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

Exercise Clinical Trial

— LiFE-is-LiFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462654
• Other study ID #: 01GL1705A-D
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: September 30, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Fall Prevention

Intervention

Behavioral:
• iLiFE
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
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.

Locations

Country	Name	City	State
Germany	Heidelberg University, Network Aging Research	Heidelberg
Germany	Robert Bosch Hospital, Klinik für Geriatrische Rehabilitation	Stuttgart

Sponsors (5)

Lead Sponsor	Collaborator
Heidelberg University	German Federal Ministry of Education and Research, Robert Bosch Gesellschaft für Medizinische Forschung mbH, Universitätsklinikum Hamburg-Eppendorf, University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cost-effectiveness of iLiFE and gLiFE	Incremental Cost-Effectiveness Ratios (ICERs) of delivering iLiFE and gLiFE	Change; baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-reported function and disability	Late-Life Function and Disability Instrument (LLFDI)	Change; baseline, 6 months, 12 months
Secondary	Static balance (a)	8 Level Balance Scale	Change; baseline, 6 months, 12 months
Secondary	Static balance (b)	Instrumented Tandem Stance	Change; baseline, 6 months, 12 months
Secondary	Gait speed	instrumented walking test (4m and 7m walk at usual and fast pace)	Change; baseline, 6 months, 12 months
Secondary	Functional leg strength (a)	Instrumented 30 second Chair Stand	Change; baseline, 6 months, 12 months
Secondary	Functional leg strength (b)	Instrumented Timed Up-and-Go	Change; baseline, 6 months, 12 months
Secondary	Handgrip strength	JAMAR dynamometer	Change; baseline, 6 months, 12 months
Secondary	Cognitive status	Montreal Cognitive Assessment Tool (MoCA)	Change; baseline, 6 months, 12 months
Secondary	Balance confidence	Activities-specific Balance Confidence Scale (ABC-Scale)	Change; baseline, 6 months, 12 months
Secondary	Fear of falling	Short Falls Efficacy Scale-International (Short FES-I)	Change; baseline, 6 months, 12 months
Secondary	Health status (a)	EQ-5D-5L	Change; baseline, 6 months, 12 months
Secondary	Health status (b)	EQ-VAS	Change; baseline, 6 months, 12 months
Secondary	Health-related resource use	questionnaire for the use of medical and non-medical services in old age (FIMA)	Change; baseline, 6 months, 12 months
Secondary	Depressive Symptoms	10 Item Center for Epidemiological Studies - Depression (CES-D-10)	Change; baseline, 6 months, 12 months
Secondary	Subjective age	Subjectively felt age in years	Change; baseline, 6 months, 12 months
Secondary	Habit strength	Self-Report Behavioural Automaticity Index (SRBAI)	Change; baseline, 6 months, 12 months
Secondary	Motivational quality	Behavioural Regulation in Exercise Questionnaire (BRE-Q-3)	Change; baseline, 12 months
Secondary	Health Action Process Approach (HAPA) - Int	Intention (2 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Secondary	Health Action Process Approach (HAPA) - SE	Self-efficacy (6 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Secondary	Health Action Process Approach (HAPA) - ACP	Action and coping planning (6 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Secondary	Health Action Process Approach (HAPA) - IAC	Individual action control (3 items, 6-point Likert scale)	Change; baseline, 6 months, 12 months
Secondary	Social support	Loneliness Scale	Change; baseline, 6 months, 12 months
Secondary	Group cohesion	Kohäsion im Team von Freizeit- und Gesundheitssportgruppen Scale (German)	Change; baseline, 6 months, 12 months
Secondary	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

External Links

•   Project homepage