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

Exercise Clinical Trial

Official title: Comparison of a Group-delivered and Individually Delivered Lifestyle-integrated Functional Exercise (LiFE) Program in Older Persons

Status Completed

Clinical Trial 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).

Clinical Trial Description

The "Lifestyle-integrated Functional Exercise" (LiFE) program aims to promote safe indoor and outdoor mobility. It differs from classical exercise programs in that it trains and encourages participants to embed up to 15 balance and strength exercises into daily recurring tasks performed as part of the daily life routine. The LiFE program simultaneously aims at preventing falls and promoting an active lifestyle in older adults. As LiFE requires 1:1 supervision by trainers who administer LiFE exercises during seven visits in the participants' homes, it is both time consuming and resource intensive and therefore not suitable for widespread implementation. Hence, the aim of this study is to compare a group-delivered LiFE intervention (gLiFE) with the original LiFE intervention (iLiFE). More specifically, gLiFE is tested for its non-inferiority compared to iLiFE in terms of:

• Effectiveness: The gLiFE program is not less efficacious than the established iLiFE program in terms of reducing fall incidence expressed as number of falls per amount of physical activity (e.g., steps).

• Retention rate: The gLiFE program does not result in a lower intervention retention rate (i.e., percentage of the sample completing the 6-month and 12-month follow-up assessment) as compared to the iLiFE program.

• Implementation: Delivering the gLiFE program is less costly and more cost-effective than delivering the iLiFE program.

In a multicenter non-inferiority trial, participants (n = 300; > 70 years; confirmed fall or high risk of falling) will be randomized into either the individual iLiFE (seven home visits) or gLiFE (groups up to twelve persons; seven group sessions). ;

Related Conditions & MeSH terms

• Exercise
• Fall Prevention

• NCT number: NCT03462654
• Study type: Interventional
• Source: Heidelberg University
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Completion date: September 30, 2020