Hearing-ImpairedNCT07259694
RCT on Traditional Exercise Interventions for Physical and Mental Health in Hearing-Impaired Individuals
A study testing Taichi and Baduanjin in people with Hearing-Impaired, run by Northeast Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Hearing-Impaired
- What is being tested?
- Taichi and Baduanjin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Bilateral hearing loss greater than 70 dB.
- No cognitive impairment and able to understand and comply with study procedures.
Who cannot join
- Neurological disorders affecting balance.
- Severe cardiovascular diseases.
- Significant musculoskeletal or joint disorders.
- Participation in regular exercise training within the past 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hearing-Impaired
- Being tested
- Taichi, Baduanjin
- Keywords
- Hearing-Impaired
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaichiBehavioural
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.
BaduanjinBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Taichi | Experimental | Not described Receives: Behavioral: Taichi |
| Baduanjin | Experimental | Not described Receives: Behavioral: Baduanjin |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Romberg Test
Assessment of static balance ability using the modified Romberg test administered before and after the intervention.
Measured: Month 3
Y-Balance Test
Evaluation of dynamic balance and lower-limb functional stability using the Y-Balance test at baseline and post-intervention
Measured: 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
Measured: Month 3
Step Test
Assessment of cardiorespiratory fitness using a standardized step test administered at baseline and post-intervention
Measured: Month 3
Reaction Time Test
Evaluation of psychomotor response speed using a computerized reaction time test before and after the intervention
Measured: Month 3
Self-Rated Depression Scale (SDS)
Assessment of depressive symptoms using the SDS at baseline and post-intervention
Measured: Month 3
Self-Rated Anxiety Scale (SAS)
Evaluation of anxiety symptoms using the SAS before and after the intervention
Measured: Month 3
General Self-Efficacy Scale (GSES)
Measurement of perceived self-efficacy using the GSES at baseline and post-intervention.
Measured: Month 3
WHOQOL-BREF
Assessment of quality of life across multiple domains using the WHOQOL-BREF questionnaire administered before and after the intervention
Measured: Month 3
Resting Heart Rate
Measurement of resting heart rate was assessed in a seated position at baseline and post-intervention
Measured: Month 3
Blood Pressure
Assessment of systolic and diastolic blood pressure using a standardized automated device before and after the intervention
Measured: Month 3
Body Mass Index (BMI)
Calculation of BMI based on measured height and weight before and after the intervention.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start24 Nov 2025 (estimated)
- Primary completion24 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing-ImpairedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Changchun University
- Responsible party
- Principal investigator, Guang Yang, Prof. Dr., Northeast Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259694
- Sponsor's protocol ID
- CCEE202602
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effects of Traditional Exercise Programs on the Physical and Mental Health of Hearing-Impaired Individuals
- ClinicalTrials.gov ID
- NCT07259694
- Acronym / sponsor ID
- CCEE202602
- Conditions
- Hearing-Impaired
- Keywords
- Hearing-Impaired
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Collaborators
- Changchun University
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 24 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taichi | Experimental | Behavioral: Taichi |
| Baduanjin | Experimental | Behavioral: Baduanjin |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bilateral hearing loss greater than 70 dB.
- No cognitive impairment and able to understand and comply with study procedures.
Key exclusion criteria (4 listed)
- Neurological disorders affecting balance.
- Severe cardiovascular diseases.
- Significant musculoskeletal or joint disorders.
- Participation in regular exercise training within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaichiParticipants 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. | Behavioural | Taichi |
| BaduanjinParticipants 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. | Behavioural | Baduanjin |
Primary outcome
Modified Romberg Test
Time frame: Month 3
Assessment of static balance ability using the modified Romberg test administered before and after the intervention.
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
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
Step Test
Time frame: Month 3
Assessment of cardiorespiratory fitness using a standardized step test administered at baseline and post-intervention
Reaction Time Test
Time frame: Month 3
Evaluation of psychomotor response speed using a computerized reaction time test before and after the intervention
Self-Rated Depression Scale (SDS)
Time frame: Month 3
Assessment of depressive symptoms using the SDS at baseline and post-intervention
Self-Rated Anxiety Scale (SAS)
Time frame: Month 3
Evaluation of anxiety symptoms using the SAS before and after the intervention
General Self-Efficacy Scale (GSES)
Time frame: Month 3
Measurement of perceived self-efficacy using the GSES at baseline and post-intervention.
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
Resting Heart Rate
Time frame: Month 3
Measurement of resting heart rate was assessed in a seated position at baseline and post-intervention
Blood Pressure
Time frame: Month 3
Assessment of systolic and diastolic blood pressure using a standardized automated device before and after the intervention
Body Mass Index (BMI)
Time frame: Month 3
Calculation of BMI based on measured height and weight before and after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taichi and Baduanjin in people with Hearing-Impaired, run by Northeast Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Romberg Test (time frame: Month 3). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.