Tai Chi Improves Sleep Quality in Mild to Moderate Chronic Insomnia Patients

NCT07264907 | Not Yet Recruiting

• 1 other identifier: 2025350H
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

What are the requirements for participating in this study?

1. 1.Age 40 to 69, gender unlimited;
2. 2.Insomnia symptoms (difficulty falling asleep, frequent awakenings during sleep, early morning awakening, etc.) occurring three or more times per week for three months or longer (meeting DSM-5 diagnostic criteria for chronic insomnia and International Classification of Sleep Disorders standards); 3.7 points \<ISI baseline score ≤ 21 points (mild to moderate insomnia);
3. 3.Exclude diseases that affect sleep (such as tumors, dementia, obstructive sleep apnea, etc.);
4. 4.Taking medications that may affect sleep (such as steroid hormones, sleeping pills, psychotropic drugs);
5. 5.Abuse of alcohol or drugs in the last 3 months;
6. 6.Liver or kidney dysfunction;
7. 7.History of severe cardiovascular and cerebrovascular diseases;
8. 8.History of mental illness;
9. 9.Expect to work night shifts or travel across time zones or sleep irregularly during the study period;
10. 10.Participated in other intervention clinical trials, including drugs, nutritional preparations and medical devices, within 3 months before the study.
11. 11.I have reviewed the relevant research materials for this study (version v1.0)···········□
12. 12.I have carefully considered the matter, consulted a doctor about the relevant issues, and received satisfactory answers······□
13. 13.I understand that participation in this study is voluntary and that I have the right to withdraw from this study at any time without any reason without affecting my medical treatment and rights·····□
14. 14.I understand that my relevant materials will be reviewed by the research unit or members of the strict management agency in this study. I agree to the above personnel reviewing and using my relevant materials. ·······················□
15. 15.I agree to participate in this study·····························□

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess subjective sleep quality over a 1-month period. Developed by Buysse et al. in 1989, it consists of 19 individual items categorized into 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-3 scale, with total scores ranging from 0 to 21. A total score ≥ 7 indicates poor sleep quality, while a score \< 7 reflects good sleep quality. The PSQI is recognized for its simplicity, reliability, and validity across diverse populations, including healthy individuals, patients with chronic diseases, and those with sleep disorders. It is extensively employed in clinical research, epidemiological studies, and clinical practice to evaluate sleep outcomes, particularly in fields such as medicine, psychology, public health, and complementary and altern

  8 weeks

Study Arms (1)

Intervention Group

If subjects are eligible to participate in this study, they will be randomly assigned by the doctor to undergo the following two phases, including a screening and baseline assessment period, an intervention period, and a follow-up period. The specific assessments conducted in each phase are as follows: The entire trial consists of 3 stages, with each stage comprising 2 periods (a test period or a control period, each lasting 1 week/2 weeks). After enrollment, patients will be randomly allocated to either the test period (Tai Chi) or the control period (walking). During the study, subjects will be required to cooperate with doctors to complete relevant questionnaires and follow-up assessments.

Other: Tai Chi and Walking

Interventions

Tai Chi and Walking OTHER

1. Frequency: Train three times a week on a fixed day (e.g., Monday, Wednesday, Friday) to avoid two consecutive days of no training and ensure continuity; 2. Duration: 40 minutes for the basic preparation phase, and 60 minutes for the advanced learning and integration phase (including warm-up, core training, and relaxation). 3. Attendance requirement: Participants must complete at least 19 training sessions (24 sessions over 8 weeks with an attendance rate of ≥80%). In case of absence due to special circumstances, they must complete supplementary training via online video (instructor-recorded action breakdowns) within one week, with the same duration as regular sessions.

Intervention Group

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

he study population consists of individuals aged 40 to 69 years diagnosed with insomnia, defined according to the diagnostic criteria of the International Classification of Sleep Disorders (ICSD-3) or the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible participants typically report persistent sleep disturbances (e.g., difficulty falling asleep, frequent nighttime awakenings, early-morning awakening, or non-restorative sleep) lasting at least 3 months, occurring at least 3 nights per week, and causing significant daytime impairment (such as fatigue, mood disturbances, cognitive dysfunction, or reduced work/activity capacity). This age group (40-69 years) is characterized by a high prevalence of insomnia, often associated with physiological changes (e.g., declining sleep efficiency, altered circadian rhythms), chronic comorbidities (e.g., hypertension, diabetes, musculoskeletal disorders), psychological stress, or lifestyle factors (e.g., sedentary behavior, irreg

You may qualify if:

• Age 40 to 69, gender unlimited;
• Insomnia symptoms (difficulty falling asleep, frequent awakenings during sleep, early morning awakening, etc.) occurring three or more times per week for three months or longer (meeting DSM-5 diagnostic criteria for chronic insomnia and International Classification of Sleep Disorders standards); 3.7 points \<ISI baseline score ≤ 21 points (mild to moderate insomnia);
• \. The patient is dissatisfied (option 3) or very dissatisfied (option 4) with their current sleep 5. The incubation period or wake time after falling asleep is more than 30 minutes, and the total sleep time is less than 6.5 hours per day; 6. Willing to follow the exercise prescription and coach's guidance, and cooperate with the exercise intervention for 6 weeks; 7. Being able to maintain consistent lifestyle and sleep patterns throughout the study; 8. Fixed residence and no expectation of moving or traveling within 6 weeks; 9. Sign the informed consent form.

You may not qualify if:

• Exclude diseases that affect sleep (such as tumors, dementia, obstructive sleep apnea, etc.);
• Taking medications that may affect sleep (such as steroid hormones, sleeping pills, psychotropic drugs);
• Abuse of alcohol or drugs in the last 3 months;
• Liver or kidney dysfunction;
• History of severe cardiovascular and cerebrovascular diseases;
• History of mental illness;
• Expect to work night shifts or travel across time zones or sleep irregularly during the study period;
• Participated in other intervention clinical trials, including drugs, nutritional preparations and medical devices, within 3 months before the study.

Sponsors & Collaborators

• Beijing Sport University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Tai Ji; Walking

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Xiangji X PENG, Master

CONTACT

+8615210900779; pxj0633@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11