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

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.

• Lifestyle-integrated Functional Exercise (Behavioral): 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 training (Behavioral): Upper limb mobilisation and flexibility training, including arm circles, deltoid stretches, shoulder internal rotations, etc.

Primary outcomes

• Generic Balance ability [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.

Secondary outcomes

• Number of real-life falls [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).
• Dynamic balance [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).
• Balance confidence [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.
• Functional lower body strength [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).
• Number of laboratory falls [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.
• Depressive symptoms [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.
• Health-related quality of life [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.
• Muscle activations [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.
• Physical activity [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.
• Cognitive flexibility and executive function [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).
• Perceived ability to execute reactive stepping [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.
• Exercise adherence [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.

Sex: All, ages: 60 Years to any

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

• Charlotte Sau Lan Tsang, PhD, Principal investigator, The Hong Kong Polytechnic University