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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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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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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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Hypotensive Drugs and Syncope Due to Orthostatic Hypotension in Older Adults with Dementia (Syncope and Dementia Study).
Testa, G, Ceccofiglio, A, Mussi, C, Bellelli, G, Nicosia, F, Bo, M, Riccio, D, Curcio, F, Martone, AM, Noro, G, et al
Journal of the American Geriatrics Society. 2018;(8):1532-1537
Abstract
OBJECTIVES To determine whether hypotensive drugs may play a pivotal role in inducing orthostatic hypotension (OH)-related syncope. DESIGN Prospective, observational, multicenter study. SETTING Acute care wards, syncope units, and centers for the diagnosis of dementia. PARTICIPANTS Individuals aged 65 and older with a diagnosis of dementia and 1 or more episodes of transient loss of consciousness of a suspected syncopal nature or unexplained falls during the previous 3 months MEASUREMENTS Blood pressure was measured in the supine position and in the orthostatic position after 1 and 3 minutes. OH was defined as a decrease in systolic blood pressure of 20 mmHg or more and in diastolic blood pressure of 10 mmHg or more within 3 minutes of standing. Univariate and multivariate analyses were used to evaluate associations between hypotensive drugs and their combinations with OH-related syncope. RESULTS The mean age of the study population (n=522; women, n=324) was 83.5±6.1, and the most frequent comorbidity was arterial hypertension (74.5%); 324 (67.8%) participants had had a syncopal fall and 168 (32.2%) a nonsyncopal fall. The mean number of hypotensive drugs administered (2.9±3.1) did not differ between the two groups. Syncopal falls was OH-related in 170 participants (48.0%). OH-related syncopal falls were more frequent in participants receiving nitrates (15.3% vs 9.8%, p=.06), alpha-blockers (16.5% vs 9.8%, p=.04), or combinations of angiotensin-converting enzyme inhibitors (ACE-Is) and diuretics (20.6% vs 13.0%, p=.04), alpha-blockers and diuretics (8.2% vs 3.3%, p=0.036), and ACE-Is and nitrates (8.2% vs 3.3%, p=.10). Multivariate analysis confirmed a greater risk of OH-related syncopal fall for nitrates (relative risk (RR)=1.77), combinations of ACE-Is and diuretics (RR=1.66), and combinations of ACE-Is and nitrates (RR=2.32). CONCLUSION In older adults with dementia, OH-related syncopal falls are significantly related to treatment with nitrates, combinations of ACE-Is and diuretics, and combinations of ACE-Is and nitrates.
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A falls prevention programme to improve quality of life, physical function and falls efficacy in older people receiving home help services: study protocol for a randomised controlled trial.
Bjerk, M, Brovold, T, Skelton, DA, Bergland, A
BMC health services research. 2017;(1):559
Abstract
BACKGROUND Falls and fall-related injuries in older adults are associated with great burdens, both for the individuals, the health care system and the society. Previous research has shown evidence for the efficiency of exercise as falls prevention. An understudied group are older adults receiving home help services, and the effect of a falls prevention programme on health-related quality of life is unclear. The primary aim of this randomised controlled trial is to examine the effect of a falls prevention programme on quality of life, physical function and falls efficacy in older adults receiving home help services. A secondary aim is to explore the mediating factors between falls prevention and health-related quality of life. METHODS The study is a single-blinded randomised controlled trial. Participants are older adults, aged 67 or older, receiving home help services, who are able to walk with or without walking aids, who have experienced at least one fall during the last 12 months and who have a Mini Mental State Examination of 23 or above. The intervention group receives a programme, based on the Otago Exercise Programme, lasting 12 weeks including home visits and motivational telephone calls. The control group receives usual care. The primary outcome is health-related quality of life (SF-36). Secondary outcomes are leg strength, balance, walking speed, walking habits, activities of daily living, nutritional status and falls efficacy. All measurements are performed at baseline, following intervention at 3 months and at 6 months' follow-up. Sample size, based on the primary outcome, is set to 150 participants randomised into the two arms, including an estimated 15-20% drop out. Participants are recruited from six municipalities in Norway. DISCUSSION This trial will generate new knowledge on the effects of an exercise falls prevention programme among older fallers receiving home help services. This knowledge will be useful for clinicians, for health managers in the primary health care service and for policy makers. TRIAL REGISTRATION ClinicalTrials.gov . NCT02374307 . First registration, 16/02/2015.
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Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study).
Gill, TM, Pahor, M, Guralnik, JM, McDermott, MM, King, AC, Buford, TW, Strotmeyer, ES, Nelson, ME, Sink, KM, Demons, JL, et al
BMJ (Clinical research ed.). 2016;:i245
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OBJECTIVE To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. DESIGN Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). SETTING Eight centers across the United States, February 2010 to December 2011. PARTICIPANTS 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m. INTERVENTIONS A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. MAIN OUTCOME MEASURES Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. RESULTS Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). CONCLUSIONS In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500.
