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

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

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).

Study Overview

• Status: Completed
• Conditions: Exercise; Fall Prevention
• Intervention / Treatment: Behavioral: iLiFE; Behavioral: gLiFE

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69115
    • Heidelberg University, Network Aging Research
  • Stuttgart, Germany, 70376
    • Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 70 years or older
• Speaks German language
• Able to read newspaper
• Able to walk 200 meters with or without walking aid
• Home-dwelling
• Two or more falls in the past 12 months OR one injurious fall in the past 12 months OR subjective decline in balance and strength in the past 12 months together with Timed Up-and-Go time >13.5 seconds
• Available for intervention participation for 11 weeks

Exclusion Criteria:

• Cognitive impairment (MoCA <23)
• Current participation in an organised exercise class >1 per week in the past 3 months
• Moderate to vigorous-intensity physical activity ≥150 min/week in the past 3 months

• Medical conditions:

  1. Heart failure New York Heart Function Assessment (NYHA) class III and IV
  2. Recent cerebrovascular accident (<6 months)
  3. Parkinson's disease
  4. On active cancer treatment (last 6 months)
  5. Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
  6. Unstable lower limb fracture
  7. Amputated lower extremity (-ies)
  8. Acute treatment of depression
  9. Uncontrolled resting blood pressures of a systolic >160 or diastolic >100 or higher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: individual LiFE (iLiFE); In iLiFE, LiFE activities to increase strength, improve balance, and promote physical activity as well as habitualization strategies are introduced and taught in 7 highly individualized, one-to-one home visits.	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.
EXPERIMENTAL: group LiFE (gLiFE); In gLiFE, the same LiFE activities as performed in iLiFE are introduced and taught in 7 group sessions with 8 to 12 participants. Implementation and habitualization strategies will be addressed within the group setting, making use of group dynamics and processes.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall incidence expressed as number of falls per amount of physical activity	Falls are assessed using a fall calendar; Physical activity is assessed using activPAL accelerometers	Change; baseline, 6 months, 12 months
Cost-effectiveness of iLiFE and gLiFE	Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE	Change; baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer-collected physical activity (duration)	Duration of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors	Change; baseline, 6 months, 12 months
Accelerometer-collected physical activity (percentage)	Percentage of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors	Change; baseline, 6 months, 12 months
Accelerometer-collected physical activity (intensity)	Intensity of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors	Change; baseline, 6 months, 12 months
Adherence to LiFE activities	Exercise Adherence Rating Scale (EARS) filled out every month in a calendar	Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up
Self-reported function and disability	Late-Life Function and Disability Instrument (LLFDI)	Change; baseline, 6 months, 12 months
Static balance (a)	8 Level Balance Scale	Change; baseline, 6 months, 12 months
Static balance (b)	Instrumented Tandem Stance	Change; baseline, 6 months, 12 months
Gait speed	instrumented walking test (4m and 7m walk at usual and fast pace)	Change; baseline, 6 months, 12 months
Functional leg strength (a)	Instrumented 30 second Chair Stand	Change; baseline, 6 months, 12 months
Functional leg strength (b)	Instrumented Timed Up-and-Go	Change; baseline, 6 months, 12 months
Handgrip strength	JAMAR dynamometer	Change; baseline, 6 months, 12 months
Cognitive status	Montreal Cognitive Assessment Tool (MoCA)	Change; baseline, 6 months, 12 months
Balance confidence	Activities-specific Balance Confidence Scale (ABC-Scale)	Change; baseline, 6 months, 12 months
Fear of falling	Short Falls Efficacy Scale-International (Short FES-I)	Change; baseline, 6 months, 12 months
Health status (a)	EQ-5D-5L	Change; baseline, 6 months, 12 months
Health status (b)	EQ-VAS	Change; baseline, 6 months, 12 months
Health-related resource use	questionnaire for the use of medical and non-medical services in old age (FIMA)	Change; baseline, 6 months, 12 months
Depressive Symptoms	10 Item Center for Epidemiological Studies - Depression (CES-D-10)	Change; baseline, 6 months, 12 months
Subjective age	Subjectively felt age in years	Change; baseline, 6 months, 12 months
Habit strength	Self-Report Behavioural Automaticity Index (SRBAI)	Change; baseline, 6 months, 12 months
Motivational quality	Behavioural Regulation in Exercise Questionnaire (BRE-Q-3)	Change; baseline, 12 months
Health Action Process Approach (HAPA) - Int	Intention (2 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - SE	Self-efficacy (6 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - ACP	Action and coping planning (6 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Health Action Process Approach (HAPA) - IAC	Individual action control (3 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Social support	Loneliness Scale	Change; baseline, 6 months, 12 months
Group cohesion	Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German)	Change; baseline, 6 months, 12 months
Evaluation of the LiFE program	10 questions regarding quality and acceptance of as well as satisfaction with the program (6-point Likert scale)	Change; after the last intervention session, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: German Federal Ministry of Education and Research; University of Ulm; Universitätsklinikum Hamburg-Eppendorf; Robert Bosch Gesellschaft für Medizinische Forschung mbH
• Investigators: Principal Investigator: Michael Schwenk, PhD, Network Aging Research

Publications and helpful links

General Publications

• Nerz C, Kramer-Gmeiner F, Jansen CP, Labudek S, Klenk J, Becker C, Schwenk M. Group-Based and Individually Delivered LiFE: Content Evaluation and Predictors of Training Response - A Dose-Response Analysis. Clin Interv Aging. 2022 Apr 27;17:637-652. doi: 10.2147/CIA.S359150. eCollection 2022.
• Jansen CP, Nerz C, Labudek S, Gottschalk S, Kramer-Gmeiner F, Klenk J, Dams J, Konig HH, Clemson L, Becker C, Schwenk M. Lifestyle-integrated functional exercise to prevent falls and promote physical activity: Results from the LiFE-is-LiFE randomized non-inferiority trial. Int J Behav Nutr Phys Act. 2021 Sep 3;18(1):115. doi: 10.1186/s12966-021-01190-z.
• Reicherzer L, Kramer-Gmeiner F, Labudek S, Jansen CP, Nerz C, Nystrand MJ, Becker C, Clemson L, Schwenk M. Group or individual lifestyle-integrated functional exercise (LiFE)? A qualitative analysis of acceptability. BMC Geriatr. 2021 Feb 1;21(1):93. doi: 10.1186/s12877-020-01991-0.
• Jansen CP, Nerz C, Kramer F, Labudek S, Klenk J, Dams J, Konig HH, Clemson L, Becker C, Schwenk M. Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial. BMC Geriatr. 2018 Nov 6;18(1):267. doi: 10.1186/s12877-018-0953-6.

Helpful Links

• Project homepage

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2018
• Primary Completion (ACTUAL): August 5, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Health promotion; Physical activity; Fall prevention; Behaviour change
• Other Study ID Numbers: 01GL1705A-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No