FallNCT05694494
Training- and Cost-effectiveness of an Internet-based Lifestyle-integrated Functional Exercise Program (iLiFE)
A study testing internet-based Lifestyle-integrated Functional Exercise (iLiFE) and upper limb exercise training in people with Fall, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- internet-based Lifestyle-integrated Functional Exercise (iLiFE) and upper limb exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 May 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Hong Kong
About this study
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
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.
Read the 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).
- Conditions
- Fall
- Being tested
- internet-based Lifestyle-integrated Functional Exercise (iLiFE), upper limb exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based Lifestyle-integrated Functional Exercise (iLiFE)Behavioural
receiving internet-based LiFE training and home safety assessment
upper limb exercise trainingBehavioural
upper limb exercise training
| Study group | Role | What they receive |
|---|---|---|
| iLiFE | Experimental | receiving Lifestyle-integrated Functional Exercise training and home safety assessment Receives: Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE) |
| attention control | Placebo comparator | upper limb exercise training Receives: Behavioral: upper limb exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
fall incidence as assessed by monthly telephone or internet follow-up
Measured: 12 months
Secondary outcomes (13)
physiological fall risk as assessed by the Physiological Profile Assessment (PPA)
will be done at the baseline- and re-assessments
Measured: 4 months
balance as assessed by the 4-stage stance
will be done at the baseline- and re-assessments
Measured: 4 months
balance as assessed by functional reach tests
will be done at the baseline- and re-assessments
Measured: 4 months
mobility as assessed by the Short Physical Performance Battery Test
will be done at the baseline- and re-assessments
Measured: 4 months
mobility as assessed by the Timed Up and Go Test
will be done at the baseline- and re-assessments
Measured: 4 months
mobility as assessed by the Ten Metre Walk Test
will be done at the baseline- and re-assessments
Measured: 4 months
muscle mass as assessed by the Bioimpedance Analysis (BIA)
will be done at the baseline- and re-assessments
Measured: 4 months
postural hypotension as assessed by the blood pressure in sitting and standing
will be done at the baseline- and re-assessments
Measured: 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.
Measured: 4 months
Cognitive flexibility as assessed by Trail Making Test
will be done at the baseline- and re-assessments
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start2 May 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy Kwok, Principal investigator, The Chinese Univsersity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694494
- Sponsor's protocol ID
- 2020.622-T
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05694494
- Acronym / sponsor ID
- 2020.622-T
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLiFE | Experimental | Behavioral: internet-based Lifestyle-integrated Functional Exercise (iLiFE)receiving Lifestyle-integrated Functional Exercise training and home safety assessment |
| attention control | Placebo comparator | Behavioral: upper limb exercise trainingupper limb exercise training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based Lifestyle-integrated Functional Exercise (iLiFE)receiving internet-based LiFE training and home safety assessment | Behavioural | iLiFE |
| upper limb exercise trainingupper limb exercise training | Behavioural | attention control |
Primary outcome
fall incidence as assessed by monthly telephone or internet follow-up
Time frame: 12 months
13 secondary outcomes
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
health-related quality of life as assessed by EQ-5D-5L
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Fall
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Kwok principal investigator
The Chinese Univsersity of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based Lifestyle-integrated Functional Exercise (iLiFE) and upper limb exercise training in people with Fall, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fall incidence as assessed by monthly telephone or internet follow-up (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.