Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: internet-based Lifestyle-integrated Functional Exercise (iLiFE), upper limb exercise training.
- Who it may be relevant to
- Registry conditions: Fall. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
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).
Interventions
- Behavioral internet-based Lifestyle-integrated Functional Exercise (iLiFE)
receiving internet-based LiFE training and home safety assessment - Behavioral upper limb exercise training
upper limb exercise training
Primary outcome measures
- fall incidence as assessed by monthly telephone or internet follow-up [Time frame: 12 months]
Secondary outcome measures (12)
- physiological fall risk as assessed by the Physiological Profile Assessment (PPA) [Time frame: 4 months]
- balance as assessed by the 4-stage stance [Time frame: 4 months]
- balance as assessed by functional reach tests [Time frame: 4 months]
- mobility as assessed by the Short Physical Performance Battery Test [Time frame: 4 months]
- mobility as assessed by the Timed Up and Go Test [Time frame: 4 months]
- mobility as assessed by the Ten Metre Walk Test [Time frame: 4 months]
- muscle mass as assessed by the Bioimpedance Analysis (BIA) [Time frame: 4 months]
- postural hypotension as assessed by the blood pressure in sitting and standing [Time frame: 4 months]
- physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK) [Time frame: 4 months]
- Cognitive flexibility as assessed by Trail Making Test [Time frame: 4 months]
- balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale [Time frame: 12 months]
- exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control — Hong Kong
Identifiers
NCT: NCT05694494 · 2020.622-T