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

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: Recruiting
• Conditions: Fall; Fall Prevention in Healthy Aging; Postural Control; Postural Instability; Balance Control in Elderly; Fall Prevention Training
• Intervention / Treatment: Behavioral: Lifestyle-integrated Functional Exercise; Behavioral: Upper limb mobilisation and flexibility training

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: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bryan Tsz Lok Heung, Bsc; Phone Number: +852-9210-2491; Email: 26119566r@connect.poly.hk

Study Locations

• Hong Kong
  • Kowloon
    • Hung Hom, Kowloon, Hong Kong, 000
      • Recruiting
      • The Hong Kong Polytechnic University
      • Contact: Bryan Tsz Lok Heung, Bsc; Phone Number: +852-9210-2491; Email: 26119566r@connect.polyu.hk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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).	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.	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.	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.	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.	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.	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).	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.	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.	Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Charlotte Sau Lan Tsang, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2026
• Primary Completion (Estimated): December 17, 2028
• Study Completion (Estimated): December 17, 2029

Study Registration Dates

• First Submitted: September 21, 2026
• First Submitted That Met QC Criteria: September 21, 2026
• First Posted (Actual): September 25, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 28, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Fall prevention; Reactive balance; Dynamic balance; Lifestyle-integrated Functional Exercise; Self-initiated Perturbation-based Balance Training
• Other Study ID 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