Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07567976

Tai Chi Intervention for Balance Function in Older Adults: Predictive and Modifying Roles of Circadian Age

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tai Chi Exercise

Behavioral

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.

Health Education

Behavioral

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.

Primary outcomes

  1. Change in Berg Balance Scale (BBS) Score

    Time frame: 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.

Secondary outcomes

  1. Change in Timed Up and Go (TUG) Test

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  2. Change in Grip Strength

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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

  3. Change in Balance Performance Measured by InBody Balance Trainer

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  4. Change in Single-Leg Eye-Closed Standing Time

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  5. Change in Vertical Jump Height

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    Vertical jump test measures lower-extremity power and neuromuscular function. Participants perform three consecutive jumps, and the maximum jump height (in centimeters) is recorded.

  6. Change in Reaction Time

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  7. Change in Activities-Specific Balance Confidence (ABC) Scale

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  8. Change in Geriatric Depression Scale (GDS-15) Score

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  9. Change in Generalized Anxiety Disorder Scale (GAD-7) Score

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

  10. Change in Shape Trail Test (STT) Part A and Part B Completion Time

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    The Shape Trail Test (STT) is a culturally adapted variant of the Trail Making Test developed for Chinese populations, avoiding reliance on the Latin alphabet. In Part A, participants connect numbered circles in sequence; in Part B, they alternate between circles and squares while ignoring the numbers. Completion time for each part is recorded in seconds, with longer times indicating poorer processing speed and executive function. STT-A and STT-B completion times are reported separately.

  11. Change in Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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.

Other outcomes

  1. Baseline Circadian Age Acceleration (AgeAccel_z)

    Time frame: Baseline

    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.

  2. Changes in Blood Metabolomic and Proteomic Profiles

    Time frame: Change from baseline to end of intervention, up to 12 weeks

    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).

  3. Changes in Serum Metabolomic Profiles

    Time frame: Change from baseline to 12 weeks

    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.

  4. Changes in Serum Proteomic Profiles

    Time frame: Change from baseline to 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhide Liang, MS

CONTACT

[email protected]

0853-65597656

Sponsors and collaborators

Lead sponsor

Zhide Liang

Other

Collaborators

  • Macao Polytechnic University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.