Effect of LiFE-SePBT on Postural Stability in Community-dwelling Older Adults: an Assessor-blinded Randomised Controlled Trial (LiFE-SePBT)

September 28, 2026 updated by: TSANG Sau Lan Charlotte, The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
    • Kowloon
      • Hung Hom, Kowloon, Hong Kong, 000
        • Recruiting
        • The Hong Kong Polytechnic University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: LiFE-SePBT

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.
Behavioral: Lifestyle-integrated Functional Exercise

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.
Placebo Comparator: Attention control group

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.
Behavioral: Upper limb mobilisation and flexibility training

Upper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

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).
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.

Dynamic balance will be assessed by Alternative Step Test (in the unit of seconds).
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.

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.
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.

Functional lower body strength will be assessed by Five-time Sit to Stand Test (in the unit of seconds).
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.

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.
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.

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.
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.

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.
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.

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.
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.

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.
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.

Cognitive flexibility and executive function will be assessed by Trial Making Tests A and B (in the unit of seconds).
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.

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.
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.

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.
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charlotte Sau Lan Tsang, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSEARS20260330008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to participant privacy concerns.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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