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

Heidelberg University

Status: Completed

Conditions: Exercise; Fall Prevention

Treatments: Behavioral: gLiFE; Behavioral: iLiFE

Study type: Interventional

Funder types: Other

Identifiers

NCT03462654

01GL1705A-D

Details and patient eligibility

About

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).

Full 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).

Enrollment: 310 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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310 participants in 2 patient groups

individual LiFE (iLiFE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: iLiFE

group LiFE (gLiFE)

Experimental group

Description:

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.

Treatment:

Behavioral: gLiFE