Clinical trial NCT03462654: Comparison of a Group-delivered vs. Individually Delivered 'LiFE' Program
Official title: Comparison of a Group-delivered and Individually Delivered Lifestyle-integrated Functional Exercise (LiFE) Program in Older Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention
Exercise
Keywords: Health promotion
Behaviour change
Physical activity
Fall prevention
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: University of Ulm
name: Universitätsklinikum Hamburg-Eppendorf
name: German Federal Ministry of Education and Research
First posted: 2018-03-12
Enrollment: 310
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into either the iLiFE or gLiFE arm of the study.
Primary purpose: PREVENTION

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fall incidence expressed as number of falls per amount of physical activity
timeFrame: Change; baseline, 6 months, 12 months
measure: Cost-effectiveness of iLiFE and gLiFE
timeFrame: Change; baseline, 6 months, 12 months
Secondary outcomes:
measure: Accelerometer-collected physical activity (duration)
timeFrame: Change; baseline, 6 months, 12 months
measure: Accelerometer-collected physical activity (percentage)
timeFrame: Change; baseline, 6 months, 12 months
measure: Accelerometer-collected physical activity (intensity)
timeFrame: Change; baseline, 6 months, 12 months
measure: Adherence to LiFE activities
timeFrame: Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up
measure: Self-reported function and disability
timeFrame: Change; baseline, 6 months, 12 months
measure: Static balance (a)
timeFrame: Change; baseline, 6 months, 12 months
measure: Static balance (b)
timeFrame: Change; baseline, 6 months, 12 months
measure: Gait speed
timeFrame: Change; baseline, 6 months, 12 months
measure: Functional leg strength (a)
timeFrame: Change; baseline, 6 months, 12 months
measure: Functional leg strength (b)
timeFrame: Change; baseline, 6 months, 12 months
measure: Handgrip strength
timeFrame: Change; baseline, 6 months, 12 months
measure: Cognitive status
timeFrame: Change; baseline, 6 months, 12 months
measure: Balance confidence
timeFrame: Change; baseline, 6 months, 12 months
measure: Fear of falling
timeFrame: Change; baseline, 6 months, 12 months
measure: Health status (a)
timeFrame: Change; baseline, 6 months, 12 months
measure: Health status (b)
timeFrame: Change; baseline, 6 months, 12 months
measure: Health-related resource use
timeFrame: Change; baseline, 6 months, 12 months
measure: Depressive Symptoms
timeFrame: Change; baseline, 6 months, 12 months
measure: Subjective age
timeFrame: Change; baseline, 6 months, 12 months
measure: Habit strength
timeFrame: Change; baseline, 6 months, 12 months
measure: Motivational quality
timeFrame: Change; baseline, 12 months
measure: Health Action Process Approach (HAPA) - Int
timeFrame: Change; baseline, 6 months, 12 months
measure: Health Action Process Approach (HAPA) - SE
timeFrame: Change; baseline, 6 months, 12 months
measure: Health Action Process Approach (HAPA) - ACP
timeFrame: Change; baseline, 6 months, 12 months
measure: Health Action Process Approach (HAPA) - IAC
timeFrame: Change; baseline, 6 months, 12 months
measure: Social support
timeFrame: Change; baseline, 6 months, 12 months
measure: Group cohesion
timeFrame: Change; baseline, 6 months, 12 months
measure: Evaluation of the LiFE program
timeFrame: Change; after the last intervention session, 6 months, 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University, Network Aging Research
city: Stuttgart
country: Germany
facility: Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation
Study officials:
affiliation: Network Aging Research
name: Michael Schwenk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.