NCT03462654

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

April 5, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

February 26, 2018

Last Update Submit

August 24, 2022

Conditions

Fall PreventionExercise

Keywords

Health promotionBehaviour changePhysical activityFall prevention

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (28)

  • Accelerometer-collected physical activity (duration)

    Change; baseline, 6 months, 12 months

  • Accelerometer-collected physical activity (percentage)

    Change; baseline, 6 months, 12 months

  • Accelerometer-collected physical activity (intensity)

    Change; baseline, 6 months, 12 months

  • Adherence to LiFE activities

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

  • Self-reported function and disability

    Change; baseline, 6 months, 12 months

  • +23 more secondary outcomes

Study Arms (2)

individual LiFE (iLiFE)

ACTIVE COMPARATOR

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

group LiFE (gLiFE)

EXPERIMENTAL

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

Interventions

iLiFEBEHAVIORAL

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.

individual LiFE (iLiFE)
gLiFEBEHAVIORAL

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.

group LiFE (gLiFE)

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Heidelberg University, Network Aging Research

Heidelberg, 69115, Germany

Location

Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation

Stuttgart, 70376, Germany

Location

Related Publications (5)

  • 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.

    PMID: 38395743DERIVED

  • 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.

    PMID: 35509348DERIVED

  • 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.

    PMID: 34479573DERIVED

  • 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.

    PMID: 33522904DERIVED

  • 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.

    PMID: 30400832DERIVED

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Michael Schwenk, PhD

    Network Aging Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized into either the iLiFE or gLiFE arm of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-Doctoral Research Assistant

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 12, 2018

Study Start

April 5, 2018

Primary Completion

August 5, 2020

Study Completion

September 30, 2020

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

DE(2)