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

N/ARecruitingNCT07842094

The Hong Kong Polytechnic University44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Fall Prevention in Healthy Aging Fall

Interventions

Lifestyle-integrated Functional ExerciseBEHAVIORAL

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 trainingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: (1) Community-dwelling older adults aged 60 years old or older; (2) able to communicate effectively in Cantonese or Mandarin; (3) able to walk independently on level ground for at least 30 minutes; (4) a score of ≥ 6 in the Abbreviated Mental Test (Hong Kong); and (5) have fallen in the preceding year, have concerns about falling, or feel unsteady while walking or standing. Exclusion Criteria: (1) Uncorrected vision or hearing impairment; (2) osteoporosis; (3) hip or knee replacement within the last year; (3) resting blood pressure ≥ 160/100 mmHg even with medication taken; (4) a score of ≤ 6 in 5-items Geriatric Depression Scale (GDS-5); and (5) have musculoskeletal, cardiovascular, mental, or neurological disorders that preclude their participation in the assessment or intervention safety.

Outcomes

Primary Outcomes

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.

Time frame: Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)

Secondary Outcomes

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).

Time frame: [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

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