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

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2021
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Jansen, Carl-Philipp
Nerz, Corinna
Labudek, Sarah
Gottschalk, Sophie
Kramer-Gmeiner, Franziska
Klenk, Jochen
Dams, Judith
König, Hans-Helmut
Clemson, Lindy
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International Journal of Behavioral Nutrition and Physical Activity. BioMed Central. 2021, 18(1), 115. eISSN 1479-5868. Available under: doi: 10.1186/s12966-021-01190-z
Zusammenfassung

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.

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796 Sport
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Fall prevention, Non-inferiority trial, Fall risk, Intervention costs, Physical activity promotion
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ISO 690JANSEN, Carl-Philipp, Corinna NERZ, Sarah LABUDEK, Sophie GOTTSCHALK, Franziska KRAMER-GMEINER, Jochen KLENK, Judith DAMS, Hans-Helmut KÖNIG, Lindy CLEMSON, Michael SCHWENK, 2021. Lifestyle-integrated functional exercise to prevent falls and promote physical activity : Results from the LiFE-is-LiFE randomized non-inferiority trial. In: International Journal of Behavioral Nutrition and Physical Activity. BioMed Central. 2021, 18(1), 115. eISSN 1479-5868. Available under: doi: 10.1186/s12966-021-01190-z
BibTex
@article{Jansen2021Lifes-58320,
  year={2021},
  doi={10.1186/s12966-021-01190-z},
  title={Lifestyle-integrated functional exercise to prevent falls and promote physical activity : Results from the LiFE-is-LiFE randomized non-inferiority trial},
  number={1},
  volume={18},
  journal={International Journal of Behavioral Nutrition and Physical Activity},
  author={Jansen, Carl-Philipp and Nerz, Corinna and Labudek, Sarah and Gottschalk, Sophie and Kramer-Gmeiner, Franziska and Klenk, Jochen and Dams, Judith and König, Hans-Helmut and Clemson, Lindy and Schwenk, Michael},
  note={Article Number: 115}
}
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    <dcterms:abstract xml:lang="eng">Background&lt;br /&gt;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.&lt;br /&gt;&lt;br /&gt;Methods&lt;br /&gt;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.&lt;br /&gt;&lt;br /&gt;Results&lt;br /&gt;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.&lt;br /&gt;&lt;br /&gt;Conclusions&lt;br /&gt;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.</dcterms:abstract>
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