Dataset Information

Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program.

ABSTRACT: BACKGROUND:Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program-the LIVE LiFE program-for community-living older adults. The program adapts and expands the successful Lifestyle Intervention Functional Exercise (LiFE) program by adding home safety, vision contrast screening, and medication review. The specific aims of the study are to (1) adapt the LiFE program to a US context and expand it into a multicomponent program (LIVE LiFE) addressing intrinsic and extrinsic fall risks, (2) examine feasibility and acceptability, and (3) estimate program impact on multiple outcome measures to prepare for an efficacy trial. METHODS:The study involves two phases: an open-label pilot, followed by a two-group, single-blinded randomized pilot trial. Eligible participants are community-living adults 70+ years reporting at least one injurious fall or two non-injurious falls in the previous year. Participants are randomized in a 2:1 ratio to the program group (LIVE LiFE, n?=?25) or the control group (written fall risk assessment, n?=?12). The open-label pilot participants (n?=?3) receive the program without randomization and are assessed based on their experience, resulting in a stronger emphasis on the participant's personal goals being integrated into LIVE LiFE. Fall risk and balance outcomes are assessed by the Timed Up and Go and the 4-Stage Balance Test at 16?weeks. Additional outcomes are incidence of falls and near falls, falls efficacy, fear of falling, number of home hazards, and medications assessed at 16?weeks. Incidence of falls and near falls, program adherence, and satisfaction are assessed again at 32?weeks. DISCUSSION:By expanding and adapting the evidence-based LiFE program, our study will help us understand the feasibility of conducting a multicomponent program and estimate its impact on multiple outcome measures. This will support moving forward with an efficacy trial of the LIVE LiFE program for older adults who are at risk of falling. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03351413 . Registered on 22 November 2017.

SUBMITTER: Granbom M

PROVIDER: S-EPMC6318957 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program.

Granbom Marianne M Clemson Lindy L Roberts Laken L Hladek Melissa D MD Okoye Safiyyah M SM Liu Minhui M Felix Cynthia C Roth David L DL Gitlin Laura N LN Szanton Sarah S

Trials 20190103 1

<h4>Background</h4>Falls reflect sentinel events in older adults, with significant negative consequences. Although fall risk factors have been identified as intrinsic (e.g., muscle weakness, balance problems) and extrinsic (e.g., home hazards), most prevention programs target only intrinsic factors. We present the rationale and design of a home-based multicomponent fall prevention program-the LIVE LiFE program-for community-living older adults. The program adapts and expands the successful Lifes ...[more]

PMID: 30606239

Similar Datasets

Project description:BackgroundFalls represent important drivers of intrinsic capacity losses, functional limitations and reduced quality of life in the growing older adult's population, especially among those presenting with frailty. Despite exercise- and cognitive training-based interventions have shown effectiveness for reducing fall rates, evidence around their putative cumulative effects on falls and fall-related complications (such as fractures, reduced quality of life and functional limitations) in frail individuals remains scarce. The main aim of this study is to explore the effectiveness program combining an individualized exercise program and an executive function-based cognitive training (VIVIFRAIL-COGN) compared to usual care in the prevention of falls and fall-related outcomes over a 1-year follow-up.MethodsThis study is designed as a four-center randomized clinical trial with a 12-week intervention period and an additional 1-year follow-up. Three hundred twenty frail or pre-frail (≥ 1 criteria of the Frailty Phenotype) older adults (≥ 75 years) with high risk of falling (defined by fall history and gait performance) will be recruited in the Falls Units of the participating centers. They will be randomized in a 1:1 ratio to the intervention group (IG) or the control group (CG). The IG will participate in a home-based intervention combining the individualized Vivifrail multicomponent (aerobic, resistance, gait and balance and flexibility) exercise program and a personalized executive function-based cognitive training (VIVIFRAIL-COGN). The CG group will receive usual care delivered in the Falls Units, including the Otago Exercise Program. Primary outcome will be the incidence of falls (event rate/year) and will be ascertained by self-report during three visits (at baseline, and 6 and 12 weeks) and telephone-based contacts at 6, 9 and 12 months after randomization. Secondarily, effects on measures of physical and cognitive function, quality of life, nutritional, muscle quality and psychological status will be evaluated.DiscussionThis trial will provide new evidence about the effectiveness of an individualized multidomain intervention by studying the effect of additive effects of cognitive training and physical exercise to prevent falls in older frail persons with high risk of falling. Compared to usual care, the combined intervention is expected to show additive effects in the reduction of the incidence of falls and associated adverse outcomes.Trial registrationNCT04911179 02/06/2021.

Project description:BackgroundFalls are the leading cause of fatal and non-fatal injuries among older adults. Exercise programs appear to reduce fall risk, but the optimal type, frequency, and duration of exercise is unknown. External perturbations such as tripping and slipping are a major contributor to falls, and task-specific perturbation training to enhance dynamic stability has emerged as a promising approach to modifying fall risk. The purpose of this pilot study was 1) to determine the feasibility of conducting a large pragmatic randomized trial comparing a multidimensional exercise program inclusive of the surface perturbation treadmill training (SPTT) to multidimensional exercise alone (Standard PT); and 2) to assess fall outcomes between the two groups to determine whether an effect size large enough to warrant further study might be present.MethodsA randomized pilot study at two outpatient physical therapy clinics. Participants were over age 64 and referred for gait and balance training. Feasibility for a larger randomized trial was assessed based on the ability of therapists to incorporate the SPTT into their clinical practice and acceptance of study participation by eligible patients. Falls were assessed by telephone interview 3 months after enrollment.ResultsOf 83 patients who were screened, 73 met inclusion criteria. SPTT was successfully adapted into clinical practice and 88% of eligible subjects were willing to be randomized, although 10% of the SPTT cohort dropped out prior to treatment. The SPTT group showed fewer subjects having any fall (19.23% vs. 33.33% Standard PT; p < 0.227) and fewer having an injurious fall (7.69% vs. 18.18%; p < 0.243). These results were not statistically significant but this pilot study was not powered for hypothesis testing.ConclusionsPhysical therapy inclusive of surface perturbation treadmill training appears clinically feasible, and randomization between these two PT interventions is acceptable to the majority of patients. These results appear to merit longer-term study in an adequately powered trial.Trial registrationclinicaltrials.gov: NCT01006967.

Dataset Information

Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program.

Publications

Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets