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Strategies and challenges associated with recruiting retirement village communities and residents into a group exercise intervention.
Duckham, RL, Tait, JL, Nowson, CA, Sanders, KM, Taaffe, DR, Hill, KD, Daly, RM
BMC medical research methodology. 2018;(1):173
Abstract
BACKGROUND Randomized controlled trials (RCTs) provide the highest level of scientific evidence, but successful participant recruitment is critical to ensure the external and internal validity of results. This study describes the strategies associated with recruiting older adults at increased falls risk residing in retirement villages into an 18-month cluster RCT designed to evaluate the effects of a dual-task exercise program on falls and physical and cognitive function. METHODS Recruitment of adults aged ≥65 at increased falls risk residing within retirement villages (size 60-350 residents) was initially designed to occur over 12 months using two distinct cohorts (C). Recruitment occurred via a three-stage approach that included liaising with: 1) village operators, 2) independent village managers, and 3) residents. To recruit residents, a variety of different approaches were used, including distribution of information pack, on-site presentations, free muscle and functional testing, and posters displayed in common areas. RESULTS Due to challenges with recruitment, three cohorts were established between February 2014 and April 2015 (14 months). Sixty retirement villages were initially invited, of which 32 declined or did not respond, leaving 28 villages that expressed interest. A total of 3947 individual letters of invitation were subsequently distributed to residents of these villages, from which 517 (13.1%) expressions of interest (EOI) were received. Across three cohorts with different recruitment strategies adopted there were only modest differences in the number of EOI received (10.5 to 15.3%), which suggests that no particular recruitment approach was most effective. Following the initial screening of these residents, 398 (77.0%) participants were deemed eligible to participate, but a final sample of 300 (58.0% of the 517 EOI) consented and was randomized; 7.6% of the 3947 residents invited. Principal reasons for not participating, despite being eligible, were poor health, lack of time and no GP approval. CONCLUSION This study highlights that there are significant challenges associated with recruiting sufficient numbers of older adults from independent living retirement villages into an exercise intervention designed to improve health and well-being. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12613001 161718 . Date registered 23rd October 2013.
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Effects of vitamin D supplementation on musculoskeletal health: a systematic review, meta-analysis, and trial sequential analysis.
Bolland, MJ, Grey, A, Avenell, A
The lancet. Diabetes & endocrinology. 2018;(11):847-858
Abstract
BACKGROUND The effects of vitamin D on fractures, falls, and bone mineral density are uncertain, particularly for high vitamin D doses. We aimed to determine the effect of vitamin D supplementation on fractures, falls, and bone density. METHODS In this systematic review, random-effects meta-analysis, and trial sequential analysis, we used findings from literature searches in previously published meta-analyses. We updated these findings by searching PubMed, Embase, and Cochrane Central on Sept 14, 2017, and Feb 26, 2018, using the search term "vitamin D" and additional keywords, without any language restrictions. We assessed randomised controlled trials of adults (>18 years) that compared vitamin D with untreated controls, placebo, or lower-dose vitamin D supplements. Trials with multiple interventions (eg, co-administered calcium and vitamin D) were eligible if the study groups differed only by use of vitamin D. We excluded trials of hydroxylated vitamin D analogues. Eligible studies included outcome data for total or hip fractures, falls, or bone mineral density measured at the lumbar spine, total hip, femoral neck, total body, or forearm. We extracted data about participant characteristics, study design, interventions, outcomes, funding sources, and conflicts of interest. The co-primary endpoints were participants with at least one fracture, at least one hip fracture, or at least one fall; we compared data for fractures and falls using relative risks with an intention-to-treat analysis using all available data. The secondary endpoints were the percentage change in bone mineral density from baseline at lumbar spine, total hip, femoral neck, total body, and forearm. FINDINGS We identified 81 randomised controlled trials (n=53 537 participants) that reported fracture (n=42), falls (n=37), or bone mineral density (n=41). In pooled analyses, vitamin D had no effect on total fracture (36 trials; n=44 790, relative risk 1·00, 95% CI 0·93-1·07), hip fracture (20 trials; n=36 655, 1·11, 0·97-1·26), or falls (37 trials; n=34 144, 0·97, 0·93-1·02). Results were similar in randomised controlled trials of high-dose versus low-dose vitamin D and in subgroup analyses of randomised controlled trials using doses greater than 800 IU per day. In pooled analyses, there were no clinically relevant between-group differences in bone mineral density at any site (range -0·16% to 0·76% over 1-5 years). For total fracture and falls, the effect estimate lay within the futility boundary for relative risks of 15%, 10%, 7·5%, and 5% (total fracture only), suggesting that vitamin D supplementation does not reduce fractures or falls by these amounts. For hip fracture, at a 15% relative risk, the effect estimate lay between the futility boundary and the inferior boundary, meaning there is reliable evidence that vitamin D supplementation does not reduce hip fractures by this amount, but uncertainty remains as to whether it might increase hip fractures. The effect estimate lay within the futility boundary at thresholds of 0·5% for total hip, forearm, and total body bone mineral density, and 1·0% for lumbar spine and femoral neck, providing reliable evidence that vitamin D does not alter these outcomes by these amounts. INTERPRETATION Our findings suggest that vitamin D supplementation does not prevent fractures or falls, or have clinically meaningful effects on bone mineral density. There were no differences between the effects of higher and lower doses of vitamin D. There is little justification to use vitamin D supplements to maintain or improve musculoskeletal health. This conclusion should be reflected in clinical guidelines. FUNDING Health Research Council of New Zealand.
