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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Fall Prevention, Exercise

Intervention / Treatment
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* Behavioral: iLiFE
* Behavioral: gLiFE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into either the iLiFE or gLiFE arm of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: individual LiFE (iLiFE)<br>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<br>* 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.<br>|
| Experimental: group LiFE (gLiFE)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer-collected physical activity (duration) | Duration of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors | Change; baseline, 6 months, 12 months | 
| Accelerometer-collected physical activity (percentage) | Percentage of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors | Change; baseline, 6 months, 12 months | 
| Accelerometer-collected physical activity (intensity) | Intensity of sedentary, active, and walking time during 7 days as assessed using 'activPAL' activity monitors | Change; baseline, 6 months, 12 months | 
| Adherence to LiFE activities | Exercise Adherence Rating Scale (EARS) filled out every month in a calendar | Monthly; starting from first iLiFE or gLiFE participation until the date of the 12 month follow-up | 
| Self-reported function and disability | Late-Life Function and Disability Instrument (LLFDI) | Change; baseline, 6 months, 12 months | 
| Static balance (a) | 8 Level Balance Scale | Change; baseline, 6 months, 12 months | 
| Static balance (b) | Instrumented Tandem Stance | Change; baseline, 6 months, 12 months | 
| Gait speed | instrumented walking test (4m and 7m walk at usual and fast pace) | Change; baseline, 6 months, 12 months | 
| Functional leg strength (a) | Instrumented 30 second Chair Stand | Change; baseline, 6 months, 12 months | 
| Functional leg strength (b) | Instrumented Timed Up-and-Go | Change; baseline, 6 months, 12 months | 
| Handgrip strength | JAMAR dynamometer | Change; baseline, 6 months, 12 months | 
| Cognitive status | Montreal Cognitive Assessment Tool (MoCA) | Change; baseline, 6 months, 12 months | 
| Balance confidence | Activities-specific Balance Confidence Scale (ABC-Scale) | Change; baseline, 6 months, 12 months | 
| Fear of falling | Short Falls Efficacy Scale-International (Short FES-I) | Change; baseline, 6 months, 12 months | 
| Health status (a) | EQ-5D-5L | Change; baseline, 6 months, 12 months | 
| Health status (b) | EQ-VAS | Change; baseline, 6 months, 12 months | 
| Health-related resource use | questionnaire for the use of medical and non-medical services in old age (FIMA) | Change; baseline, 6 months, 12 months | 
| Depressive Symptoms | 10 Item Center for Epidemiological Studies - Depression (CES-D-10) | Change; baseline, 6 months, 12 months | 
| Subjective age | Subjectively felt age in years | Change; baseline, 6 months, 12 months | 
| Habit strength | Self-Report Behavioural Automaticity Index (SRBAI) | Change; baseline, 6 months, 12 months | 
| Motivational quality | Behavioural Regulation in Exercise Questionnaire (BRE-Q-3) | Change; baseline, 12 months | 
| Health Action Process Approach (HAPA) - Int | Intention (2 items, 6-point Likert scale) | Change; baseline, 6 months, 12 months | 
| Health Action Process Approach (HAPA) - SE | Self-efficacy (6 items, 6-point Likert scale) | Change; baseline, 6 months, 12 months | 
| Health Action Process Approach (HAPA) - ACP | Action and coping planning (6 items, 6-point Likert scale) | Change; baseline, 6 months, 12 months | 
| Health Action Process Approach (HAPA) - IAC | Individual action control (3 items, 6-point Likert scale) | Change; baseline, 6 months, 12 months | 
| Social support | Loneliness Scale | Change; baseline, 6 months, 12 months | 
| Group cohesion | Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German) | Change; baseline, 6 months, 12 months | 
| Evaluation of the LiFE program | 10 questions regarding quality and acceptance of as well as satisfaction with the program (6-point Likert scale) | Change; after the last intervention session, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health promotion, Behaviour change, Physical activity, Fall prevention