Clinical Research Directory

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

Sponsor: Beijing Sport University

Summary

What are the requirements for participating in this study? 1. Age 40 to 69, gender unlimited; 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); 4\. 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 are not eligible to participate in this study if you meet any of the following criteria: 1. Exclude diseases that affect sleep (such as tumors, dementia, obstructive sleep apnea, etc.); 2. Taking medications that may affect sleep (such as steroid hormones, sleeping pills, psychotropic drugs); 3. Abuse of alcohol or drugs in the last 3 months; 4. Liver or kidney dysfunction; 5. History of severe cardiovascular and cerebrovascular diseases; 6. History of mental illness; 7. Expect to work night shifts or travel across time zones or sleep irregularly during the study period; 8. Participated in other intervention clinical trials, including drugs, nutritional preparations and medical devices, within 3 months before the study. What will I experience if I participate in this study? If eligible, participants will be randomly assigned by physicians to one of two study phases: the screening and baseline assessment phase, or the intervention and follow-up phase. The trial consists of three phases, each containing two phases (experimental or control, lasting 1-2 weeks). After enrollment, participants will be randomly assigned to either the Tai Chi intervention group or the walking control group. Throughout the study, participants must cooperate with physicians to complete relevant questionnaires and attend scheduled follow-up visits. What might be the benefits of participating in this study? The research team will cover all expenses for the exercise program. Participants will receive free exercise training, physiological counseling, and standardized assessments throughout the study, including follow-up sessions. Our previous sports medicine research shows that 12 weeks of Tai Chi therapy can significantly improve insomnia symptoms. What are the risks of participating in this study? Participants who have not exercised for a long time may have adverse reactions such as muscle pain and joint pain caused by exercise in the early stage of the experiment or during the study, or even lead to the termination of the experiment. Is participation in this study mandatory? No, participation in this study is entirely voluntary. Can I quit the study midway? Yes, you can opt out at any time, and this will not affect your legal right to continue regular checkups or treatments. Are my personal information confidential? Your personal privacy will be strictly protected within the bounds of applicable laws. Monitoring officers, auditors, ethics committees, and management authorities shall be permitted to directly access participants 'original medical records to verify clinical trial procedures and data, provided such access does not violate applicable laws and regulations or infringe upon participants' privacy. Throughout the study, participants have the right to withdraw from the research at any time without facing discrimination, retaliation, or disruption of medical services. All personal information collected during the study remains confidential. Participants are entitled to consult our physicians with any questions at any time. Patient Statement (Please tick in parentheses): 1. I have reviewed the relevant research materials for this study (version v1.0)···········□ 2. I have carefully considered the matter, consulted a doctor about the relevant issues, and received satisfactory answers······□ 3. 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·····□ 4. 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. ·······················□ 5. I agree to participate in this study·····························□

Official title: Tai Chi Improves Sleep Quality in Patients With Mild to Moderate Chronic Insomnia

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