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.
研究概览
地位
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Bryan Tsz Lok Heung, Bsc
- 电话号码:+852-9210-2491
- 邮箱:26119566r@connect.poly.hk
学习地点
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Kowloon
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Hung Hom、Kowloon、香港、000
- 招聘中
- The Hong Kong Polytechnic University
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接触:
- Bryan Tsz Lok Heung, Bsc
- 电话号码:+852-9210-2491
- 邮箱:26119566r@connect.polyu.hk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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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. |
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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 |
|---|---|---|
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Generic Balance ability
大体时间:Week 0 (baseline assessment), week 10 (post-assessment), week 22 (i.e., 3-month follow-up assessment)
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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)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
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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.
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Dynamic balance
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Balance confidence
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Functional lower body strength
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Number of laboratory falls
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Depressive symptoms
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Health-related quality of life
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Muscle activations
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Physical activity
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Cognitive flexibility and executive function
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Perceived ability to execute reactive stepping
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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Exercise adherence
大体时间:Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.
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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.
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合作者和调查者
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
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- HSEARS20260330008
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Due to participant privacy concerns.
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