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Completed

NCT Number: NCT03462654

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

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).

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Key information

Conditions

Fall Prevention Behavior Exercise Motor Activity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heidelberg University, Network Aging Research, Heidelberg, Germany

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

iLiFE

Behavioral

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.

gLiFE

Behavioral

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.

Primary outcomes

  1. Fall incidence expressed as number of falls per amount of physical activity

    Time frame: Change; baseline, 6 months, 12 months

    Falls are assessed using a fall calendar; Physical activity is assessed using activPAL accelerometers

  2. Cost-effectiveness of iLiFE and gLiFE

    Time frame: Change; baseline, 6 months, 12 months

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

Secondary outcomes

  1. Accelerometer-collected physical activity (duration)

    Time frame: Change; baseline, 6 months, 12 months

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

  2. Accelerometer-collected physical activity (percentage)

    Time frame: Change; baseline, 6 months, 12 months

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

  3. Accelerometer-collected physical activity (intensity)

    Time frame: Change; baseline, 6 months, 12 months

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

  4. Adherence to LiFE activities

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

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

  5. Self-reported function and disability

    Time frame: Change; baseline, 6 months, 12 months

    Late-Life Function and Disability Instrument (LLFDI)

  6. Static balance (a)

    Time frame: Change; baseline, 6 months, 12 months

    8 Level Balance Scale

  7. Static balance (b)

    Time frame: Change; baseline, 6 months, 12 months

    Instrumented Tandem Stance

  8. Gait speed

    Time frame: Change; baseline, 6 months, 12 months

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

  9. Functional leg strength (a)

    Time frame: Change; baseline, 6 months, 12 months

    Instrumented 30 second Chair Stand

  10. Functional leg strength (b)

    Time frame: Change; baseline, 6 months, 12 months

    Instrumented Timed Up-and-Go

  11. Handgrip strength

    Time frame: Change; baseline, 6 months, 12 months

    JAMAR dynamometer

  12. Cognitive status

    Time frame: Change; baseline, 6 months, 12 months

    Montreal Cognitive Assessment Tool (MoCA)

  13. Balance confidence

    Time frame: Change; baseline, 6 months, 12 months

    Activities-specific Balance Confidence Scale (ABC-Scale)

  14. Fear of falling

    Time frame: Change; baseline, 6 months, 12 months

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

  15. Health status (a)

    Time frame: Change; baseline, 6 months, 12 months

    EQ-5D-5L

  16. Health status (b)

    Time frame: Change; baseline, 6 months, 12 months

    EQ-VAS

  17. Health-related resource use

    Time frame: Change; baseline, 6 months, 12 months

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

  18. Depressive Symptoms

    Time frame: Change; baseline, 6 months, 12 months

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

  19. Subjective age

    Time frame: Change; baseline, 6 months, 12 months

    Subjectively felt age in years

  20. Habit strength

    Time frame: Change; baseline, 6 months, 12 months

    Self-Report Behavioural Automaticity Index (SRBAI)

  21. Motivational quality

    Time frame: Change; baseline, 12 months

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

  22. Health Action Process Approach (HAPA) - Int

    Time frame: Change; baseline, 6 months, 12 months

    Intention (2 items, 6-point Likert scale)

  23. Health Action Process Approach (HAPA) - SE

    Time frame: Change; baseline, 6 months, 12 months

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

  24. Health Action Process Approach (HAPA) - ACP

    Time frame: Change; baseline, 6 months, 12 months

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

  25. Health Action Process Approach (HAPA) - IAC

    Time frame: Change; baseline, 6 months, 12 months

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

  26. Social support

    Time frame: Change; baseline, 6 months, 12 months

    Loneliness Scale

  27. Group cohesion

    Time frame: Change; baseline, 6 months, 12 months

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

  28. Evaluation of the LiFE program

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

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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Collaborators

  • German Federal Ministry of Education and Research
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
  • University of Ulm
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

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

Acronym: LiFE-is-LiFE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 12, 2018
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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