- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06450340
A Trial of Tai Chi Intervention for Youngsters with Visual Impairments
November 12, 2024 updated by: Yanyun Zhang
Effects of Tai Chi on Health Fitness and Quality of Life in Youngsters with Visual Impairments: a Randomized Controlled Trial
Investigators conducted a single-blind, randomized trial of Taijiquan exercise as compared with a control intervention consisting of wellness education and jogging for youngsters with visual impairments.
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups.
The primary end point was a change in the Brockport Physical Fitness Test (BPFT) at the end of 12 weeks.
Secondary end points included summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Pittsburgh Sleep Quality Index (PSQI)at the end of 12 weeks.
Study Overview
Status
Completed
Detailed Description
- Brockport Physical Fitness Test (BPFT) for youngsters with visual impairments, including 20-meter lap scores, Body mass index (BMI), Dominant Grip Strength, Curl-Up, Trunk lift, Back-Saver Sit-and-Reach and Shoulder Stretch.
- Basic information about visually impaired youth, including age, gender, height, weight.
- summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
- summary scores of of the Medical Outcomes Study Pittsburgh Sleep Quality Index (PSQI)
Study Type
Interventional
Enrollment (Actual)
44
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
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510550
- Guangzhou School For The Visually Impaired
-
-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- The age ranges from 10 to 17 years old, regardless of sex.
- had no previous experience as an athlete.
- could follow simple instructions.
- could walk without assistance.
- could maintain a regular lifestyle during the experiment.
- provided informed consent.
Exclusion Criteria:
- The exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai Chi exercise group
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Tai Chi exercise group.
|
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups.
|
|
Other: Jogging group
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Jogging group.
|
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brockport Physical Fitness Test (BPFT)
Time Frame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
BPFT is a physical fitness test for youngsters with disabilities, including a section for youngsters with visual impairments.
|
One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
36-Item Short-Form Health Survey
Time Frame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
Investigators use 36-Item Short-Form Health Survey to test the quality of life of youngsters with visual impairments.
The SF-36 is scored on a scale of 0-100, with higher scores indicating better health.
|
One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
Investigators use Pittsburgh Sleep Quality Index (PSQI) to test the sleep quality of youngsters with visual impairments.
The total score of the Pittsburgh Sleep Quality Index ranges from 0 to 21, with higher scores indicating worse sleep quality.
|
One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jian Zheng, Master, Master Instructor
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)
April 22, 2024
Primary Completion (Actual)
July 31, 2024
Study Completion (Actual)
September 8, 2024
Study Registration Dates
First Submitted
June 1, 2024
First Submitted That Met QC Criteria
June 4, 2024
First Posted (Actual)
June 10, 2024
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PJ-XS-20240422-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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