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Background: Vertebral and pelvic fractures are associated with a significant burden of negative health and psychosocial outcomes. The number of vertebral and pelvic fractures is increasing in an aging society. Vertebral and pelvic fractures are increasingly significant injuries for individuals and society. However, few epidemiological studies have examined the clinical course of vertebral and pelvic fractures. This is the protocol for a study that observes patients who have been admitted to the hospital with an incident vertebral or pelvic fracture for a period of 12 months. Methods: The observational cohort study is conducted at three study sites in Germany. Patients affected by vertebral or pelvic fractures are recruited within the first few days of hospital admission. Data collection takes place at four-time points: baseline, before discharge, after 4 months, and after 12 months after admission to the hospital. Particular emphasis is laid on the assessment of the fall mechanisms, physical function, physical activity, life space, mobility, treatment approach, and quality of life. The hospital stay involves the collection of biomaterials (blood and urine). Discussion: The study aims to enhance understanding of the clinical progression and outcomes in patients with fractures in the vertebrae or pelvis. [ABSTRACT FROM AUTHOR]

Background Older people with cognitive impairment (CI) are at high risk for mobility limitations and adverse outcomes after discharge from geriatric rehabilitation settings. The aim was to estimate the effects of a specifically designed home-based physical training and activity promotion program on physical capacity, different aspects of physical activity (PA), and psychosocial status. Methods Patients with mild to moderate CI (Mini-Mental State Examination [MMSE]: 17–26 points) discharged home after rehabilitation were included in this randomized, double-blind, placebo-controlled trial with a 12-week intervention and 12-week follow-up period. The intervention group performed a CI-specific, autonomous, home-based strength, balance, and walking training supported by tailored motivational strategies to foster training adherence and promote PA. The control group participated in an unspecific motor placebo activity. Primary outcomes were physical capacity (Short Physical Performance Battery [SPPB]) and PA (sensor-based activity time). Results Among 118 randomized participants (82.3 ± 6.0 years) with CI (MMSE: 23.3 ± 2.4) and high levels of multimorbidity, those participants undergoing home-based training demonstrated superior outcomes to the control group in SPPB (mean difference between groups 1.9 points; 95% CI: 1.0–2.8; p <.001), with persistent benefits over the follow-up (1.3 points; 95% CI: 0.4–2.2; p <.001). There were no differences in PA across any time points. Among secondary outcomes, fear of falling and activity avoidance behavior were reduced in the intervention group at all time points, life-space mobility improved short-term. Conclusions The results demonstrate clinically important benefits of an individually tailored autonomous physical training and activity promotion program on physical capacity and secondary outcomes in different domains in a vulnerable, multimorbid population. Clinical Trial Registration ISRCTN82378327 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: There is a substantial lack of home-based exercise programs in the highly vulnerable group of geriatric patients with cognitive impairment (CI) after discharge from ward rehabilitation. Beyond clinical effectiveness, the cost-effectiveness of intervention programs to enhance physical performance is not well investigated in this target group. Objective: The aim of the study was to determine the cost-effectiveness of a 12-week home-based exercise intervention following discharge from ward rehabilitation compared to unspecified flexibility training for geriatric patients with CI from a societal perspective. Methods: This cost-effectiveness study was conducted alongside a randomized placebo-controlled trial. A total of 118 geriatric patients with CI (Mini-Mental State Examination score: 17–26) were randomized either to the intervention group (IG, n = 63) or control group (CG, n = 55). Participants in the IG received a home-based individually tailored exercise program to increase physical performance, while participants in the CG received unspecific flexibility training (placebo control). Healthcare service use, physical performance (Short Physical Performance Battery, SPPB), and quality of life (EQ-5D-3L) were measured over 24 weeks. The net monetary benefit (NMB) approach was applied to calculate incremental cost-effectiveness of the exercise intervention compared to the CG with respect to improvement of (a) physical performance on the SPPB and (b) quality-adjusted life years (QALYs). Results: Physical performance was significantly improved in the IG compared to the CG (mean difference at 24 weeks: 1.3 points; 95% confidence interval [95% CI] = 0.5–2.2; p = 0.003), while health-related quality of life did not significantly differ between the groups at 24 weeks (mean difference: 0.08; 95% CI = −0.05 to 0.21; p = 0.218). Mean costs to implement the home-based exercise intervention were EUR 284 per patient. The probability of a positive incremental NMB of the intervention reached a maximum of 92% at a willingness to pay (WTP) of EUR 500 per point on the SPPB. The probability of cost-utility referring to QALYs was 85% at a WTP of EUR 5,000 per QALY. Conclusion: The home-based exercise intervention demonstrated high probability of cost-effectiveness in terms of improved physical performance in older adults with CI following discharge from ward rehabilitation, but not in terms of quality of life. [ABSTRACT FROM AUTHOR]