Comparison of a Group-delivered vs. Individually Delivered 'LiFE' Program
- Conditions
- ExerciseFall Prevention
- Interventions
- Behavioral: iLiFEBehavioral: gLiFE
- Registration Number
- NCT03462654
- Lead Sponsor
- Heidelberg University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description individual LiFE (iLiFE) 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. group LiFE (gLiFE) 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.
- Primary Outcome Measures
Name Time Method Fall incidence expressed as number of falls per amount of physical activity Change; baseline, 6 months, 12 months Falls are assessed using a fall calendar; Physical activity is assessed using activPAL accelerometers
Cost-effectiveness of iLiFE and gLiFE Change; baseline, 6 months, 12 months Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE
- Secondary Outcome Measures
Name Time Method Handgrip strength Change; baseline, 6 months, 12 months JAMAR dynamometer
Cognitive status Change; baseline, 6 months, 12 months Montreal Cognitive Assessment Tool (MoCA)
Accelerometer-collected physical activity (duration) Change; baseline, 6 months, 12 months Duration of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Accelerometer-collected physical activity (intensity) Change; baseline, 6 months, 12 months Intensity of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Static balance (a) Change; baseline, 6 months, 12 months 8 Level Balance Scale
Gait speed Change; baseline, 6 months, 12 months instrumented walking test (4m and 7m walk at usual and fast pace)
Fear of falling Change; baseline, 6 months, 12 months Short Falls Efficacy Scale-International (Short FES-I)
Health status (b) Change; baseline, 6 months, 12 months EQ-VAS
Social support Change; baseline, 6 months, 12 months Loneliness Scale
Accelerometer-collected physical activity (percentage) Change; baseline, 6 months, 12 months Percentage of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors
Adherence to LiFE activities 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
Self-reported function and disability Change; baseline, 6 months, 12 months Late-Life Function and Disability Instrument (LLFDI)
Static balance (b) Change; baseline, 6 months, 12 months Instrumented Tandem Stance
Functional leg strength (a) Change; baseline, 6 months, 12 months Instrumented 30 second Chair Stand
Motivational quality Change; baseline, 12 months Behavioural Regulation in Exercise Questionnaire (BRE-Q-3)
Health Action Process Approach (HAPA) - IAC Change; baseline, 6 months, 12 months Individual action control (3 items, 6-point Likert scale)
Group cohesion Change; baseline, 6 months, 12 months Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German)
Functional leg strength (b) Change; baseline, 6 months, 12 months Instrumented Timed Up-and-Go
Balance confidence Change; baseline, 6 months, 12 months Activities-specific Balance Confidence Scale (ABC-Scale)
Health status (a) Change; baseline, 6 months, 12 months EQ-5D-5L
Depressive Symptoms Change; baseline, 6 months, 12 months 10 Item Center for Epidemiological Studies - Depression (CES-D-10)
Subjective age Change; baseline, 6 months, 12 months Subjectively felt age in years
Habit strength Change; baseline, 6 months, 12 months Self-Report Behavioural Automaticity Index (SRBAI)
Health Action Process Approach (HAPA) - SE Change; baseline, 6 months, 12 months Self-efficacy (6 items, 6-point Likert scale)
Health Action Process Approach (HAPA) - ACP Change; baseline, 6 months, 12 months Action and coping planning (6 items, 6-point Likert scale)
Evaluation of the LiFE program 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)
Health-related resource use Change; baseline, 6 months, 12 months questionnaire for the use of medical and non-medical services in old age (FIMA)
Health Action Process Approach (HAPA) - Int Change; baseline, 6 months, 12 months Intention (2 items, 6-point Likert scale)
Trial Locations
- Locations (2)
Heidelberg University, Network Aging Research
🇩🇪Heidelberg, Germany
Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation
🇩🇪Stuttgart, Germany