NCT06200805

Brief Summary

College student volunteers were recruited from a university in Anhui Province, China, and screened by the Pittsburgh sleep quality index (PSQI) scale, and those with PSQI scores higher than 7 were considered to have clinical insomnia, and insomniac college students screened were subjected to a 24-week 24-form taijiquan intervention, and the rest of the insomniac volunteers were randomly divided into the fast-walking group and the control group. As the most common form of physical exercise for college students and the easiest aerobic exercise, brisk walking was chosen as an intervention for insomniac college students to better compare the efficacy of tai chi with that of general aerobic exercise for insomnia. The taijiquan group performed taijiquan exercise three times a week for 60 minutes each time, the brisk walking group performed brisk walking training three times a week for 60 minutes each time, and the control group did not carry out any intervention and maintained a normal life and study status. Before the intervention, questionnaires were filled out and fasting elbow venous blood was drawn, and the staff uniformly explained the intervention-related contents and precautions, and after 24 weeks of intervention, the post-test questionnaires and fasting venous blood were filled out centrally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

December 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

December 9, 2023

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Role effects of tai chi intervention in college students with insomnia

    Insomnia: measured by PSQI scale. The scale was developed by Buysse et al, a neurologist at the University of Pittsburgh, USA, and has an overall internal consistency Cronbach's ɑ coefficient of 0.83.The scale was used to assess the quality of sleep of an individual in the last month, and consists of 19 self-assessed and 5 other-assessed entries, for a total of 24 items, where the 19th entry and the five other-assessed entries do not participate in the scoring. The 18 scoring items include seven dimensions: subjective sleep quality, time to sleep, sleep efficiency, sleep disorders, hypnotic drug use, and daytime functioning. Each dimension is scored on a scale of 0-3, and the cumulative score is the total PSQI score, which ranges from 0-21, with higher scores indicating poorer sleep quality, and PSQI scores greater than 7 are considered clinical insomnia. Use of this scale to assess the improvement of insomnia in insomniac college students using taijiquan

    Minimum 12 weeks

  • Changes in inflammatory factors before and after tai chi intervention

    Fasting elbow vein blood of 2 ml was collected from college students in the tai chi group, the fast walking group, and the control group. 2 ml of blood was tested using Luminex multifactor assay technology. The levels of IL-2, IL-4, IL-6, IL-10, TNF-ɑ, IFN-Y, IL-8, IL-13, and IL-1 in the supernatant were measured. Inflammatory factor data before and after exercise were analyzed in each group to observe the level of inflammatory factor changes before and after taijiquan intervention and to explore the role played by inflammatory factor changes in taijiquan intervention for insomniac college students.

    Minimum 12 weeks

Study Arms (3)

High Intensity Taijiquan Exercise Group

EXPERIMENTAL

60 minutes of tai chi exercise 5 times a week

Behavioral: tai ji quan

Moderate Intensity Taijiquan Exercise Group

EXPERIMENTAL

60 minutes of tai chi exercise 3 times a week

Behavioral: tai ji quan

control subjects

NO INTERVENTION

The control group did not implement any intervention and maintained a normal life and study status.

Interventions

tai ji quanBEHAVIORAL

24-Style Taijiquan as an Intervention for College Students with Insomnia

High Intensity Taijiquan Exercise GroupModerate Intensity Taijiquan Exercise Group

Eligibility Criteria

Age17 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meet the diagnostic criteria of insomnia i.e. PSQI score ≥ 7;
  • Age between 18 and 25 years old; ③ Exercise of the study subjects is low exercise i.e. PARS-3 score ≤ 19;
  • Have not received any psychological and pharmacological treatments in the past one year;
  • Have no visceral diseases, normal vision and hearing; ⑥ Have good physical fitness and can perform basic intensity of physical exercise; ⑦ Have signed the informed consent form.

You may not qualify if:

  • Recent cardiovascular disease, musculoskeletal disease and other diseases that affect normal sports training;
  • Serious mental illness; ③ Antibiotics within the past three months; ④ Serious autoimmune disease; ⑤ Those who refuse to participate in the research project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Researcher

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 11, 2024

Study Start

May 15, 2024

Primary Completion

June 20, 2024

Study Completion

July 20, 2024

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations