Effects of Tai Chi on Balance Function in Community-Dwelling Older Adults: A Randomized Controlled Trial Examining the Predictive and Modifying Roles of Circadian Age, With Multi-Omics and Brain Function Assessments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change in Berg Balance Scale (BBS) Score
研究概览
简要总结
This study investigates the effects of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Participants are randomly assigned to either a Tai Chi exercise group or a health education control group. The primary outcome is balance function measured by the Berg Balance Scale. Secondary outcomes include physical function, psychological well-being, cognitive function, and sleep quality. The study also explores the predictive and modifying roles of baseline circadian age on intervention outcomes.
详细描述
BACKGROUND AND RATIONALE Falls are a leading cause of injury and disability in older adults, and balance dysfunction is a key modifiable risk factor. Tai Chi, a traditional Chinese mind-body exercise, has been shown to improve balance, reduce fall risk, and benefit cognitive health in older populations. However, individual variability in response to Tai Chi remains poorly understood, and the biological mechanisms underlying its benefits are incompletely characterized.
Circadian rhythm disruption has emerged as a hallmark of biological aging. The investigators have developed and validated a circadian age (CircAge) assessment system based on the UK Biobank cohort (N>90,000), which independently predicts mortality risk. Whether individuals with accelerated circadian aging benefit more from Tai Chi intervention is unknown. This trial addresses this gap by integrating circadian age assessment with multi-modal outcome evaluations.
OBJECTIVES The primary objective is to evaluate the effect of a 12-week Tai Chi intervention on balance function in community-dwelling older adults. Secondary objectives are to assess effects on physical function, psychological health, cognitive function, and sleep quality. Exploratory objectives are to examine the predictive and modifying roles of baseline circadian age acceleration on intervention outcomes.
STUDY DESIGN This is a two-arm parallel, single-blind (assessor-blinded) randomized controlled trial. Ninety community-dwelling older adults are randomly allocated 1:1 to a Tai Chi group or a health education control group. Randomization is computer-generated using variable block sizes, stratified by sex and baseline Berg Balance Scale score (≤45 vs >45). Allocation concealment is maintained via sequentially numbered opaque sealed envelopes. Outcome assessors are blinded to group allocation. After the 12-week intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
ASSESSMENT SCHEDULE Wrist-worn accelerometer (ActiGraph) recordings are collected at baseline over 7 consecutive days for circadian age computation. All baseline accelerometer recordings are completed prior to randomization. Full outcome assessments are conducted at baseline (week 0) and at the end of intervention (week 12). A streamlined midpoint assessment (week 6) includes only the Berg Balance Scale and Timed Up and Go test. Fasting blood samples for routine clinical chemistry are collected at week 0 and week 12.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to group allocation. Assessors are not involved in randomization or intervention delivery. Assessments are conducted in a separate location from the intervention sessions. All participants wear standardized clothing and footwear during assessment to prevent inadvertent unblinding. Participants are reminded not to disclose their group assignment to assessors.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 55 years or older
- •Community-dwelling
- •Able to walk independently (assistive devices such as canes are permitted)
- •Berg Balance Scale (BBS) score ≤52 at screening
- •Able to understand and follow verbal instructions
- •Willing to wear a wrist accelerometer continuously for 7 days at baseline
- •Willing to accept random group assignment
- •Willing to undergo blood collection during the study
- •Provides written informed consent
排除标准
- •Regular Tai Chi or yoga practice (more than once per week) within the past 6 months
- •Severe cognitive impairment (Montreal Cognitive Assessment [MoCA] score <20 at screening, or previously diagnosed dementia)
- •Unstable cardiovascular disease (myocardial infarction, stroke, or hospitalization within the past 3 months)
- •Severe musculoskeletal disease that limits exercise participation
- •Neurological diseases affecting balance (e.g., Parkinson's disease, severe peripheral neuropathy)
- •Currently participating in another exercise intervention study
- •Planned surgery or extended absence during the study period
- •Contraindications to functional near-infrared spectroscopy (fNIRS) examination (e.g., scalp injury, metallic implants in the head region)
- •Severe psychiatric illness (e.g., schizophrenia, bipolar disorder)
- •Considered unable to safely participate in moderate-intensity physical activity as judged by the study physician or attending healthcare provider
研究组 & 干预措施
Tai Chi Group
Participants in this group receive instruction in Yang-style 24-form Tai Chi from a nationally certified master coach. Tai Chi classes are offered five days per week, and participants are required to attend at least three sessions per week. Each session lasts 60 minutes, including warm-up, Tai Chi practice, cool-down, and Q&A. The intervention duration is 12 weeks. Class size is limited to 10-15 participants to ensure individualized guidance.
干预措施: Tai Chi Exercise (Behavioral)
Health Education Control Group
Participants in this group attend health education seminars led by professional medical and health management staff. Seminar topics include nutrition, chronic disease management, fall prevention, and safe medication use. The intervention duration is 12 weeks. After the intervention ends, this group is offered free Tai Chi classes to ensure ethical equipoise.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Change in Berg Balance Scale (BBS) Score
时间窗: Change from baseline to end of intervention, up to 12 weeks
The Berg Balance Scale (BBS) is a 14-item performance-based measure of static and dynamic balance. Each item is scored 0-4 based on the participant's ability to perform tasks such as sitting to standing, transfers, standing unsupported with eyes closed, turning, and single-leg stance. Total scores range from 0 to 56, with higher scores indicating better balance function. Lower scores are associated with increased fall risk.
次要结局
- Change in Timed Up and Go (TUG) Test(Change from baseline to end of intervention, up to 12 weeks)
- Change in Grip Strength(Change from baseline to end of intervention, up to 12 weeks)
- Change in Balance Performance Measured by InBody Balance Trainer(Change from baseline to end of intervention, up to 12 weeks)
- Change in Shape Trail Test (STT) Part A and Part B Completion Time(Change from baseline to end of intervention, up to 12 weeks)
研究者
Zhide Liang
Doctoral Student / Study Coordinator
Hainan Medical College