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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Generic Balance ability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
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.
干预措施: Lifestyle-integrated Functional Exercise (Behavioral)
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.
干预措施: Upper limb mobilisation and flexibility training (Behavioral)
结局指标
主要结局
Generic Balance ability
时间窗: 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.
次要结局
- Number of real-life falls([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([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Balance confidence([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Functional lower body strength([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Number of laboratory falls([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Depressive symptoms([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Health-related quality of life([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Muscle activations([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Physical activity([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Cognitive flexibility and executive function([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Perceived ability to execute reactive stepping([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
- Exercise adherence([Time Frame: Week 0, baseline assessment; Week 10, post-intervention assessment; Week 22, follow-up assessment.])
研究者
TSANG Sau Lan Charlotte
Assistant Professor
The Hong Kong Polytechnic University