Traditional Exercise RCT in Visually Impaired Adults

December 1, 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 Visually Impaired Individuals

This study aims to investigate the benefits and underlying mechanisms of traditional exercise interventions on the physical and mental health of individuals with visual impairments. A randomized controlled trial design will be employed, enrolling 90 visually impaired 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 undergo a 12-week simplified 21-form Tai Chi training program, while the Baduanjin group will receive standardized Baduanjin training. The control group will participate in regular school physical education classes. Eligible participants are university students with visual impairments, defined as having visual acuity ≤ 0.05 or a visual field radius ≤ 10 degrees.

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • University students with visual impairment, defined as visual acuity ≤ 0.05 or a visual field radius ≤ 10 degrees.
  • Able to ambulate independently without assistance.
  • No severe cardiovascular diseases.

Exclusion Criteria:

  • Presence of severe physical illnesses or comorbid conditions that may affect participation.
  • History of psychiatric disorders.
  • Participation in other structured exercise training programs within the past three 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: 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.
Experimental: Baduanjin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single-Leg Stance Test
Time Frame: Month 3
Assessment of static balance ability by measuring the duration participants can maintain a single-leg stance before and after the intervention.
Month 3
Timed Up-and-Go (TUG) Test
Time Frame: Month 3
Evaluation of dynamic balance and functional mobility using the timed up-and-go test, recorded at baseline and post-intervention.
Month 3
Berg Balance Scale (BBS)
Time Frame: Month 3
Measurement of overall balance performance using the 14-item Berg Balance Scale, administered before and after the intervention.
Month 3
Six-Minute Walk Test (6MWT)
Time Frame: Month 3
Assessment of cardiorespiratory endurance using the six-minute walk test at baseline and following the intervention.
Month 3
Handgrip Strength Test
Time Frame: Month 3
Evaluation of upper-limb muscular strength using a calibrated handgrip dynamometer, performed before and after the intervention.
Month 3
Flexibility Test
Time Frame: Month 3
Measurement of lower-body flexibility using a standardized sit-and-reach test conducted at baseline and post-intervention.
Month 3
Self-Rated Depression Scale (SDS)
Time Frame: Month 3
Assessment of depressive symptoms using the Self-Rated Depression Scale before and after the intervention.
Month 3
Self-Rated Anxiety Scale (SAS)
Time Frame: Month 3
Evaluation of anxiety symptoms using the Self-Rated Anxiety Scale administered at baseline and post-intervention.
Month 3
General Self-Efficacy Scale (GSES)
Time Frame: Month 3
Measurement of perceived self-efficacy using the General Self-Efficacy Scale at baseline and after the intervention.
Month 3
WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame: Month 3
Assessment of overall quality of life across physical, psychological, social, and environmental domains using the WHOQOL-BREF questionnaire, conducted 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 (Actual)

November 20, 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

December 1, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCEE2026

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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