Shanghai University of Finance and Economics
Shanghai, China
NCT Number: NCT06728904
1、 Research objective
The main objective of this study is to investigate the therapeutic effect of a comprehensive lifestyle adjustment and stress management plan based on high-intensity Tai Chi on asthma patients. The main research areas are as follows:
1) Differences in therapeutic efficacy for mild or moderate asthma patients 2) Potential therapeutic efficacy for adult populations with different weight conditions.
2、 Research significance 2.1 Theoretical significance At present, there is limited research on the rehabilitation efficacy of high-intensity Tai Chi intervention combined with stress management programs for asthma patients. Studying the intervention effects on asthma patients among Chinese university students can fill the gap in this field and lay a theoretical foundation for further applied research in China; Exploring the application effect of high-intensity Tai Chi intervention combined with stress management plan in the treatment of asthma patients may have an important impact on improving their quality of life and rehabilitation treatment, and help expand chronic disease management strategies, which has certain theoretical value.
2.2 Practical significance The intervention effect of Tai Chi and other exercise intervention methods in the rehabilitation treatment of chronic diseases has been clinically validated and has certain innovation. This study combines this type of exercise intervention with a stress management plan, which can provide more clinical evidence and facilitate scholars to conduct other applied research, further improving the exercise rehabilitation program for asthma patients. The intervention results of exercise intervention and stress management plan for college students with asthma still have certain guiding significance for the development of rehabilitation management for asthma patients.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Shanghai, China
3、 Research Methods 3.1 Main research ideas The preliminary research mainly adopts the method of literature review, completing a review of the research status, experimental methods, and measurement methods, and forming relevant theoretical foundations; The main purpose of the initial study is feasibility exploration, with a focus on evaluating participant attendance, compliance, satisfaction, and feedback. The mid-term study expanded the scope of participants and conducted a randomized controlled experiment. The study was divided into an experimental group and a control group. The experimental group received exercise intervention mainly based on Chen style Tai Chi, combined with stress management plans and health education courses. The control group received health education courses and participated in general stretching activities. Conduct data statistics for later research and propose research conclusions and recommendations based on experimental data reports.
3.2 Study Subject Selection This study focuses on asthma students from Shanghai University of Finance and Economics (including undergraduate, graduate, and doctoral students) as the subjects, and is conducted in an experimental manner. The sample size was calculated using G * power3.1 software to ensure sufficient statistical strength for this study, and the results showed that at least 20-50 subject patients need to be included.
Inclusion criteria
1) Over 18 years old; 2) Diagnosis of mild to moderate asthma for at least 6 months (meeting the lung capacity measurement criteria for mild to moderate asthma); 3) The dosage of asthma medication has been stable for the past month (if no asthma medication has been used, it also meets the inclusion criteria).
Exclusion criteria
1) Other lung diseases; 2) Only experiencing exercise-induced asthma (asthma is only triggered by exercise and there are no asthma symptoms in other situations; 3) pregnancy; (4) Due to chronic illness requiring oral hormone therapy in the past month; (5) Physical condition prohibits any exercise; And (6) recently unstable medical conditions. All ethnic groups and genders are eligible to participate in this study.
3.3 Main research methods 3.3.1 Experimental Method The research is generally divided into a feasibility study in the first stage and a randomized controlled study in the second stage.
The first stage feasibility study does not group the subjects, with the main purpose of testing their attendance, compliance, satisfaction, and feedback.
In the second stage of this study, participants will be randomly divided into a control group and an experimental group, and the specific tasks to be performed by both groups are as follows.
3.3.2 Mathematical and Statistical Methods
The entered spreadsheet data was analyzed using data analysis software (SPSS 26.0, EXCEL2021, and Prism 9.0), and the main analysis methods used were:
4、 Expected results 4.1 Chen's Tai Chi intervention combined with stress management plan intervention has a significant difference in the treatment effect on asthma patients.
4.2 There are certain differences in intervention effects among asthma patients with different body weights, physical health, and physiological function indicators.
4.3 There is a correlation between the therapeutic effect of Chen's Tai Chi intervention combined with stress management plan intervention on asthma patients and psychological and behavioral variables
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All ethnic groups and genders are eligible to participate in this study.
40-90 minutes per session, 3-5 sessions per week. 6. Each practice mainly includes basic theoretical knowledge, warm-up exercises, standing exercises, Chen style Tai Chi, and relaxation techniques. This study expects to divide the Tai Chi intervention program into three stages: the first stage is the introductory learning of simple high-intensity Chen style Tai Chi, the second stage is the combination of strength training and Chen style Tai Chi courses, and the third stage uses optional high-intensity competitive Chen style Tai Chi or Tai Chi Sword as advanced content to consolidate learning outcomes, such as the 32 style Tai Chi Sword (HR of about 120 times/minute). The intervention plan will be combined with high-intensity interval training (HIIT) to adapt Chen style Tai Chi.
Time frame: Interventions lasting 12 weeks
An FEV1 of less than 1 Liter indicates significant lung disease.
Time frame: Interventions lasting 12 weeks
A normal peak flow in adults may be between 400 and 700 L/m. In children, a normal peak flow may range from around 150 to 450 L/m.
Time frame: Interventions lasting 12 weeks
key measure for asthma control, assessing the adequacy of asthma control and track changes in control over time, either due to natural fluctuations or treatment interventions. It consists of seven questions that cover various aspects of asthma symptoms and their impact on daily life. To calculate the ACQ score, sum the points from all questions (1-7) and divide by 7. If question 7 is not available, sum by 6.
Time frame: Interventions lasting 12 weeks
The Simplified Chinese version of the 10-item Perceived Stress Scale (SCPSS-10) has been used to measure and evaluate perceived stress in various populations. This scale allows researchers to assess stress levels effectively among Chinese-speaking individuals. See Huang, F. et al, 2020. Psychometric properties of the perceived stress scale in a community sample of Chinese. BMC psychiatry, 20, pp.1-7.
Time frame: Measured throughout the 12 weeks of intervention
Feasibility in terms of attendance rate for training sessions is often assessed by setting a benchmark, such as achieving over 50% attendance. Higher attendance rates generally indicate greater feasibility and engagement with the training program. Low attendance can suggest issues with the program's design or relevance, especially in unsupervised training interventions, which tend to have lower attendance and effectiveness.
Time frame: Interventions lasting 12 weeks
Measured by a grip strength tester (for individuals aged 10-80), the average grip strength is approximately 37.2 kg for the right hand and 34.7 kg for the left hand.
Yufen Wu, MD
Other
Intervention Effects of High-intensity Tai Chi in Mild or Moderate Asthma: a Preliminary Feasibility and Randomized Controlled Study
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