跳至主要内容
临床试验/NCT06200805
NCT06200805已完成不适用

A Study on the Intervention Effect of Tai Chi on College Students With Insomnia and the Potential Role of Inflammatory Factors

Anhui Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Role effects of tai chi intervention in college students with insomnia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
17 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

High Intensity Taijiquan Exercise Group

Experimental

60 minutes of tai chi exercise 5 times a week

干预措施: tai ji quan (Behavioral)

Moderate Intensity Taijiquan Exercise Group

Experimental

60 minutes of tai chi exercise 3 times a week

干预措施: tai ji quan (Behavioral)

control subjects

No Intervention

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

结局指标

主要结局

Role effects of tai chi intervention in college students with insomnia

时间窗: 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

Changes in inflammatory factors before and after tai chi intervention

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Anhui Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Hai Lan

Chief Researcher

Anhui Medical University

研究点 (1)

Loading locations...

相似试验