Pilot of a Group-based Program on Lifestyle-integrated Functional Exercise (LiFE) in Older Persons

Study Overview
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Brief Summary
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This feasibility pilot is part of the project LiFE-is-LiFE (2017-2020). It is based on the Lifestyle-Integrated Functional Exercise (LiFE) program by Clemson et al., which has proven effective in improving strength, balance, and physical activity while simultaneously reducing falls in older people via incorporating exercises in recurring daily tasks. However, implementing the original LiFE program includes high financial requirements and human resources. Therefore, LiFE-is-LiFE investigates whether implementing LiFE in groups (gLiFE) is not inferior to the original, individually delivered LiFE in terms of reducing falls per physical activity. In this pilot study, we evaluate our conception of gLiFE for large-scale use in the subsequent, larger LiFE-is-LiFE trial.

Official Title
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Feasibility of the Lifestyle-integrated Functional Exercise Concept Delivered in a Group (gLiFE) of Persons Above 70 Years of Age - a Pilot Study

Conditions
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Fall Prevention, Physical Activity

Intervention / Treatment
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* Behavioral: group lifestyle-integrated functional exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling Aged 70+ Exclusion Criteria: Cognitive impairment Neurological condition which severely influences gait and mobility Severe visual impairment Inability to ambulate independently Significant lung disease or chronic heart failure or any other unstable or terminal illness that would preclude the planned exercises

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gLiFE pilot group<br> | Behavioral: group lifestyle-integrated functional exercise<br>* Manualized teaching of balance and strength principles and integration of exercises and physical activity into daily routine during 7 sessions in a group of 8 to 10 participants with 2 trainers. The pilot intervention group will undergo the same strength and balance exercises and learn about the same physical activity enhancement strategies as described in the LiFE programme by Clemson et al. (BMJ 2012;345:e4547). However, instead of 7 home visits, gLiFE participants will attend seven group sessions (1 session/week). In these, LiFE contents are adapted to the group setting and enhanced by health psychological and behaviour change strategies fitting to the social structure and modalities of a group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence of the participants to LiFE activities | Measured using the Exercise Adherence Rating Scale (EARS) | Change from the first of 7 intervention sessions (i.e., at week 1) at the end of the intervention period (i.e., week 7) | 
| Evaluation of the intervention and its components | Rating of helpfulness (5-point Likert scale), safety (5-point Likert scale), level of difficulty (5-point Likert scale), and adaptability (5-point Likert scale) | at the end of the intervention period (i.e., week 7) | 
| Participants' views on the gLiFE program | Participants' views on: planning and engaging in gLiFE activities the gLiFE manual support from the trainers their ideas for improving the program the group format | at the end of the intervention period (i.e., week 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance | Timed up-and-go test (measured in seconds; shorter time represents better performance) | Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7) | 
| Motor performance (balance) | 8 Level balance scale (measured in accomplished levels; higher level represents better performance) | Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7) | 
| Motor performance (strength) | 5-chair rise (measured in seconds; shorter time represents better performance) | Change from baseline (i.e., before the first session) at the end of the intervention period (i.e., week 7) |