NCT07259694

Brief Summary

This study aims to investigate the effects and underlying mechanisms of traditional exercise interventions on the physical and mental health of individuals with hearing impairments. A randomized controlled trial will be conducted with 90 participants who will be randomly assigned to one of three groups: a Tai Chi intervention group, a Baduanjin intervention group, or a control group. The Tai Chi group will receive a 12-week simplified 24-form Tai Chi training program, while the Baduanjin group will undergo standardized Baduanjin training. The control group will participate in regular school physical education classes. This study seeks to evaluate the potential health benefits and mechanisms of traditional exercise programs within the hearing-impaired population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

November 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 20, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

Hearing-Impaired

Outcome Measures

Primary Outcomes (12)

  • Modified Romberg Test

    Assessment of static balance ability using the modified Romberg test administered before and after the intervention.

    Month 3

  • Y-Balance Test

    Evaluation of dynamic balance and lower-limb functional stability using the Y-Balance test at baseline and post-intervention

    Month 3

  • 30-Second Sit-to-Stand Test

    Measurement of lower-limb muscular endurance based on the number of sit-to-stand repetitions completed in 30 seconds

    Month 3

  • Step Test

    Assessment of cardiorespiratory fitness using a standardized step test administered at baseline and post-intervention

    Month 3

  • Reaction Time Test

    Evaluation of psychomotor response speed using a computerized reaction time test before and after the intervention

    Month 3

  • Self-Rated Depression Scale (SDS)

    Assessment of depressive symptoms using the SDS at baseline and post-intervention

    Month 3

  • Self-Rated Anxiety Scale (SAS)

    Evaluation of anxiety symptoms using the SAS before and after the intervention

    Month 3

  • General Self-Efficacy Scale (GSES)

    Measurement of perceived self-efficacy using the GSES at baseline and post-intervention.

    Month 3

  • WHOQOL-BREF

    Assessment of quality of life across multiple domains using the WHOQOL-BREF questionnaire administered before and after the intervention

    Month 3

  • Resting Heart Rate

    Measurement of resting heart rate was assessed in a seated position at baseline and post-intervention

    Month 3

  • Blood Pressure

    Assessment of systolic and diastolic blood pressure using a standardized automated device before and after the intervention

    Month 3

  • Body Mass Index (BMI)

    Calculation of BMI based on measured height and weight before and after the intervention.

    Month 3

Study Arms (3)

Taichi

EXPERIMENTAL
Behavioral: Taichi

Baduanjin

EXPERIMENTAL
Behavioral: Baduanjin

Control Group

NO INTERVENTION

Interventions

TaichiBEHAVIORAL

Participants in the Tai Chi group will receive a 12-week simplified 21-form Tai Chi training program. The intervention will consist of supervised sessions conducted three times per week, each lasting approximately 60 minutes. Sessions will include a standardized warm-up, instruction and practice of the 21-form Tai Chi routine, and a brief cool-down period. All training will be delivered by certified Tai Chi instructors experienced in working with individuals with visual impairments. Attendance and adherence will be monitored throughout the intervention period.

Taichi
BaduanjinBEHAVIORAL

Participants in the Baduanjin group will undergo a 12-week standardized Baduanjin training program. The intervention will be delivered three times per week, with each supervised session lasting approximately 60 minutes. Training sessions will include a structured warm-up, guided practice of the standardized Baduanjin routine, and a brief cool-down period. All sessions will be led by qualified instructors with experience working with visually impaired individuals. Participant attendance and adherence will be recorded throughout the intervention period.

Baduanjin

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral hearing loss greater than 70 dB.
  • No cognitive impairment and able to understand and comply with study procedures.

You may not qualify if:

  • Neurological disorders affecting balance.
  • Severe cardiovascular diseases.
  • Significant musculoskeletal or joint disorders.
  • Participation in regular exercise training within the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science

Changchun, Jilin, 130022, China

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 2, 2025

Study Start

November 24, 2025

Primary Completion

January 24, 2026

Study Completion

February 1, 2026

Last Updated

December 2, 2025

Record last verified: 2025-11

Locations