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

NCT03462654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2022-08-25

No results posted yet for this study

Summary

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).

Conditions

  • Fall Prevention
  • Exercise

Interventions

BEHAVIORAL

iLiFE

In the individual LiFE (iLiFE), the program is taught in seven visits in the individuals' homes within eleven weeks. Participants are supervised in a face to face situation by one qualified trainer (physiotherapist or sports scientist). Each home visit takes between 1 and 1.5 hours. A total of five balance exercises, seven strength exercises for the lower extremities, and two exercises to increase physical activity are taught. In addition to the home visits, all participants receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.

BEHAVIORAL

gLiFE

The group-based LiFE (gLiFE) program consists of seven group sessions (n = 8-12 participants) which are held over the course of eleven weeks, with a maximum duration of 2 hours per session. Each session is led by two qualified trainers (physio therapists or sports scientists), i.e., one main and one co-trainer. In all group sessions, trainers will teach the participants how to perform and integrate the LiFE program, i.e., LiFE balance and strength activities into their daily routines. After the group sessions have ended, participants will receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.

Sponsors & Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

    collaborator OTHER
  • University of Ulm

    collaborator OTHER
  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER
  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • Heidelberg University

    lead OTHER

Principal Investigators

  • Michael Schwenk, PhD · Network Aging Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-08-05
Completion
2020-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462654 on ClinicalTrials.gov