Lifestyle-integrated functional exercise to prevent falls and promote physical activity: Results from the LiFE-is-LiFE randomized non-inferiority trial

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

Group-Based and Individually Delivered LiFE: Content Evaluation and Predictors of Training Response – A Dose-Response Analysis

“…Within the LiFE-is-LiFE project 14 , 26 the evidenced-based LiFE program was adapted from an individually-delivered home exercise program to a group-based format. The present study is a supplementary analysis to the main results.…”

“…The present study is a supplementary analysis to the main results. 26 Analyses of intervention content regarding LiFE activity frequency, perceived safety during LiFE program and activities, perceived degree of physical exertion (intensity) of the LiFE activities, potential for integration into daily routine as well as acceptance of both LiFE formats and subsequent changes in selected clinical outcomes like balance (8 LBS), strength (30 CS) and PA (steps/day) were carried out. To the best of our knowledge, this is the first in-depth analysis of the LiFE program content in particular but also for lifestyle-integrated prevention programs for older adults in general.…”

“…Descriptive analysis was conducted for age (in years), sex, number of fallers (fall in the last 6 months before baseline and fall frequency) and cognitive status (Montreal Cognitive Assessment score) at T 1 . Since all analyses of this paper are secondary analyses of the LiFE-is-LiFE trial 26 which was not powered for these secondary analyses no calculation of significance are carried out.…”

“… 14 , 15 , 23 Therefore, as part of the LiFE-is-LiFE project, the original LiFE program 16 was adapted into a group format (gLiFE) and tested in a pilot study 25 as well as in a randomized trial for its non-inferiority compared to the individually delivered LiFE format in reducing activity-adjusted fall incidence and intervention costs. 26 …”

“…Those results suggest that gLiFE is an attractive alternative from a payer’s and individual perspective and both formats come with important effects and benefits. 26 A detailed cost-effectiveness analysis of the LiFE-is-LiFE trial shows that the group program might be cost-effective for increasing PA but was unlikely to be cost-effective for preventing falls in older adults. 27 …”