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3.
Interventions to Prevent Falls in Older Adults: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.
Guirguis-Blake, JM, Michael, YL, Perdue, LA, Coppola, EL, Beil, TL
JAMA. 2018;(16):1705-1716
Abstract
IMPORTANCE Falls are the most common cause of injury-related morbidity and mortality among older adults. OBJECTIVE To systematically review literature on the effectiveness and harms of fall prevention interventions in community-dwelling older adults to inform the US Preventive Services Task Force. DATA SOURCES MEDLINE, PubMed, Cumulative Index for Nursing and Allied Health Literature, and Cochrane Central Register of Controlled Trials for relevant English-language literature published through August 2016, with ongoing surveillance through February 7, 2018. STUDY SELECTION Randomized clinical trials of interventions to prevent falls in community-dwelling adults 65 years and older. DATA EXTRACTION AND SYNTHESIS Independent critical appraisal and data abstraction by 2 reviewers. Random-effects meta-analyses using the method of DerSimonian and Laird. MAIN OUTCOMES AND MEASURES Number of falls (number of unexpected events in which a person comes to rest on the ground, floor, or lower level), people experiencing 1 or more falls, injurious falls, people experiencing injurious falls, fractures, people experiencing fractures, mortality, hospitalizations, institutionalizations, changes in disability, and treatment harms. RESULTS Sixty-two randomized clinical trials (N = 35 058) examining 7 fall prevention intervention types were identified. This article focused on the 3 most commonly studied intervention types: multifactorial (customized interventions based on initial comprehensive individualized falls risk assessment) (26 trials [n = 15 506]), exercise (21 trials [n = 7297]), and vitamin D supplementation (7 trials [n = 7531]). Multifactorial intervention trials were associated with a reduction in falls (incidence rate ratio [IRR], 0.79 [95% CI, 0.68-0.91]) but were not associated with a reduction in other fall-related morbidity and mortality outcomes. Exercise trials were associated with statistically significant reductions in people experiencing a fall (relative risk, 0.89 [95% 13 CI, 0.81-0.97]) and injurious falls (IRR, 0.81 [95% CI, 0.73-0.90]) and with a statistically nonsignificant reduction in falls (IRR, 0.87 [95% CI, 0.75-1.00]) but showed no association with mortality. Few exercise trials reported fall-related fractures. Seven heterogeneous trials of vitamin D formulations (with or without calcium) showed mixed results. One trial of annual high-dose cholecalciferol (500 000 IU), which has not been replicated, showed an increase in falls, people experiencing a fall, and injuries, while 1 trial of calcitriol showed a reduction in falls and people experiencing a fall; the remaining 5 trials showed no significant difference in falls, people experiencing a fall, or injuries. Harms of multifactorial and exercise trials were rarely reported but generally included minor musculoskeletal injuries. CONCLUSIONS AND RELEVANCE Multifactorial and exercise interventions were associated with fall-related benefit, but evidence was most consistent across multiple fall-related outcomes for exercise. Vitamin D supplementation interventions had mixed results, with a high dose being associated with higher rates of fall-related outcomes.
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4.
Promoting safe walking among older people: the effects of a physical and cognitive training intervention vs. physical training alone on mobility and falls among older community-dwelling men and women (the PASSWORD study): design and methods of a randomized controlled trial.
Sipilä, S, Tirkkonen, A, Hänninen, T, Laukkanen, P, Alen, M, Fielding, RA, Kivipelto, M, Kokko, K, Kulmala, J, Rantanen, T, et al
BMC geriatrics. 2018;(1):215
Abstract
BACKGROUND Safe and stable walking is a complex process involving the interaction of neuromuscular, sensory and cognitive functions. As physical and cognitive functions deteriorate with ageing, training of both functions may have more beneficial effects on walking and falls prevention than either alone. This article describes the study design, recruitment strategies and interventions of the PASSWORD study investigating whether a combination of physical and cognitive training (PTCT) has greater effects on walking speed, dual-task cost in walking speed, fall incidence and executive functions compared to physical training (PT) alone among 70-85-year-old community-dwelling sedentary or at most moderately physically active men and women. METHODS Community-dwelling sedentary or at most moderately physically active, men and women living in the city of Jyväskylä will be recruited and randomized into physical training (PT) and physical and cognitive training (PTCT). The 12-month interventions include supervised training sessions and home exercises. Both groups attend physical training intervention, which follows the current physical activity guidelines. The PTCT group performes also a web-based computer program targeting executive functions. Outcomes will be assessed at baseline and at 6 and 12 months thereafter. Falls data are collected during the interventions and the subsequent one-year follow-up. The primary outcome is 10-m walking speed. Secondary outcomes include 6-min walking distance, dual-task cost in walking speed, fall incidence and executive function assessed with color Stroop and Trail Making A and B tests. Explanatory outcomes include e.g. body composition and bone characteristics, physical performance, physical activity, life-space mobility, fall-related self-efficacy, emotional well-being and personality characteristics. DISCUSSION The study is designed to capture the additive and possible synergistic effects of physical and cognitive training. When completed, the study will provide new knowledge on the effects of physical and cognitive training on the prevention of walking limitations and rate of falls in older people. The expected results will be of value in informing strategies designed to promote safe walking among older people and may have a significant health and socio-economic impact. TRIAL REGISTRATION ISRCTN52388040 .
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Prevalence of vitamin D insufficiency and evidence for disease prevention in the older population.
Kühn, J, Trotz, P, Stangl, GI
Zeitschrift fur Gerontologie und Geriatrie. 2018;(5):567-572
Abstract
The prevalence of vitamin D insufficiency, usually assessed by the analysis of circulating 25-hydroxyvitamin D (25[OH])D), is very high in the aging German population. An important factor that reduces endogenous vitamin D synthesis in older persons is physical inactivity or care-dependency that limits the time spent outside. Additionally, it has been suggested that the age-dependent decline in the glomerular filtration rate is associated with a reduced production of bioactive calcitriol. As this phenomenon is not detectable by the assessment of 25(OH)D, it is necessary to analyze the level of parathyroid hormone as a marker of calcitriol function. Because 25(OH)D levels are highly correlated with an active and healthy life style, data from epidemiological studies are not necessarily suitable to elucidate the role of vitamin D in disease prevention. Recently published meta-analyses of randomized controlled trials (RCTs) showed moderate effects of vitamin D supplementation on fracture risk and found that vitamin D was more effective when administered in combination with calcium. The role of vitamin D in the prevention of falls and frailty remains unclear. Much evidence has demonstrated the beneficial effects of vitamin D on respiratory tract infections and asthma, which are very relevant health issues in the older population. To conclude, vitamin D, particularly combined with calcium, has moderately beneficial effects on the skeletal system and is useful for the prevention of respiratory tract infections.
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Effect of two different participant information sheets on recruitment to a falls trial: An embedded randomised recruitment trial.
