Visual Impairment and Blindness (Excl Colour Blindness)NCT06450340
A Trial of Tai Chi Intervention for Youngsters with Visual Impairments
A study testing Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing. in people with Visual Impairment and Blindness (Excl Colour Blindness), run by Yanyun Zhang at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment and Blindness (Excl Colour Blindness)
- What is being tested?
- Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to 8 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- The exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou School For The Visually Impaired
Guangzhou, Guangdong, 510550
About this study
Official title: 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.
Read the 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)
- Being tested
- Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.
- Keywords
- Tai Chi, physical fitness, sleep quality, quality of life
- Medical subject headings
- Vision Disorders, Blindness, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.Behavioural
Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi exercise group | Experimental | Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Tai Chi exercise group. Receives: Behavioral: Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing. |
| Jogging group | Other | Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Jogging group. Receives: Behavioral: Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brockport Physical Fitness Test (BPFT)
BPFT is a physical fitness test for youngsters with disabilities, including a section for youngsters with visual impairments.
Measured: 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 outcomes (2)
36-Item Short-Form Health Survey
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.
Measured: 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)
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.
Measured: One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start22 Apr 2024
- Primary completion31 Jul 2024
- Study completion8 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Impairment and Blindness (Excl Colour Blindness)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanyun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanyun Zhang, Guangzhou University of Chinese Medicine
- Investigators
- Jian Zheng, Master, Study director, Master Instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450340
- Sponsor's protocol ID
- PJ-XS-20240422-003
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tai Chi on Health Fitness and Quality of Life in Youngsters with Visual Impairments: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06450340
- Acronym / sponsor ID
- PJ-XS-20240422-003
- Keywords
- Tai Chi, physical fitness, sleep quality, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yanyun ZhangUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 10 Jun 2024 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi exercise group | Experimental | Behavioral: Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Tai Chi exercise group. |
| Jogging group | Other | Behavioral: Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.Sessions lasted 60 minutes each and took place three times a week for 12 weeks for Jogging group. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- The exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.
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 |
|---|---|---|
| Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups. | Behavioural | Jogging group, Tai Chi exercise group |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian Zheng, Master study director
Master Instructor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing. in people with Visual Impairment and Blindness (Excl Colour Blindness), run by Yanyun Zhang 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 14 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 14 Nov 2024.