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Effect of dietary sources of calcium and protein on hip fractures and falls in older adults in residential care: cluster randomised controlled trial.
Iuliano, S, Poon, S, Robbins, J, Bui, M, Wang, X, De Groot, L, Van Loan, M, Zadeh, AG, Nguyen, T, Seeman, E
BMJ (Clinical research ed.). 2021;:n2364
Abstract
OBJECTIVE To assess the antifracture efficacy and safety of a nutritional intervention in institutionalised older adults replete in vitamin D but with mean intakes of 600 mg/day calcium and <1 g/kg body weight protein/day. DESIGN Two year cluster randomised controlled trial. SETTING 60 accredited residential aged care facilities in Australia housing predominantly ambulant residents. PARTICIPANTS 7195 permanent residents (4920 (68%) female; mean age 86.0 (SD 8.2) years). INTERVENTION Facilities were stratified by location and organisation, with 30 facilities randomised to provide residents with additional milk, yoghurt, and cheese that contained 562 (166) mg/day calcium and 12 (6) g/day protein achieving a total intake of 1142 (353) mg calcium/day and 69 (15) g/day protein (1.1 g/kg body weight). The 30 control facilities maintained their usual menus, with residents consuming 700 (247) mg/day calcium and 58 (14) g/day protein (0.9 g/kg body weight). MAIN OUTCOME MEASURES Group differences in incidence of fractures, falls, and all cause mortality. RESULTS Data from 27 intervention facilities and 29 control facilities were analysed. A total of 324 fractures (135 hip fractures), 4302 falls, and 1974 deaths were observed. The intervention was associated with risk reductions of 33% for all fractures (121 v 203; hazard ratio 0.67, 95% confidence interval 0.48 to 0.93; P=0.02), 46% for hip fractures (42 v 93; 0.54, 0.35 to 0.83; P=0.005), and 11% for falls (1879 v 2423; 0.89, 0.78 to 0.98; P=0.04). The risk reduction for hip fractures and falls achieved significance at five months (P=0.02) and three months (P=0.004), respectively. Mortality was unchanged (900 v 1074; hazard ratio 1.01, 0.43 to 3.08). CONCLUSIONS Improving calcium and protein intakes by using dairy foods is a readily accessible intervention that reduces the risk of falls and fractures commonly occurring in aged care residents. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12613000228785.
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Comprehensive Interventions Including Vitamin D Effectively Reduce the Risk of Falls in Elderly Osteoporotic Patients.
Feng, F, Shi, G, Chen, H, Jia, P, Bao, L, Xu, F, Sun, QC, Tang, H
Orthopaedic surgery. 2021;(4):1262-1268
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OBJECTIVE To evaluate the effects of different intervention measures to prevent falls in elderly osteoporotic patients. METHODS A randomized controlled trial was conducted in our outpatient ward from August 2014 to September 2015. A total of 420 patients over 60 years of age were assigned to four groups. NA VitD group took 800 mg calcium and 800 IU non-active vitamin D. P-NA VitD group took 800 mg calcium, 800 IU non-active vitamin D, and received physical exercise. A VitD group took 800 mg calcium and 0.5 μg active vitamin D. P-A VitD took 800 mg calcium, 0.5 μg active vitamin D, and received physical exercise. Physical exercise includes guidance in improving muscle strength and balance ability. Short physical performance battery (SPPB), grip strength, modified falls efficacy scale (MFES), blood calcium, and 25-hydroxyl vitamin D were measured before interventions and at 3, 6, and 12 months after interventions. Bone mineral density (BMD) was detected before interventions and at 12 months after interventions. The incidence of falls and fractures, adverse events, and drug reactions were recorded for 12 months. RESULTS A total of 420 patients were allocated in the four groups: 98 cases into the NA VitD group (11 males, 87 females), 97 cases into the P-NA VitD group (13 males, 84 females), 99 cases in the A VitD group (15 males, 84 females), and 98 cases into the P-A VitD group (11 males, 87 females). At 6 months after interventions, the SPPB of A VitD group significantly increased from 6.9 ± 1.9 to 8.0 ± 2.4 (P < 0.05), and the SPPB of A VitD group significantly increased from 7.2 ± 2.1 to 8.6 ± 1.7 (P < 0.05). At 6 months after interventions, MFES of P-NA VitD group 7.0 ± 1.6 to 7.6 ± 1.6 (P < 0.05), and MFES of P-A VitD group significantly increased from 6.7 ± 1.6 to 7.5 ± 1.6 (P < 0.05). At 12 months after interventions, SPPB of all groups, grip strength, and MFES of P-NA VitD group, A VitD group, P-A VitD group were significantly improved (P < 0.05). The BMD of lumbar vertebrae of A VitD group significantly increased from 0.742 ± 0.042 to 0.776 ± 0.039, and P-A VitD group significantly increased from 0.743 ± 0.048 to 0.783 ± 0.042 (P < 0.05). No serious adverse events occurred during the 12 months of follow-up. CONCLUSION Active vitamin D is better than non-active vitamin D to improve physical ability and the BMD of lumbar vertebrae and reduce the risk of falls.
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Lifestyle-integrated functional exercise to prevent falls and promote physical activity: Results from the LiFE-is-LiFE randomized non-inferiority trial.
Jansen, CP, Nerz, C, Labudek, S, Gottschalk, S, Kramer-Gmeiner, F, Klenk, J, Dams, J, König, HH, Clemson, L, Becker, C, et al
The international journal of behavioral nutrition and physical activity. 2021;(1):115
Abstract
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.
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Fall Prevention and Anti-Osteoporosis in Osteopenia Patients of 80 Years of Age and Older: A Randomized Controlled Study.
Zhou, J, Liu, B, Qin, MZ, Liu, JP
Orthopaedic surgery. 2020;(3):890-899
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UNLABELLED To evaluate the effects of two fall-prevention and anti-osteoporotic protocols in elderly patients with osteopenia (OPA). METHODS The present randomized controlled study included patients with OPA (n =123). The age of these patients was ≥80 years old, with the mean age of 83.54 ± 2.99 years, and the male-to-female ratio was 2.97:1.00. Fall-prevention guidance was given to all patients. Patients in the experiment group (n = 62) orally received 600 mg/d of calcium carbonate, 0.5 μg/d of alfacalcidol, and 70 mg/week of alendronate, while patients in the control group (n = 61) orally received 600 mg/d of calcium carbonate and 0.5 μg/d of alfacalcidol for 18 months. The grip strength, gait speed, bone turnover markers, serum calcium, serum phosphorus, parathyroid hormone (PTH), and bone mineral density were measured, and the Timed Up and Go (TUG) test and the chair rising test (CRT) were performed. Falls, fragility fractures, medication compliance, and side effects of the drugs were recorded. RESULTS The serum levels of bone turnover markers (type I procollagen amino-terminal peptide [P1NP], type I collagen carboxyl terminal peptide [β-CTx], and osteocalcin [OC]) decreased, while the bone mineral density of the lumbar spine and bilateral femoral neck increased after treatment in the experiment group (P < 0.05, P < 0.01). The rate of change in bone mineral density of the bilateral femoral neck was higher in the experiment group than the control group (3.43% vs 0.03%, P < 0.05; 2.86% vs -0.02%, P < 0.01). After treatment, the proportion of patients with increased hip T scores in the experiment group (66.1%, 41/62) was significantly higher than the proportion (35.0%, 21/60) in the control group (P = 0.001). The incidence of fall decreased in both groups after treatment compared to that before treatment (54.8% vs 33.9% and 54.1% vs 36.7%, respectively; P < 0.05). The incidence of fragility fractures was lower in the experiment group than the control group (8.1% vs 20.0%, P = 0.057). During the intervention period, the incidence of fragility fractures in patients who did not fall (3.8%, 3/79) was significantly lower than that in patients who fell (32.6%, 14/43) (P = 0.000). The risk of fragility fractures was significantly lower in patients who did not fall compared to patients who fell (relative risk: 0.117, 95% confidence interval: 0.035-0.384). CONCLUSION The combination of alendronate sodium with alfacalcidol and calcium can significantly improve the bone mineral density of the lumbar spine and femoral neck. For older patients with OPA, subjectively paying attention to avoiding falls can significantly reduce the risk of fragility fractures.
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Multi-sensory training and wrist fractures: a randomized, controlled trial.
Baldursdottir, B, Whitney, SL, Ramel, A, Jonsson, PV, Mogensen, B, Petersen, H, Kristinsdottir, EK
Aging clinical and experimental research. 2020;(1):29-40
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BACKGROUND Asymmetric vestibular function, decreased plantar sensation, postural control and functional ability have been associated with fall-related wrist fractures. OBJECTIVE To investigate whether multi-sensory training (MST) improves postural control, vestibular function, foot sensation and functional ability among people with fall-related wrist fractures compared to wrist stabilization training (WT). METHODS This was an assessor-blinded, randomized controlled trial. Ninety-eight participants, age 50-75 years, were randomized to MST or WT. Pre- and post-training measurements: Head Shake Test (HST), Video-Head Impulse Test (vHIT), Semmes-Weinstein Monofilaments (SWF), Biothesiometer (BT), Sensory Organization Test (SOT), 10-m Walk Test (10MWT), Five Times Sit to Stand Test (FTSTS), Activities-Specific Balance Confidence (ABC) and Dizziness Handicap Inventory Scales (DHI). The training period was 12 weeks, with six supervised sessions by a physical therapist and daily home exercises for both groups. RESULTS There were significant endpoint differences in SOT (p = 0.01) between the two groups, in favor of the MST group, but no changes were seen in other outcome variables. Subgroup analysis with participants below normal baseline SOT composite scores indicated that the MST was more effective in improving 10MWT fast (p = 0.04), FTSTS (p = 0.04), SWF (p = 0.04) and SOT scores (p = 0.04) than the WT. CONCLUSIONS MST improves postural control among people with a fall-related wrist fracture. The results further suggest that the program is more effective for those with SOT balance scores below age-related norms.
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Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.
Witham, MD, Price, RJG, Band, MM, Hannah, MS, Fulton, RL, Clarke, CL, Donnan, PT, McNamee, P, Cvoro, V, Soiza, RL
Journal of the American Geriatrics Society. 2019;(10):2102-2107
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OBJECTIVES Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls. DESIGN Parallel-group double-blind randomized placebo-controlled trial. SETTING Fourteen primary care practices in Scotland, UK. PARTICIPANTS A total of 95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year. INTERVENTION Once/day placebo, 200 μg or 400 μg of oral vitamin K2 for 1 year. MEASUREMENTS The primary outcome was anteroposterior sway measured using sway plates at 12 months, adjusted for baseline. Secondary outcomes included the Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events. RESULTS Mean participant age was 75 (standard deviation [SD] = 7) years. Overall, 58 of 95 (61%) were female; 77 of 95 (81%) attended the 12-month visit. No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 μg vs placebo: -.19 cm [95% confidence interval [CI] -.68 to .30; P = .44]; 400 μg vs placebo: .17 cm [95% CI -.33 to .66; P = .50]; or 400 μg vs 200 μg: .36 cm [95% CI -.11 to .83; P = .14]). Adjusted falls rates were similar in each group. No significant treatment effects were seen for other measures of sway or secondary outcomes. Costs were higher in both vitamin K2 arms than in the placebo arm. CONCLUSION Oral vitamin K2 supplementation did not improve postural sway or physical function in older people at risk of falls. J Am Geriatr Soc 67:2102-2107, 2019.
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Overview of results from the Vitamin D Assessment (ViDA) study.
Scragg, RKR
Journal of endocrinological investigation. 2019;(12):1391-1399
Abstract
BACKGROUND The Vitamin D Assessment (ViDA) study is a randomised, double-blind, placebo-controlled trial to evaluate the efficacy of monthly vitamin D supplementation in reducing the incidence of a range of acute and chronic diseases and intermediate outcomes. METHODS The study was carried out in Auckland, New Zealand, among 5110 adults, aged 50-84 years, who were followed for a median 3.3 years. The intervention was vitamin D3 (2.5 mg or 100,000 IU) or placebo softgel oral capsules, mailed monthly to participants' homes, with two capsules sent in the first mail-out post-randomisation (i.e. 200,000 IU bolus, or placebo), followed 1 month later (and thereafter monthly) with 100,000 IU vitamin D3 or placebo capsules. Outcomes were monitored through routinely collected health data and self-completed questionnaires. RESULTS The results showed no beneficial effect of vitamin D supplementation on incidence of cardiovascular disease, falls, non-vertebral fractures and all cancer. However, beneficial effects from vitamin D supplementation were seen: for persistence with taking statins in participants on long-term statin therapy; and also in bone mineral density and arterial function in participants with low 25-hydroxyvitamin D levels, and in lung function among ever smokers (especially if vitamin D deficient). The latter findings are consistent with several previous studies, CONCLUSION Monthly high-dose vitamin D supplementation does not prevent a range of diseases, but may be beneficial for some intermediate outcomes in people who are vitamin D deficient. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry identifier: ACTRN12611000402943.
