NCT06450340

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

June 1, 2024

Last Update Submit

November 12, 2024

Conditions

Keywords

Tai Chiphysical fitnesssleep qualityquality of life

Outcome Measures

Primary Outcomes (1)

  • Brockport Physical Fitness Test (BPFT)

    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 Outcomes (2)

  • 36-Item Short-Form Health Survey

    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)

    One measurement was made from the day of random grouping, and another measurement was made within one week after 12 weeks of exercise intervention.

Study Arms (2)

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.

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.

Behavioral: Moderate-intensity aerobic exercise refers to rhythmic and long-lasting exercise with increased heart rate, slight sweating and slight wheezing.

Interventions

Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups.

Jogging groupTai Chi exercise group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou School For The Visually Impaired

Guangzhou, Guangdong, 510550, China

Location

MeSH Terms

Conditions

Vision DisordersBlindnessSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Jian Zheng, Master

    Master Instructor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary rehabilitation therapist

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 10, 2024

Study Start

April 22, 2024

Primary Completion

July 31, 2024

Study Completion

September 8, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations