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

2026年9月28日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Kowloon
      • Hung Hom、Kowloon、香港、000
        • 招聘中
        • The Hong Kong Polytechnic University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

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.

安慰剂比较: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.

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Generic Balance ability
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Number of real-life falls
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Charlotte Sau Lan Tsang, PhD、The Hong Kong Polytechnic University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月12日

初级完成 (估计的)

2028年12月17日

研究完成 (估计的)

2029年12月17日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Due to participant privacy concerns.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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