Clinical trial NCT05694494: Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fall
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 322
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Primary outcomes:
measure: fall incidence as assessed by monthly telephone or internet follow-up
timeFrame: 12 months
Secondary outcomes:
measure: physiological fall risk as assessed by the Physiological Profile Assessment (PPA)
timeFrame: 4 months
measure: balance as assessed by the 4-stage stance
timeFrame: 4 months
measure: balance as assessed by functional reach tests
timeFrame: 4 months
measure: mobility as assessed by the Short Physical Performance Battery Test
timeFrame: 4 months
measure: mobility as assessed by the Timed Up and Go Test
timeFrame: 4 months
measure: mobility as assessed by the Ten Metre Walk Test
timeFrame: 4 months
measure: muscle mass as assessed by the Bioimpedance Analysis (BIA)
timeFrame: 4 months
measure: postural hypotension as assessed by the blood pressure in sitting and standing
timeFrame: 4 months
measure: physical activity level as assessed by thigh-worn accelerometer (ActivPAL4 physical activity monitor, PAL Technologies Ltd., Glasgow, UK)
timeFrame: 4 months
measure: Cognitive flexibility as assessed by Trail Making Test
timeFrame: 4 months
measure: balance confidence as assessed by the Short version of the Chinese version of the Activities-specific Balance Confidence Scale
timeFrame: 12 months
measure: exercise adherence as assessed by Section B of the Exercise Adherence Rating Scale
timeFrame: 12 months
measure: health-related quality of life as assessed by EQ-5D-5L
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Study officials:
affiliation: The Chinese Univsersity of Hong Kong
name: Timothy Kwok
role: PRINCIPAL_INVESTIGATOR
References: