Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)

Study Overview
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Brief Summary
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Falls are the second leading cause of unintentional injury and death around the globe. About one in every three older adults falls each year worldwide. With the aging population, the cost of treating fall-related injuries is increasing exponentially. There is a pressing need for a cost-effective fall prevention program. Ample evidence has shown the substantial standalone effectiveness of well-designed physical exercises in preventing falls. However, continuous exercise adherence is required for a long-lasting fall prevention effect. Unfortunately, adherence to an exercise program was generally only 21%. Building up the habit of doing regular exercise is thus crucial in preventing falls. Lifestyle integrated Functional Exercise program (LiFE) has been shown to be able to reduce the fall rate by 31% and maintain 64% of the participants exercising at 12 months follow-up. This proposed randomized controlled trial aims at comparing the effectiveness of an internet-based LiFE in reducing subsequent falls and promoting exercise adherence in community-dwelling older adults.

Detailed Description
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All subjects will then be randomly assigned to receive either an internet-based therapist-led LiFE program with a home environment safety assessment (iLiFE) or attention control intervention. Randomization into block groups of four in a 1:1 ratio (the iLiFE group or the attention control group) will be generated in a password-protected excel file by independent research personnel not involved in data collection or intervention after the baseline assessment. The randomization will be concealed by the independent personnel. Research assistants who are blinded to the group allocation will conduct all the subsequent monthly surveillance and assessments at baseline and follow-up sessions. All data will also be entered and checked by the blinded research assistants. All procedures concur with the Declaration of Helsinki (2013).

Official Title
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Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE) on Reducing Falls, and Promoting Exercise Adherence in Community Older Fallers: a Randomized Controlled Trial

Conditions
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Fall

Intervention / Treatment
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* Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)
* Behavioral: upper limb exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged ≥ 65 years, community-dwelling, have a fall history in the previous 12 months, have a moderate or above risk of falls as assessed by the Physiological Profile Assessment (total z-score ≥ 1) can ambulate on level surfaces without physical contact of another person as assessed by Functional Ambulation Category (score ≥ 3) cognitively intact as assessed by the Hong Kong version of the Montreal Cognitive Assessment-5-minute protocol (score ≥ 16th percentile of the age and education-adjusted cut-off score) able to communicate effectively. Exclusion Criteria: uncorrected vision or hearing impairment, unstable medical condition that may preclude the planned exercises, and have been receiving or planning to receive any fall prevention program within the study period.

Ages Eligible for Study
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Minimum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iLiFE<br>receiving Lifestyle-integrated Functional Exercise training and home safety assessment | Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)<br>* receiving internet-based LiFE training and home safety assessment<br>|
| Placebo Comparator: attention control<br>upper limb exercise training | Behavioral: upper limb exercise training<br>* upper limb exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fall incidence as assessed by monthly telephone or internet follow-up |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological fall risk as assessed by the Physiological Profile Assessment (PPA) | will be done at the baseline- and re-assessments | 4 months | 
| balance as assessed by the 4-stage stance | will be done at the baseline- and re-assessments | 4 months | 
| balance as assessed by functional reach tests | will be done at the baseline- and re-assessments | 4 months | 
| mobility as assessed by the Short Physical Performance Battery Test | will be done at the baseline- and re-assessments | 4 months | 
| mobility as assessed by the Timed Up and Go Test | will be done at the baseline- and re-assessments | 4 months | 
| mobility as assessed by the Ten Metre Walk Test | will be done at the baseline- and re-assessments | 4 months | 
| muscle mass as assessed by the Bioimpedance Analysis (BIA) | will be done at the baseline- and re-assessments | 4 months | 
| postural hypotension as assessed by the blood pressure in sitting and standing | will be done at the baseline- and re-assessments | 4 months | 
| physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK) | The participants will be required to wear the device for 7 consecutive days right after the baseline assessment and the re-assessment. Data about the duration of time spent in different activity types such as walking and sitting will be extracted and calculated on a daily basis. | 4 months | 
| Cognitive flexibility as assessed by Trail Making Test | will be done at the baseline- and re-assessments | 4 months | 
| balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale | will be done at the baseline assessment, re-assessment, and the last monthly telephone or internet follow-up. The participants will be asked to indicate their level of confidence in performing each activity on a 0-100 scale. A higher score indicates better balance confidence. | 12 months | 
| exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale | This will be done at the re-assessment and the last monthly telephone or internet follow-up. The total score ranges from 0 to 24. Higher total scores indicate better exercise adherence. | 12 months | 
| health-related quality of life as assessed by EQ-5D-5L | will be done at the baseline and re-assessment and the last monthly telephone or internet follow-up | 12 months |