Witham, MD, Band, MM, Price, RJG, Fulton, RL, Clarke, CL, Donnan, PT, Soiza, RL, Cvoro, V
Clinical trials (London, England). 2018;(6):551-556
Abstract
BACKGROUND/AIMS: Recruitment to trials of intervention for older people who fall is challenging. Evidence suggests that the word falls has negative connotations for older people, and this may present a barrier to engaging with trials in this area. We therefore tested whether a participant information sheet that minimised reference to falls could improve recruitment rates. METHODS We conducted a study within a trial, embedded within a randomised controlled trial of vitamin K versus placebo to improve postural sway in patients aged 65 and over with a history of falls. Potential participants were identified from primary care lists in 14 practices and were randomised to receive either a standard participant information sheet or an information sheet minimising use of the word falls, instead focussing on maintenance of health, fitness and balance. The primary outcome for this embedded trial was the proportion of responses expressing interest in participating received in each arm. Secondary outcomes were the proportion of those contacted attending a screening visit, consenting at screening, and the proportion contacted who were randomised into the main trial. RESULTS In all, 4145 invitations were sent, with an overall response rate of 444 (10.7%). In all, 2148 individuals received the new information sheet (minimising reference to falls); 1997 received the standard information sheet. There was no statistically significant difference in response rate between those individuals sent the new information sheet and those sent the standard information sheet (10.1% vs 11.4%; difference 1.3% (95% confidence interval -0.6% to 3.2%); p = 0.19). Similarly, we found no statistically significant difference between the percentage of those who attended and consented at screening in the two groups (2.1% vs 2.7%; difference 0.6% (95% confidence interval: -0.4% to 1.6%); p = 0.20), and no statistically significant difference between the percentage randomised in the two groups (2.0% vs 2.6%; difference 0.6% (95% confidence interval -0.4% to 1.6%); p = 0.20). CONCLUSIONS Use of a participant information sheet minimising reference to falls did not lead to a greater response rate in this trial targeting older people with a history of falls.
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7.
High and odd impact exercise training improved physical function and fall risk factors in community-dwelling older men.
Allison, SJ, Brooke-Wavell, K, Folland, J
Journal of musculoskeletal & neuronal interactions. 2018;(1):100-107
Abstract
UNLABELLED High impact exercise programmes can improve bone strength, but little is known about whether this type of training further benefits fracture risk by improving physical function in older people. OBJECTIVES This study investigated the influence of high impact exercise on balance, muscle function and morphology in older men. METHODS Fifty, healthy men (65-80 years) were assigned to a 6-month multidirectional hopping programme (TG) and twenty age and physical activity matched volunteers served as controls (CG). Before and after training, muscle function (hop performance, leg press and plantar- and dorsiflexion strength) and physiological determinants (muscle thickness and architecture) as well as balance control (sway path, one leg stance duration) were measured. Resting gastrocnemius medialis (GM) muscle thickness and architecture were assessed using ultrasonography. RESULTS Significant improvements in hop impulse (+12%), isometric leg-press strength (+4%) and ankle plantarflexion strength (+11%), dorsiflexor strength (+20%) were found in the TG compared to the CG (ANOVA interaction, P⟨0.05) and unilateral stance time improved over time for TG. GM muscle thickness indicated modest hypertrophy (+4%), but muscle architecture was unchanged. CONCLUSION The positive changes in strength and balance after high impact and odd impact training would be expected to improve physical function in older adults.
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The relationship between serum IGF-1, handgrip strength, physical performance and falls in elderly men and women.
van Nieuwpoort, IC, Vlot, MC, Schaap, LA, Lips, P, Drent, ML
European journal of endocrinology. 2018;(2):73-84
Abstract
OBJECTIVE Human aging is accompanied by a decrease in growth hormone secretion and serum insulin-like growth factor (IGF)-1 levels. Also, loss of muscle mass and strength and impairment of physical performance, ending in a state of frailty, are seen in elderly. We aimed to investigate whether handgrip strength, physical performance and recurrent falls are related to serum IGF-1 levels in community-dwelling elderly. DESIGN Observational cohort study (cross-sectional and prospective). METHODS We studied the association between IGF-1 and handgrip strength, physical performance and falls in participants of the Longitudinal Aging Study Amsterdam. A total of 1292 participants were included (633 men, 659 women). Serum IGF-1 levels were divided into quartiles (IGF-1-Q1 to IGF-1-Q4). Data on falls were collected prospectively for a period of 3 years. All analyses were stratified for age and physical activity and adjusted for relevant confounders. RESULTS Men with a low physical activity score in IGF-1-Q1 and IGF-1-Q2 of the younger age group had a lower handgrip strength compared to IGF-1-Q4. In younger more active males in IGF-1-Q2 physical performance was worse. Recurrent fallers were less prevalent in older, low active males with low IGF-1 levels. In females, recurrent fallers were more prevalent in older, more active females in IGF-1-Q2. IGF-1 quartile may predict changes in handgrip strength and physical performance in men and women. CONCLUSIONS Our results indicate that lower IGF-1 levels are associated with lower handgrip strength and worse physical performance, but less recurrent fallers especially in men. Associations were often more robust in IGF-1-Q2. Future studies on this topic are desirable.
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Functional Reach, Depression Scores, and Number of Medications Are Associated With Number of Falls in People With Chronic Stroke.