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Functional Impairments Mediate Association Between Clinical Fracture Risk and Type 2 Diabetes Mellitus in Older Women.
Lee, RH, Pieper, CF, Colón-Emeric, C
Journal of the American Geriatrics Society. 2015;(8):1546-51
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OBJECTIVES To examine the effect of functional impairments in older women with diabetes mellitus (DM) on incident clinical fractures. DESIGN Secondary analysis of two large prospective cohort studies. SETTING North Carolina Established Populations for Epidemiologic Studies of the Elderly (EPESE) and Women's Health Initiative (WHI) clinical trials. PARTICIPANTS EPESE included 2,704 community-dwelling women aged 65 and older; WHI clinical trials included 68,125 postmenopausal women. MEASUREMENTS Women with DM at baseline were compared with women without in successive Cox proportional hazards models. Functional limitations were determined according to self-reported difficulties with activities of daily living (ADLs) and physical activities. RESULTS The risk of any clinical fracture during the study period was greater in women with DM, after controlling for age, race and ethnicity, and body mass index, in the EPESE (hazard ratio (HR) = 1.36, 95% confidence interval (CI) = 1.08-1.72) and WHI (HR = 1.29, 95% CI = 1.19-1.39) cohorts. After inclusion of functional limitations, the greater risk of fracture associated with DM decreased in the EPESE (HR = 1.25, 95% CI = 0.98-1.59) and WHI (HR = 1.21, 95% CI = 1.12-1.31) cohorts. In participants with DM, difficulties with moderate physical activities, such as bending or stooping, walking several blocks, and heavy housework, were significantly associated with incident fracture (P < .05). CONCLUSION Older women with DM are at greater risk of clinical fractures than those without, independent of bone mineral density. Greater functional impairment in moderate physical activities mediates this greater fracture risk in part, although there remains an unexplained residual DM-associated risk for fracture.
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Effectiveness of a primary care based multifactorial intervention to improve frailty parameters in the elderly: a randomised clinical trial: rationale and study design.
Romera, L, Orfila, F, Segura, JM, Ramirez, A, Möller, M, Fabra, ML, Lancho, S, Bastida, N, Foz, G, Fabregat, MA, et al
BMC geriatrics. 2014;:125
Abstract
BACKGROUND Frailty is a highly prevalent condition in old age leading to vulnerability and greater risk of adverse health outcomes and disability. Detecting and tackling frailty at an early stage can prevent disability. The purpose of this study is to evaluate the effectiveness of a multifactorial intervention program to modify frailty parameters, muscle strength, and physical and cognitive performance in people aged 65 years or more. It also assesses changes from baseline in falls, hospitalizations, nutritional risk, disability, institutionalization, and home-care. METHODS/DESIGN The current study is a randomised single-blind, parallel-group clinical trial, with a one and a half year follow-up, conducted in eight Primary Health Care Centres located in the city of Barcelona. Inclusion criteria are to be aged 65 years or older with positive frailty screening, timed get-up-and-go test between 10 to 30 seconds, and Cognition Mini-Exam (MEC-35) of Lobo greater than or equal to 18. A total of 352 patients have been equally divided into two groups: intervention and control. Sample size calculated to detect a 0.5 unit difference in the Short Physical Performance Battery (Common SD: 1.42, 20% lost to follow-up). In the intervention group three different actions on frailty dimensions: rehabilitative therapy plus intake of hyperproteic nutritional shakes, memory workshop, and medication review are applied to sets of 16 patients. Participants in both intervention and control groups receive recommendations on nutrition, healthy lifestyles, and home risks.Evaluations are blinded and conducted at 0, 3, and 18 months. Intention to treat analyses will be performed. Multivariate analysis will be carried out to assess time changes of dependent variables. DISCUSSION It is expected that this study will provide evidence of the effectiveness of a multidisciplinary intervention on delaying the progression from frailty to disability in the elderly. It will help improve the individual's quality of life and also reduce the rates of falls, hospital admissions, and institutionalizations, thus making the health care system more efficient. This preventive intervention can be adapted to diverse settings and be routinely included in Primary Care Centres as a Preventive Health Programme. TRIAL REGISTRATION ClinicalTrials.gov PRS: NCT01969526. Date of registration: 10/21/2013.
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Does increased sunlight exposure work as a strategy to improve vitamin D status in the elderly: a cluster randomised controlled trial.
