AzTrials
AzTrials

Fall PreventionLiFE-is-LiFENCT03462654

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

A study testing iLiFE and gLiFE in people with Fall Prevention and Exercise, run by Heidelberg University at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Fall Prevention, Exercise
What is being tested?
iLiFE and gLiFE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
2 sitesGermany
Study dates
5 Apr 2018to 30 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
  • Heart failure New York Heart Function Assessment (NYHA) class III and IV
  • Recent cerebrovascular accident (<6 months)
Show all 13Show fewer
  • Parkinson's disease
  • On active cancer treatment (last 6 months)
  • Chronic Obstructive Pulmonary Disease (COPD) Gold class III and IV
  • Unstable lower limb fracture
  • Amputated lower extremity (-ies)
  • Acute treatment of depression
  • Uncontrolled resting blood pressures of a systolic >160 or diastolic >100 or higher

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Heidelberg University, Network Aging Research

    Heidelberg, 69115

  • Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation

    Stuttgart, 70376

Other trials in Germany

About this study

Official title: 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).

Read the 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).

Being tested
iLiFE, gLiFE
Keywords
Health promotion, Behaviour change, Physical activity, Fall prevention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iLiFEBehavioural

    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.

  • gLiFEBehavioural

    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.

Study groups in NCT03462654
Study groupRoleWhat they receive
individual LiFE (iLiFE)Active comparatorIn 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.
Receives: Behavioral: iLiFE
group LiFE (gLiFE)ExperimentalIn 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.
Receives: Behavioral: gLiFE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Change; baseline, 6 months, 12 months

  2. Cost-effectiveness of iLiFE and gLiFE

    Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE

    Measured: Change; baseline, 6 months, 12 months

Secondary outcomes (28)

  1. Accelerometer-collected physical activity (duration)

    Duration of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors

    Measured: Change; baseline, 6 months, 12 months

  2. Accelerometer-collected physical activity (percentage)

    Percentage of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors

    Measured: Change; baseline, 6 months, 12 months

  3. Accelerometer-collected physical activity (intensity)

    Intensity of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors

    Measured: Change; baseline, 6 months, 12 months

  4. Adherence to LiFE activities

    Exercise Adherence Rating Scale (EARS) filled out every month in a calendar

    Measured: Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up

  5. Self-reported function and disability

    Late-Life Function and Disability Instrument (LLFDI)

    Measured: Change; baseline, 6 months, 12 months

  6. Static balance (a)

    8 Level Balance Scale

    Measured: Change; baseline, 6 months, 12 months

  7. Static balance (b)

    Instrumented Tandem Stance

    Measured: Change; baseline, 6 months, 12 months

  8. Gait speed

    instrumented walking test (4m and 7m walk at usual and fast pace)

    Measured: Change; baseline, 6 months, 12 months

  9. Functional leg strength (a)

    Instrumented 30 second Chair Stand

    Measured: Change; baseline, 6 months, 12 months

  10. Functional leg strength (b)

    Instrumented Timed Up-and-Go

    Measured: Change; baseline, 6 months, 12 months

  11. Handgrip strength

    JAMAR dynamometer

    Measured: Change; baseline, 6 months, 12 months

  12. Cognitive status

    Montreal Cognitive Assessment Tool (MoCA)

    Measured: Change; baseline, 6 months, 12 months

  13. Balance confidence

    Activities-specific Balance Confidence Scale (ABC-Scale)

    Measured: Change; baseline, 6 months, 12 months

  14. Fear of falling

    Short Falls Efficacy Scale-International (Short FES-I)

    Measured: Change; baseline, 6 months, 12 months

  15. Health status (a)

    EQ-5D-5L

    Measured: Change; baseline, 6 months, 12 months

  16. Health status (b)

    EQ-VAS

    Measured: Change; baseline, 6 months, 12 months

  17. Health-related resource use

    questionnaire for the use of medical and non-medical services in old age (FIMA)

    Measured: Change; baseline, 6 months, 12 months

  18. Depressive Symptoms

    10 Item Center for Epidemiological Studies - Depression (CES-D-10)

    Measured: Change; baseline, 6 months, 12 months

  19. Subjective age

    Subjectively felt age in years

    Measured: Change; baseline, 6 months, 12 months

  20. Habit strength

    Self-Report Behavioural Automaticity Index (SRBAI)

    Measured: Change; baseline, 6 months, 12 months

  21. Motivational quality

    Behavioural Regulation in Exercise Questionnaire (BRE-Q-3)

    Measured: Change; baseline, 12 months

  22. Health Action Process Approach (HAPA) - Int

    Intention (2 items, 6-point Likert scale)

    Measured: Change; baseline, 6 months, 12 months

  23. Health Action Process Approach (HAPA) - SE

    Self-efficacy (6 items, 6-point Likert scale)

    Measured: Change; baseline, 6 months, 12 months

  24. Health Action Process Approach (HAPA) - ACP

    Action and coping planning (6 items, 6-point Likert scale)

    Measured: Change; baseline, 6 months, 12 months

  25. Health Action Process Approach (HAPA) - IAC

    Individual action control (3 items, 6-point Likert scale)

    Measured: Change; baseline, 6 months, 12 months

  26. Social support

    Loneliness Scale

    Measured: Change; baseline, 6 months, 12 months

  27. Group cohesion

    Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German)

    Measured: Change; baseline, 6 months, 12 months

  28. Evaluation of the LiFE program

    10 questions regarding quality and acceptance of as well as satisfaction with the program (6-point Likert scale)

    Measured: Change; after the last intervention session, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start5 Apr 2018
  3. Primary completion5 Aug 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into either the iLiFE or gLiFE arm of the study.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03462654
Sponsor's protocol ID
01GL1705A-D
Acronym
LiFE-is-LiFE
Status last verified
Aug 2022
First submitted
26 Feb 2018
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dams J, Gottschalk S, Schwenk M, Nerz C, Becker C, Klenk J, Jansen CP, Konig HH. 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. BMC Geriatr. 2024 Feb 23;24(1):186. doi: 10.1186/s12877-024-04802-y.

    PubMed 38395743

  • 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.

    PubMed 35509348

  • 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.

    PubMed 34479573

  • 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.

    PubMed 33522904

  • 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.

    PubMed 30400832

Questions about this trial

What is this clinical trial studying?

A study testing iLiFE and gLiFE in people with Fall Prevention and Exercise, run by Heidelberg University at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fall incidence expressed as number of falls per amount of physical activity (time frame: Change; baseline, 6 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03462654, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in