Intervention Effects of High-intensity Tai Chi in Mild or Moderate Asthma: a Preliminary Feasibility and Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Forced expiratory volume in 1 second (FEV1), the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
研究概览
简要总结
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:
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old;
- •Diagnosis of mild to moderate asthma for at least 6 months (meeting the lung capacity measurement criteria for mild to moderate asthma);
- •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).
排除标准
- •Other lung diseases;
- •Only experiencing exercise-induced asthma (asthma is only triggered by exercise and there are no asthma symptoms in other situations;
- •Due to chronic illness requiring oral hormone therapy in the past month;
- •Physical condition prohibits any exercise;
- •recently unstable medical conditions.
- •All ethnic groups and genders are eligible to participate in this study.
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1), the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration
时间窗: Interventions lasting 12 weeks
An FEV1 of less than 1 Liter indicates significant lung disease.
Peak Expiratory Flow (PEF): a person's maximum speed of expiration, measuring the airflow through the bronchi (measured in units of liters per minute)
时间窗: 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.
Asthma Control Questionnaire 7 (ACQ-7) score
时间窗: 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.
Perceived Stress: measured by the simplified Chinese version of the 10-item Perceived Stress Scale (SCPSS-10)
时间窗: 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.
Feasibility (measured by attendance rate of the training sessions)
时间窗: 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.
次要结局
- Grip strength by kilograms(Interventions lasting 12 weeks)
研究者
Yufen Wu, MD
physician-in-charge
Shanghai Jiao Tong University School of Medicine