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NCT03462654: LiFE-is-LiFE

Comparison of a Group-delivered vs. Individually Delivered 'LiFE' Program

Completed NA Last updated 25 August 2022
What this trial tests

NA trial testing iLiFE in Fall Prevention in 310 participants. Completed in 30 September 2020.

Timeline
5 April 2018
Primary endpoint
5 August 2020
30 September 2020

Quick facts

Lead sponsorHeidelberg University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment310
Start date5 April 2018
Primary completion5 August 2020
Estimated completion30 September 2020
Sites2 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Heidelberg University

Who can join

70 and older, any sex, with Fall Prevention or Exercise. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the Lifestyle-Integrated Functional Exercise (LiFE) program, exercises to increase strength and improve balance are embedded into daily life activities. Recurring daily activities and tasks are used as prompts for these exercises so that they are performed multiple times per day. However, implementing the original LiFE program includes high financial requirements and human resources as it comprises one-to-one supervision of participants. Therefore, it is investigated whether implementing LiFE in groups (gLiFE) is not inferior to the individually delivered LiFE (iLiFE) in terms of reducing falls per physical activity. In addition, gLiFE is expected to be more cost-effective as compared to iLiFE. In a multicenter non-inferiority trial, 300 participants aged 70 years or older with confirmed fall risk will be randomized into either the iLiFE or gLiFE arm of the study. Both arms will undergo the same strength and balance exercises and habitualization strategies as described in the LiFE program, however, based on different approaches of delivery (i.e., group vs. individual).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Exercise for preventing falls in older people living in the community.
    Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, et al · · 2019 · cited 734× · PMID 30703272 · DOI 10.1002/14651858.cd012424.pub2
  2. 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, et al · · 2021 · cited 20× · PMID 34479573 · DOI 10.1186/s12966-021-01190-z
  3. Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial.
    Jansen CP, Nerz C, Kramer F, Labudek S, et al · · 2018 · cited 17× · PMID 30400832 · DOI 10.1186/s12877-018-0953-6
  4. Group or individual lifestyle-integrated functional exercise (LiFE)? A qualitative analysis of acceptability.
    Reicherzer L, Kramer-Gmeiner F, Labudek S, Jansen CP, et al · · 2021 · cited 12× · PMID 33522904 · DOI 10.1186/s12877-020-01991-0
  5. Association between everyday walking activity, objective and perceived risk of falling in older adults.
    Jansen CP, Klenk J, Nerz C, Todd C, et al · · 2021 · cited 8× · PMID 33710267 · DOI 10.1093/ageing/afab037
  6. Group-Based and Individually Delivered LiFE: Content Evaluation and Predictors of Training Response - A Dose-Response Analysis.
    Nerz C, Kramer-Gmeiner F, Jansen CP, Labudek S, et al · · 2022 · cited 7× · PMID 35509348 · DOI 10.2147/cia.s359150
  7. Budget impact analysis of a Lifestyle-integrated Functional Exercise (LiFE) program for older people in Germany: a Markov model based on data from the LiFE-is-LiFE trial.
    Dams J, Gottschalk S, Schwenk M, Nerz C, et al · · 2024 · cited 2× · PMID 38395743 · DOI 10.1186/s12877-024-04802-y
  8. Willingness to pay for a group and an individual version of the Lifestyle-integrated Functional Exercise program from a participant perspective.
    Gottschalk S, König HH, Schwenk M, Nerz C, et al · · 2022 · cited 2× · PMID 36258179 · DOI 10.1186/s12889-022-14322-2

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Other recruiting trials for Fall Prevention

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