RCT on Traditional Exercise Interventions for Physical and Mental Health in Hearing-Impaired Individuals

November 20, 2025 updated by: Guang Yang, Prof. Dr., Northeast Normal University

Randomized Controlled Trial on the Effects of Traditional Exercise Programs on the Physical and Mental Health of Hearing-Impaired Individuals

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130022
        • Faculty of Sports Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Taichi
Behavioral: Taichi
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.
Experimental: Baduanjin
Behavioral: Baduanjin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Romberg Test
Time Frame: Month 3
Assessment of static balance ability using the modified Romberg test administered before and after the intervention.
Month 3
Y-Balance Test
Time Frame: Month 3
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
Time Frame: Month 3
Measurement of lower-limb muscular endurance based on the number of sit-to-stand repetitions completed in 30 seconds
Month 3
Step Test
Time Frame: Month 3
Assessment of cardiorespiratory fitness using a standardized step test administered at baseline and post-intervention
Month 3
Reaction Time Test
Time Frame: Month 3
Evaluation of psychomotor response speed using a computerized reaction time test before and after the intervention
Month 3
Self-Rated Depression Scale (SDS)
Time Frame: Month 3
Assessment of depressive symptoms using the SDS at baseline and post-intervention
Month 3
Self-Rated Anxiety Scale (SAS)
Time Frame: Month 3
Evaluation of anxiety symptoms using the SAS before and after the intervention
Month 3
General Self-Efficacy Scale (GSES)
Time Frame: Month 3
Measurement of perceived self-efficacy using the GSES at baseline and post-intervention.
Month 3
WHOQOL-BREF
Time Frame: Month 3
Assessment of quality of life across multiple domains using the WHOQOL-BREF questionnaire administered before and after the intervention
Month 3
Resting Heart Rate
Time Frame: Month 3
Measurement of resting heart rate was assessed in a seated position at baseline and post-intervention
Month 3
Blood Pressure
Time Frame: Month 3
Assessment of systolic and diastolic blood pressure using a standardized automated device before and after the intervention
Month 3
Body Mass Index (BMI)
Time Frame: Month 3
Calculation of BMI based on measured height and weight before and after the intervention.
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northeast Normal University

Collaborators

Changchun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 24, 2025

Primary Completion (Estimated)

January 24, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEE202602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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