Fall Prevention in Healthy AgingLiFE-SePBTNCT07842094
Effect of LiFE-SePBT on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial
A study testing Lifestyle-integrated Functional Exercise and Upper limb mobilisation and flexibility training in people with Fall Prevention in Healthy Aging and Fall, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study is an assessor-blinded randomised controlled trial investigating the effects of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) on postural stability in community-dwelling older adults with an elevated risk of falling. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fall Prevention in Healthy Aging, Fall, Fall Prevention Training
- What is being tested?
- Lifestyle-integrated Functional Exercise and Upper limb mobilisation and flexibility training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Jun 2026to 17 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Community-dwelling older adults aged 60 or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- A score of ≥ 6 in the Abbreviated Mental Test (Hong Kong)
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing
Who cannot join
- Uncorrected vision or hearing impairment
- Osteoporosis
- Hip or knee replacement within the last year
- Resting blood pressure ≥ 160/100 mmHg even with medication taken
- A score of ≤ 6 in 5-items Geriatric Depression Scale (GDS-5)
- Have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Kowloon, 000
Bryan Tsz Lok Heung, Bsc, +852-9210-2491, 26119566r@connect.polyu.hk
About this study
Official title: Combined Effects of Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial
This study is an assessor-blinded randomised controlled trial investigating the effects of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) on postural stability in community-dwelling older adults with an elevated risk of falling.
Read the detailed description
Participants will be randomly assigned to two groups: LiFE-SePBT or an attention control group. All participants will provide their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. After baseline assessment, both groups will receive five 90-minute intervention sessions over 10 weeks. Between-group differences in behaviour will be examined before and after training to identify immediate training-induced changes in postural stability. Retention of the changes in postural stability will be assessed four months after the training period. Fall incidents will be followed up for 12 months after training.
- Conditions
- Fall Prevention in Healthy Aging, Fall, Fall Prevention Training, Postural Control, Postural Instability, Balance Control in Elderly
- Being tested
- Lifestyle-integrated Functional Exercise, Upper limb mobilisation and flexibility training
- Keywords
- Lifestyle-integrated Functional Exercise, Reactive balance, Dynamic balance, Fall prevention, Self-initiated Perturbation-based Balance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle-integrated Functional ExerciseBehavioural
Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Exercise (LiFE-SePBT) is a synergistic fall prevention programme. LiFE programme targets generic balance and muscle strength whereas SePBT mainly influences through reactive balance.
Upper limb mobilisation and flexibility trainingBehavioural
Upper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc.
| Study group | Role | What they receive |
|---|---|---|
| LiFE-SePBT | Experimental | 5 sessions of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) will be delivered. The LiFE component involves having participants embed functional exercises into their lifestyle, as well as practising recovering their balance upon self-initiated perturbation. Each session is 90 minutes long and will be hosted once every 2 weeks. Receives: Behavioral: Lifestyle-integrated Functional Exercise |
| Attention control group | Placebo comparator | Participants in the attention control group will receive 5 sessions of upper limb mobilisation and flexibility exercises. Each session is 90 minutes long and will be held once every 2 weeks. Receives: Behavioral: Upper limb mobilisation and flexibility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic Balance ability
Generic balance ability will be assessed by the Mini-BESTest. Mini-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for a comprehensive examination of improvements that occur in reactive control.
Measured: Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)
Secondary outcomes (12)
Number of real-life falls
The number of real-life falls in months after randomization will be recorded. Fall circumstances and related injuries will be required via phone contact. A fall is defined as an event resulting in a person unintentionally coming to rest on the ground or other lower level, not as the result of a major intrinsic event (e.g., syncope, stroke, or overwhelming hazard such as an earthquake).
Measured: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
Dynamic balance
Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds).
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Balance confidence
Balance confidence will be measured with the Chinese version of the shortened version of Activities-specific Balance Confidence Scale (ABC-6). The scale value is from 0 to 100, with higher values representing higher balance confidence.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Functional lower body strength
Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds).
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Number of laboratory falls
Participants will be exposed to one trip-like perturbation and slip-like perturbation on each foot at an unexpected time. The number of falls upon perturbations will be recorded.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Depressive symptoms
Depressive symptoms will be assessed by Five-Item Geriatric Depression Scale. Participants will be asked to answer 5 questions as yes or no. The answer "no" for the first question and "yes" for the other four questions will be evaluated for depression.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Health-related quality of life
Health-related quality of life will be assessed by the EQ-5D-5L. In the EQ-5D-5L descriptive system, each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Each health state is identified by a five-digit code, with 11111 representing the best and 55555 the worst possible health state.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Muscle activations
Muscle activations will be assessed by surface electromyography using an electromyography system (Trigno IM, Delsys Inc., Natick, MA, USA). Fourteen electrodes are placed bilaterally over erector spinae, rectus abdominis, gastrocnemius medialis, biceps femoris, rectus femoris, tibialis anterior, and gluteus medius according to the SENIAM guidelines (www.seniam.org) by the physical therapist.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Physical activity
Physical activity will be assessed by the Physical Activity Scale for the Elderly. This questionnaire will ask participants to recall their activity over the last 7-days. Activity types include sitting, walking, sport/recreation, exercise, occupational and household. A total score for physical activity can be calculated using these answers and the predetermined weights associated with each activity.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Cognitive flexibility and executive function
Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds).
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Perceived ability to execute reactive stepping
The perceived ability to execute reactive stepping in different scenarios in real life situations via Short-Form Balance Recovery Confidence (SF-BRC) Scale. Each item is ranked from 0-10.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Exercise adherence
Exercise adherence will be measured via the Chinese version of Exercise Adherence Rating Scale (EARS-C). The total score of this scale is ranked between 0 to 24; each item is graded from 0 to 4 while item 1, 4 and 6 are reverse-scored.
Measured: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start12 Jun 2026
- Primary completion17 Dec 2028 (estimated)
- Study completion17 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Prevention in Healthy AgingStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Sau Lan Charlotte, The Hong Kong Polytechnic University
- Investigators
- Charlotte Sau Lan Tsang, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842094
- Sponsor's protocol ID
- HSEARS20260330008
- Acronym
- LiFE-SePBT
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to participant privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07842094
- Acronym / sponsor ID
- LiFE-SePBT / HSEARS20260330008
- Conditions
- Fall Prevention in Healthy Aging, Fall, Fall Prevention Training, Postural Control, Postural Instability, Balance Control in Elderly
- Keywords
- Lifestyle-integrated Functional Exercise, Reactive balance, Dynamic balance, Fall prevention, Self-initiated Perturbation-based Balance Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 17 Dec 2028 (estimated)
- Study completion
- 17 Dec 2029 (estimated)
- First posted
- 25 Sep 2026 (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 study is an assessor-blinded randomised controlled trial investigating the effects of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) on postural stability in community-dwelling older adults with an elevated risk of falling.
Detailed description
Participants will be randomly assigned to two groups: LiFE-SePBT or an attention control group. All participants will provide their written informed consent before baseline assessment. The study will be reported and conducted in line with the CONSORT statement. Participants will be recruited via convenience sampling in the local community. After baseline assessment, both groups will receive five 90-minute intervention sessions over 10 weeks. Between-group differences in behaviour will be examined before and after training to identify immediate training-induced changes in postural stability. Retention of the changes in postural stability will be assessed four months after the training period. Fall incidents will be followed up for 12 months after training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiFE-SePBT | Experimental | Behavioral: Lifestyle-integrated Functional Exercise5 sessions of combined Lifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Training (LiFE-SePBT) will be delivered. The LiFE component involves having participants embed functional exercises into their lifestyle, as well as practising recovering their balance upon self-initiated perturbation. Each session is 90 minutes long and will be hosted once every 2 weeks. |
| Attention control group | Placebo comparator | Behavioral: Upper limb mobilisation and flexibility trainingParticipants in the attention control group will receive 5 sessions of upper limb mobilisation and flexibility exercises. Each session is 90 minutes long and will be held once every 2 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling older adults aged 60 or older
- Able to communicate effectively in Cantonese or Mandarin
- Able to walk independently on level ground for at least 30 minutes
- A score of ≥ 6 in the Abbreviated Mental Test (Hong Kong)
- Have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing
Key exclusion criteria (6 listed)
- Uncorrected vision or hearing impairment
- Osteoporosis
- Hip or knee replacement within the last year
- Resting blood pressure ≥ 160/100 mmHg even with medication taken
- A score of ≤ 6 in 5-items Geriatric Depression Scale (GDS-5)
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 ExerciseLifestyle-integrated Functional Exercise and Self-initiated Perturbation-based Balance Exercise (LiFE-SePBT) is a synergistic fall prevention programme. LiFE programme targets generic balance and muscle strength whereas SePBT mainly influences through reactive balance. | Behavioural | LiFE-SePBT |
| Upper limb mobilisation and flexibility trainingUpper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc. | Behavioural | Attention control group |
Primary outcome
Generic Balance ability
Time frame: Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)
Generic balance ability will be assessed by the Mini-BESTest. Mini-BESTest can challenge balance across anticipatory postural adjustments, postural responses, sensory orientation and stability in gait, allowing for a comprehensive examination of improvements that occur in reactive control.
12 secondary outcomes
Number of real-life falls
Time frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months after the intervention.
Dynamic balance
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Balance confidence
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Functional lower body strength
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Number of laboratory falls
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Depressive symptoms
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Health-related quality of life
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Muscle activations
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Physical activity
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Cognitive flexibility and executive function
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Perceived ability to execute reactive stepping
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Exercise adherence
Time frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Due to participant privacy concerns.
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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.
Charlotte Sau Lan Tsang, PhD principal investigator
The Hong Kong Polytechnic University
1 site 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 and Upper limb mobilisation and flexibility training in people with Fall Prevention in Healthy Aging and Fall, run by The Hong Kong Polytechnic University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Tsz Lok Heung, Bsc (+852-9210-2491, 26119566r@connect.poly.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generic Balance ability (time frame: Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)). 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 1 Oct 2026.