- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06200805
ai Chi Reduces Insomnia in College Students: Exploring Inflammatory Factor Roles
A Study on the Intervention Effect of Tai Chi on College Students With Insomnia and the Potential Role of Inflammatory Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Physical activity: was measured using the Physical activity rating scale-3 (PARS-3). The scale has a revised by Liang Deqing et al. with a retest reliability of 0.82. The scale determines the amount of exercise in terms of intensity, time, and frequency of participation in physical activities. Exercise volume = exercise intensity × time × frequency, intensity and frequency are scored on a scale of 1 to 5, assigning 1 to 5 points respectively, and time is scored on a scale of 1 to 5, assigning 0 to 4 points respectively. The score range of the scale was 0-100 points, and the score of ≤19 points was low exercise, 20-42 points was medium exercise, and ≥43 points was high exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Anhui
-
Hefei, Anhui, China, 230000
- Anhui Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Intensity Taijiquan Exercise Group
60 minutes of tai chi exercise 5 times a week
|
24-Style Taijiquan as an Intervention for College Students with Insomnia
|
|
Experimental: Moderate Intensity Taijiquan Exercise Group
60 minutes of tai chi exercise 3 times a week
|
24-Style Taijiquan as an Intervention for College Students with Insomnia
|
|
No Intervention: control subjects
The control group did not implement any intervention and maintained a normal life and study status.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Role effects of tai chi intervention in college students with insomnia
Time Frame: Minimum 12 weeks
|
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
Time Frame: Minimum 12 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WLan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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