Sambrook, PN, Cameron, ID, Chen, JS, Cumming, RG, Durvasula, S, Herrmann, M, Kok, C, Lord, SR, Macara, M, March, LM, et al
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2012;(2):615-24
Abstract
SUMMARY Sunlight exposure by improving vitamin D status could be a simple public health strategy in reducing falls among frail elder people. In a randomised controlled trial, adherence to sunlight exposure was low (median adherence, 26%) and no effect of increased UV exposure on falls risk was observed (incidence rate ratio (IRR) 1.06, P = 0.73). INTRODUCTION This study aimed to determine whether increased sunlight exposure was effective to improve vitamin D status and reduce falls in the elderly. METHODS In a cluster randomised controlled trial (NCT00322166 at ClinicalTrials.gov), 602 residents aged 70 or more (mean age, 86.4 years; 71% female) were recruited from 51 aged care facilities in Northern Sydney, Australia. Participants were randomised by facility to receive either increased sunlight exposure (additional 30-40 min/day in the early morning) with (UV+) or without (UV) calcium supplementation (600 mg/day) or neither (control) for a year. The co-primary endpoints were change in serum 25 hydroxy vitamin D (25OHD) and falls incidence after 12 months. RESULTS Adherence to sunlight exposure was low (median adherence, 26%; IQR, 7%-45%). Serum 25OHD levels were low at baseline (median, 32.9 nmol/L) and increased only slightly depending on the number of sunlight sessions attended over 12 months (P = 0.04). During the study, 327 falls occurred in 111 (54%) subjects in the control group, 326 falls in 111 (58%) subjects in the UV only group and 335 falls in 108 (52%) subjects in the UV+ group. By intention-to-treat analysis, there was no significant effect of increased UV exposure on falls risk (IRR, 1.06; 95% CI, 0.76-1.48; P = 0.73). However, in 66 participants who attended ≥130 sessions per year (adherence, ≥50% of 260 sessions-five per week), falls were significantly reduced (IRR, 0.52; 95% CI, 0.31-0.88; P = 0.01) compared with the control group. CONCLUSIONS Increased sunlight exposure did not reduce vitamin D deficiency or falls risk in frail older people. This public health strategy was not effective most likely due to poor adherence to the intervention.
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Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial.
Clemson, L, Fiatarone Singh, MA, Bundy, A, Cumming, RG, Manollaras, K, O'Loughlin, P, Black, D
BMJ (Clinical research ed.). 2012;:e4547
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OBJECTIVES To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home. DESIGN Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website. SETTING Residents in metropolitan Sydney, Australia. PARTICIPANTS Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran's Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises. INTERVENTIONS Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months. MAIN OUTCOME MEASURES Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass. RESULTS After 12 months' follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls. CONCLUSIONS The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity. TRIAL REGISTRATION Australia and New Zealand Clinical Trials Registry 12606000025538.
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Effects of a long-term vitamin D and calcium supplementation on falls and parameters of muscle function in community-dwelling older individuals.
Pfeifer, M, Begerow, B, Minne, HW, Suppan, K, Fahrleitner-Pammer, A, Dobnig, H
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 2009;(2):315-22
Abstract
UNLABELLED In 242 community-dwelling seniors, supplementation with either 1000 mg of calcium or 1000 mg of calcium plus vitamin D resulted in a decrease in the number of subjects with first falls of 27% at month 12 and 39% at month 20. Additionally, parameters of muscle function improved significantly. INTRODUCTION The efficacy of vitamin D and calcium supplementation on risk of falling in the elderly is discussed controversially. Randomized controlled trials using falls as primary outcome are needed. We investigated long-term effects of calcium and vitamin D on falls and parameters of muscle function in community-dwelling elderly women and men. METHODS Our study population consisted of 242 individuals recruited by advertisements and mailing lists (mean [ +/- SD] age, 77 +/- 4 years). All serum 25-hydroxyvitamin D (25[OH]D) levels were below 78 nmol/l. Individuals received in a double blinded fashion either 1000 mg of calcium or 1000 mg of calcium plus 800 IU of vitamin D per day over a treatment period of 12 months, which was followed by a treatment-free but still blinded observation period of 8 months. Falls were documented using diaries. The study took place in Bad Pyrmont, Germany (latitude 52 degrees ) and Graz, Austria (latitude 46 degrees ). RESULTS Compared to calcium mono, supplementation with calcium plus vitamin D resulted in a significant decrease in the number of subjects with first falls of 27% at month 12 (RR = 0.73; CI = 0.54-0.96) and 39% at month 20 (RR = 0.61; CI = 0.34-0.76). Concerning secondary endpoints, we observed significant improvements in quadriceps strength of 8%, a decrease in body sway of 28%, and a decrease in time needed to perform the TUG test of 11%. DISCUSSION Combined calcium and vitamin D supplementation proved superior to calcium alone in reducing the number of falls and improving muscle function in community-dwelling older individuals.