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[Physical training as core component of multimodal treatment of older frail people-study protocol of a randomized controlled pilot study].
Thiel, C, Braun, T, Grüneberg, C
Zeitschrift fur Gerontologie und Geriatrie. 2019;(1):45-60
Abstract
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 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. 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.
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Effects of moderate mountain hiking and balneotherapy on community-dwelling older people: A randomized controlled trial.
Prossegger, J, Huber, D, Grafetstätter, C, Pichler, C, Weisböck-Erdheim, R, Iglseder, B, Wewerka, G, Hartl, A
Experimental gerontology. 2019;:74-84
Abstract
BACKGROUND Population aging is one of the greatest socio-economic challenges of the 21st century, as aging is a well-known risk factor for the development of chronic diseases and functional disabilities. A sedentary life-style promotes the progression of chronic diseases and impaired mobility in older people. Therefore, physical activity is essential for healthy aging. The optimal exercise program for older persons, which covers fall prevention as well as endurance and strength, still remains unclear. METHODS We performed a longitudinal, randomized, controlled intervention study to investigate the combined effects of moderate mountain hiking and balneotherapy on gait, balance, body composition and quality of life on high-functioning people aged 65-85 years. The intervention group (n = 106) participated in a seven-day holiday with mountain hiking tours. In addition, balneotherapy was applied. The control group (n = 33) spent a typical seven-day cultural holiday with sightseeing. Medical examinations were performed before (day 0) and after the intervention week (day 7), after two months (day 60) and after half a year (day 180). Statistical analysis was done by fully nonparametric analysis of variance-type testing. RESULTS An improvement of static balance was observed in the intervention group (treatment effect p = 0.02). No significant changes were found in dynamic balance, measured as center of pressure, gait parameters and self-assessed balance confidence. Only for gait speed, a short-term effect was observed (treatment p = 0.03). The gait speed increased in the intervention group. Although quality of life improved significantly in both groups, a sustainable effect until day 60 is only visible in the intervention group (interaction effect for treatment and day-60 p = 0.02). Significant interaction effects of treatment and time were found for total body water (p = 0.04), appendicular muscle mass (p = 0.04) and fat free mass index (p = 0.03), all indicating an increase of these variables in the intervention group. CONCLUSIONS A seven-day intervention with moderate mountain hiking in combination with balneotherapy is an effective training for highly functioning older persons, inducing short-term improvements in static balance and quality of life.
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Bushen Yijing Fang Reduces Fall Risk in Late Postmenopausal Women with Osteopenia: A Randomized Double-blind and Placebo-controlled Trial.
Zheng, Y, Wang, X, Zhang, ZK, Guo, B, Dang, L, He, B, Zhang, C, Zhou, J, Shi, W, Zhao, Y, et al
Scientific reports. 2019;(1):2089
Abstract
Falls in late postmenopausal women with osteopenia usually cause fractures with severe consequences. This 36-month randomized, double-blind and placebo-controlled trial with a 10-year observational follow-up study aimed to investigate the long-term effect of herbal formula Bushen Yijing Fang (BSYJF) on fall risk in the late postmenopausal women with osteopenia. 140 late postmenopausal women (Femoral neck T-score, -2.5~-2 SD) were recruited and randomized to orally receive calcium carbonate 300 mg daily with either BSYJF or placebo for 36 months. The effect was further investigated for another 10-year follow-up. During the 36-month administration, there were 12 falls in BSYJF group and 28 falls in placebo group, respectively, indicating 64% lower risk of falls (RR 0.36 [95% CI, 0.18 to 0.71]; P = 0.004) in BSYJF group. During the 10-year follow-up, 36% lower fall risk (RR 0.64 [95% CI, 0.46 to 0.89]; P = 0.009) was observed in BSYJF group. No significant difference was found in safety profile between two groups. Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia. This clinical trial was registered at Chinese clinical trial registry (ChiCTR-IOR-16008942).