglicht in der englischen Originalversion eine reliable, valide, einfache und schnelle Messung der Mobilität stationärer geriatrischer Patienten, ohne dabei Decken- und Bodeneffekte aufzuweisen. Ziel der vorliegenden Studie war die interkulturelle Adaptation des DEMMI in die deutsche Sprache sowie die Prüfung von einigen psychometrischen Gütekriterien auf Grundlage dieses Prozesses. Material und Methoden Die Übersetzung des DEMMI wurde in einem mehrstufigen Verfahren anhand internationaler Richtlinien vorgenommen. Innerhalb der klinischen Erprobungsphase wurde der DEMMI in einer geriatrischen Klinik über 3 Wochen routinemäßig eingesetzt. Die Erfahrungen der Anwender wurden qualitativ ausgewertet und die Ergebnisse in Bezug auf Praktikabilität sowie Veränderungssensitivität des DEMMI analysiert. Ergebnisse Die erstellte deutsche DEMMI-Version wurde an 133 Patienten getestet. Die Durchführung des DEMMI nahm ca. 10 min in Anspruch. Dabei war er sicher sowie einfach durchführbar und wies keine Boden- und Deckeneffekte auf. Das gesamte Mobilitätsspektrum wurde abgebildet, wodurch mit dem DEMMI, im Gegensatz zum Timed Up and Go Test, Veränderungen der Mobilität hinreichend erfasst werden konnten. Schlussfolgerung Der DEMMI ist bereits im deutschsprachigen Raum anwendbar. Jedoch sind weitere Untersuchungen zu Validität und Reliabilität notwendig.