NCT07567976

Brief Summary

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, cognitive function, psychological well-being, and sleep quality. The study also explores the predictive and modifying roles of circadian age on intervention outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Tai ChiTai Ji QuanMind-Body ExerciseOlder AdultsFall PreventionCircadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • Change in Berg Balance Scale (BBS) Score

    The Berg Balance Scale (BBS) is a 14-item performance-based measure of static and dynamic balance in older adults. 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.

    Change from baseline to end of intervention, up to 12 weeks

Secondary Outcomes (13)

  • 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 Short Physical Performance Battery (SPPB) Score

    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 Single-Leg Eye-Closed Standing Time

    Change from baseline to end of intervention, up to 12 weeks

  • +8 more secondary outcomes

Other Outcomes (3)

  • Change in Circadian Age Acceleration (AgeAccel_z)

    Baseline

  • Change in Prefrontal Brain Activation Measured by fNIRS

    Change from baseline to end of intervention, up to 12 weeks

  • Changes in Blood Metabolomic and Proteomic Profiles

    Change from baseline to end of intervention, up to 12 weeks

Study Arms (2)

Tai Chi Group

EXPERIMENTAL

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.

Behavioral: Tai Chi Exercise

Health Education Control Group

ACTIVE COMPARATOR

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.

Behavioral: Health Education

Interventions

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.

Tai Chi Group

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.

Health Education Control Group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Aquatic Therapy

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Baichao Xu, PhD

    Hainan Medical College

    STUDY DIRECTOR
  • Ziheng Ning, PhD

    Macao Polytechnic University

    STUDY DIRECTOR

Central Study Contacts

Zhide Liang, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-arm parallel randomized controlled trial. Participants are randomly assigned in a 1:1 ratio to either the Tai Chi intervention group or the health education control group. Both groups undergo the intervention concurrently for 12 weeks. After the intervention, the control group is offered free Tai Chi classes to ensure ethical equipoise.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Student / Study Coordinator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04