Alenazi, AM, Alshehri, MM, Alothman, S, Rucker, J, Dunning, K, D'Silva, LJ, Kluding, PM
PM & R : the journal of injury, function, and rehabilitation. 2018;(8):806-816
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Abstract
BACKGROUND Falls are a common adverse event among people with stroke. Previous studies investigating risk of falls after stroke have relied primarily on retrospective fall history ranging from 6-12 months recall, with inconsistent findings. OBJECTIVES To identify factors and balance assessment tools that are associated with number of falls in individuals with chronic stroke. DESIGN Secondary analysis of a randomized clinical trial. SETTING Multisite academic and clinical institutions. PARTICIPANTS Data from 181 participants with stroke (age 60.67 ± 11.77 years, post stroke 4.51 ± 4.78 years) were included. METHODS Study participants completed baseline testing and were prospectively asked about falls. A multivariate negative binomial regression was used to identify baseline predictive factors predicting falls: age, endurance (6 minute walk test), number of medications, motor control (Fugl-Meyer lower extremity score), depression (Patient Health Questionnaire-9), physical activity (number of steps per week), and cognition (Mini Mental Status Exam score). A second negative binomial regression analysis was used to identify baseline balance assessment scores predicting falls: gait velocity (comfortable 10 Meter Walk), Berg Balance Scale (BBS), Timed Up and Go (TUG), and Functional Reach Test (FRT). Receiver operating characteristic (ROC) and area under the curve (AUC) were used to determine the cutoff scores for significant predictors of recurrent falls. MAIN OUTCOME MEASUREMENT The number of falls during the 42-week follow-up period. RESULTS Baseline measures that significantly predicted the number of falls included increased number of medications, higher depression scores, and decreased FRT. Cutoff scores for the number of medications were 8.5 with an AUC of 0.68. Depression scores differentiated recurrent fallers at a threshold of 2.5 scores with an AUC of 0.62. FRT differentiated recurrent fallers at a threshold of 18.15 cm with an AUC of 0.66. CONCLUSIONS Number of medications, depression scores, and decreased FRT distance at baseline were associated with increased number of falls. Increased medications might indicate multiple comorbidities or polypharmacy effect; increased depression scores may indicate psychological status; and decreased functional reach distance could indicate dynamic balance impairments. LEVEL OF EVIDENCE II.
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A Systematic Review and Meta-Analyses of the Association Between Anti-Hypertensive Classes and the Risk of Falls Among Older Adults.
Ang, HT, Lim, KK, Kwan, YH, Tan, PS, Yap, KZ, Banu, Z, Tan, CS, Fong, W, Thumboo, J, Ostbye, T, et al
Drugs & aging. 2018;(7):625-635
Abstract
BACKGROUND Falls in individuals aged ≥ 60 years may result in injury, hospitalisation or death. The role of anti-hypertensive medications in falls among older adults is unclear. OBJECTIVE The objective of this study was to assess the association of six anti-hypertensive medication classes, namely α-blockers (AB), angiotensin converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB), β-blockers (BB), calcium channel blockers (CCB) and diuretics, with the risk of falls, injurious falls or recurrent falls in individuals aged ≥ 60 years compared with non-users. METHODS We performed systematic searches in PubMed, EMBASE and CINAHL and included cohort, case-control and cross-sectional studies that investigated the associations between the use of anti-hypertensive medication classes and the risk of falls, injurious falls or recurrent falls in older adults (≥ 60 years) reported in English. We assessed study quality using the Newcastle-Ottawa Scale (NOS). Unadjusted and adjusted odds ratios (ORs) were pooled using random effects model. We performed meta-analyses for each anti-hypertensive medication class and each fall outcome. We also performed sensitivity analyses by pooling studies of high quality and subgroup analyses among studies with an average age of ≥ 80 years. RESULTS Seventy-eight articles (where 74, 34, 27, 18, 13 and 11 of them examined diuretics, BB, CCB, ACEi, AB and ARB, respectively) met our inclusion and exclusion criteria; we pooled estimates from 60 articles. ACEi [OR 0.85, 95% confidence interval (CI) 0.81-0.89], BB (OR 0.84, 95% CI 0.76-0.93) and CCB (OR 0.81, 95% CI 0.74-0.90) use were associated with a lower risk of injurious falls than in non-users. Results in sensitivity and subgroup analyses were largely consistent. CONCLUSION The use of ACEi, BB or CCB among older adults may be associated with a lower risk of injurious falls than non-use.