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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorThe Hong Kong Polytechnic University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Uncorrected vision or hearing impairment

Osteoporosis

Hip or knee replacement within the last year

Resting blood pressure ≥ 160/100 mmHg even with medication taken

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: LiFE-SePBTExperimental treatment 1 intervention
Group B: Attention control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
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.
2

Dynamic balance

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

Time frame
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
3

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.

Time frame
Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
4

Functional lower body strength

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

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

Other outcomes

Sponsors and contacts

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