FallNCT03599934
Effect of Home Exercise on Reducing Falls
A study testing Lifestyle integrated functional exercise program and Home safety assessment in people with Fall, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fall
- What is being tested?
- Lifestyle integrated functional exercise program and Home safety assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesHong Kong
- Study dates
- 18 Jul 2018to 2 Oct 2021
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 or older
- able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
- able to walk for ≥ 10 meters
- history of falls in the past 12 months
- living in the community
- without MCI or dementia according to the 5-minute Montreal Cognitive assessment
- have a moderate fall risk or above as assessed by the Physiological Profile Assessment
- able to understand Chinese.
Who cannot join
- blindness
- diagnosis of mental disorders (e.g., severe depression, schizophrenia)
- any contraindications to exercise (e.g. unstable angina).
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Chinese University of Hong Kong Jockey Club Centre of Osteoporosis Care and Control
Hong Kong
The Chinese University of Hong Kong
Hong Kong
About this study
Official title: The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial
This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.
Read the detailed description
This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.
- Conditions
- Fall
- Being tested
- Lifestyle integrated functional exercise program, Home safety assessment
- Keywords
- Elderly, Exercise, Fall, Home safety
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle integrated functional exercise programOther
Lifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months.
Home safety assessmentOther
Home safety assessment and modification that targets to reduce environmental risk factors of falls.
| Study group | Role | What they receive |
|---|---|---|
| LiFE training and home safety assessment | Experimental | The participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment Receives: Other: Lifestyle integrated functional exercise program; Other: Home safety assessment |
| Control group | No intervention | The control group will continue their usual daily routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall
Prospective fall data will be collected through telephone follow-up for 1.5 year
Measured: 1.5 years
Secondary outcomes (9)
Handgrip strength
Hand grip strength will be assessed by handheld dynamometer
Measured: Baseline and follow-up assessment at 6-month
Functional lower body strength
Five-time sit-to-stand test will be used to assess lower body strength
Measured: Baseline and follow-up assessment at 6-month
Single leg standing balance
Single leg standing balance of both legs will be assessed
Measured: Baseline and follow-up assessment at 6-month
10-meter walk test
The usual walking speed on a 10-meter walkway
Measured: Baseline and follow-up assessment at 6-month
Timed-up and Go test
The time required to stand up from a chair, walk 3-m, return, and sit down, in comfortable speed
Measured: Baseline and follow-up assessment at 6-month
Timed-up and Go test with dual-task
The timed-up and Go test would be tested while asking the participants to do serial-3-subtraction
Measured: Baseline and follow-up assessment at 6-month
Montreal Cognitive Assessment 5-minute protocol
A standardized cognitive test
Measured: Baseline and follow-up assessment at 6-month
Activity level
Selected participants will be asked to wear an activity tracker for 7 days to examine their activity level
Measured: Baseline and follow-up assessment at 6-month
Fall risk
Physiological Profile Assessment (PPA) will be used to assess fall risk
Measured: Baseline and follow-up assessment at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start18 Jul 2018
- Primary completion10 Nov 2020
- Study completion2 Oct 2021
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
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, MD, Principal investigator, The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599934
- Sponsor's protocol ID
- 2017.400
- Status last verified
- Nov 2021
- First submitted
- 16 Jul 2018
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lifestyle-integrated Functional Exercise Plus a Home Safety Visit on Reducing Falls in Community Older Fallers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03599934
- Acronym / sponsor ID
- 2017.400
- Conditions
- Fall
- Keywords
- Elderly, Exercise, Fall, Home safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 26 Jul 2018 (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.
This proposed randomized controlled trial aims to study the long-term compliance of the LiFE program and its combined effects with a home safety visit on fall prevention in community-dwelling older fallers.
Detailed description
This will be a single-blinded randomized controlled trial. The subjects will be randomly assigned to the LiFE exercise plus home safety assessment group, or the control group by a computer program operated by an independent researcher. This study conforms to the ethical principles of the World Medical Association Declaration of Helsinki.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiFE training and home safety assessment | Experimental | Other: Lifestyle integrated functional exercise program, Other: Home safety assessmentThe participants will receive Lifestyle Integrated Functional Exercise Program and Home safety assessment |
| Control group | No intervention | –The control group will continue their usual daily routine. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged 60 or older
- able to ambulate with a Functional Ambulation Category (FAC) score ≥ 3
- able to walk for ≥ 10 meters
- history of falls in the past 12 months
- living in the community
Key exclusion criteria (3 listed)
- blindness
- diagnosis of mental disorders (e.g., severe depression, schizophrenia)
- any contraindications to exercise (e.g. unstable angina).
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 |
|---|---|---|
| Lifestyle integrated functional exercise programLifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months. | Other | LiFE training and home safety assessment |
| Home safety assessmentHome safety assessment and modification that targets to reduce environmental risk factors of falls. | Other | LiFE training and home safety assessment |
Primary outcome
Fall
Time frame: 1.5 years
Prospective fall data will be collected through telephone follow-up for 1.5 year
9 secondary outcomes
Handgrip strength
Time frame: Baseline and follow-up assessment at 6-month
Functional lower body strength
Time frame: Baseline and follow-up assessment at 6-month
Single leg standing balance
Time frame: Baseline and follow-up assessment at 6-month
10-meter walk test
Time frame: Baseline and follow-up assessment at 6-month
Timed-up and Go test
Time frame: Baseline and follow-up assessment at 6-month
Timed-up and Go test with dual-task
Time frame: Baseline and follow-up assessment at 6-month
Montreal Cognitive Assessment 5-minute protocol
Time frame: Baseline and follow-up assessment at 6-month
Activity level
Time frame: Baseline and follow-up assessment at 6-month
Fall risk
Time frame: Baseline and follow-up assessment at 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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, MD principal investigator
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle integrated functional exercise program and Home safety assessment in people with Fall, run by Chinese University of Hong Kong at 2 sites 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 8 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: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 1.5 years). 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 18 Nov 2021.