Tai Chi Intervention for Balance Function in Older Adults: Predictive and Modifying Roles of Circadian Age
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
調査の概要
詳細な説明
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.
STATISTICAL ANALYSIS A sample size of 90 (45 per group) provides >80% power to detect a standardized effect size of d=0.50 in Berg Balance Scale change at week 12, assuming α=0.05 (two-sided) and 20% attrition. The primary analysis follows the intention-to-treat principle using linear mixed-effects models adjusted for baseline score, age, sex, and circadian age acceleration, with class as a random effect for the Tai Chi group. Exploratory analyses include circadian age × group interaction terms.
LONG-TERM FOLLOW-UP After the 12-week intervention, participants are invited to enter a long-term health database with periodic follow-ups tracking balance function, fall events, and overall health status.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Zhide Liang, MS
- 電話番号：0853-65597656
- メール：p2516238@mpu.edu.mo
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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Yang-style 24-form Tai Chi taught by a nationally certified master coach.
Classes are offered five days per week, with participants required to attend at least three sessions per week, for a total of 12 weeks (target: ≥36 sessions).
Each 60-minute session includes a 10-minute warm-up, 35 minutes of Tai Chi practice, 10 minutes of cool-down (including standing meditation and breathing exercises), and 5 minutes for questions and home practice reminders.
Class size is limited to 10-15 participants.
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アクティブコンパレータ：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.
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Structured health education program delivered by professional medical and health management staff.
Seminars cover topics including nutrition and dietary guidance, chronic disease management (hypertension, diabetes), fall prevention strategies, safe medication use, and general health literacy for older adults.
The intervention runs for 12 weeks.
Participants receive the same health screening, evaluation, and feedback benefits as the Tai Chi group.
Free Tai Chi classes are offered to this group after the intervention period ends.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Berg Balance Scale (BBS) Score
時間枠：Change from baseline to end of intervention, up to 12 weeks
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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.
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Change from baseline to end of intervention, up to 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Single-Leg Eye-Closed Standing Time
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Static balance is assessed by measuring the time (in seconds) participants can maintain single-leg standing with eyes closed.
Both legs are tested.
Longer times indicate better static balance and proprioception.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Vertical Jump Height
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Vertical jump test measures lower-extremity power and neuromuscular function.
Participants perform three consecutive jumps, and the maximum jump height (in centimeters) is recorded.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Reaction Time
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Reaction time test measures central nervous system processing speed using a portable reaction time device.
Faster reaction times are associated with lower fall risk and better cognitive processing.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Activities-Specific Balance Confidence (ABC) Scale
時間枠：Change from baseline to end of intervention, up to 12 weeks
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The ABC Scale is a 16-item self-report measure of balance confidence during specific activities (e.g., walking, reaching, climbing stairs).
Each item is rated 0-100%, with higher scores indicating greater balance confidence.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Geriatric Depression Scale (GDS-15) Score
時間枠：Change from baseline to end of intervention, up to 12 weeks
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The 15-item Geriatric Depression Scale (GDS-15) screens for depressive symptoms in older adults.
Total scores range from 0 to 15, with scores ≥5 suggesting depression.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Generalized Anxiety Disorder Scale (GAD-7) Score
時間枠：Change from baseline to end of intervention, up to 12 weeks
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The 7-item Generalized Anxiety Disorder Scale (GAD-7) measures anxiety severity.
Total scores range from 0 to 21, with scores ≥10 indicating moderate-to-severe anxiety.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Montreal Cognitive Assessment (MoCA) Score
時間枠：Change from baseline to end of intervention, up to 12 weeks
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The Montreal Cognitive Assessment (MoCA) is a 30-point cognitive screening tool covering visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation.
Scores ≥26 are considered normal cognitive function.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
時間枠：Change from baseline to end of intervention, up to 12 weeks
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The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality over the past month.
Total scores range from 0 to 21, with scores >5 indicating poor sleep quality.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Timed Up and Go (TUG) Test
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Functional mobility and dynamic balance test.
Participants stand from an armed chair, walk 3 meters, turn, walk back, and sit down.
Time to complete the task is recorded in seconds.
Longer times indicate poorer mobility and higher fall risk.
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Change from baseline to end of intervention, up to 12 weeks
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Change in Grip Strength
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Maximum grip strength measured using a handheld dynamometer, in kilograms. Three trials per hand; maximum value recorded. Higher values indicate greater muscle strength. Time Frame: Change from baseline to 12 weeks |
Change from baseline to end of intervention, up to 12 weeks
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Change in Balance Performance Measured by InBody Balance Trainer
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Static balance assessed via center-of-pressure trajectory recorded by the InBody Balance Trainer during quiet standing, reported in millimeters.
Shorter path length indicates better postural control.
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Change from baseline to end of intervention, up to 12 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Blood Metabolomic and Proteomic Profiles
時間枠：Change from baseline to end of intervention, up to 12 weeks
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Targeted and untargeted metabolomics analysis of serum and plasma samples; proteomics analysis (Olink/SomaScan platform) including inflammatory markers (IL-6, TNF-α, hs-CRP), aging-related proteins (GDF-15), and neurotrophic factors (BDNF).
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Change from baseline to end of intervention, up to 12 weeks
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Baseline Circadian Age Acceleration (AgeAccel_z)
時間枠：Baseline
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Circadian age acceleration is derived from 7-day wrist-worn accelerometer (ActiGraph) data processed using the GGIR R package.
AgeAccel_z is the standardized residual of circadian age regressed on chronological age, reported in standard deviation units (z-score).
Positive values indicate accelerated circadian aging relative to chronological age.
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Baseline
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Changes in Serum Metabolomic Profiles
時間枠：Change from baseline to 12 weeks
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Targeted and untargeted metabolomics analysis of serum samples.
Differential metabolites between groups are identified using fold change (|FC|>1.2) and false discovery rate (FDR<0.1).
Results are reported as the number of significantly altered metabolites and enriched metabolic pathways.
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Change from baseline to 12 weeks
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Changes in Serum Proteomic Profiles
時間枠：Change from baseline to 12 weeks
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Proteomic analysis using Olink or SomaScan platform measuring inflammation-related proteins (IL-6, TNF-α, hs-CRP, IL-1β), aging-related proteins (GDF-15, IGFBP-3), and neurotrophic factors (BDNF, NGF).
Differential proteins between groups are identified using fold change (|FC|>1.5)
and false discovery rate (FDR<0.1).
Results are reported as the number of significantly altered proteins.
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Change from baseline to 12 weeks
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Baichao Xu, PhD、Hainan Medical College
- スタディディレクター：Ziheng Ning, PhD、Macao Polytechnic University
研究記録日
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研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
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学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Tai Chi Exerciseの臨床試験
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