Intervention Effects of High-intensity Tai Chi in Mild or Moderate Asthma

NCT06728904 | Enrolling By Invitation

• 1 other identifier: wuyufen2007
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• Forced expiratory volume in 1 second (FEV1), the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration

  An FEV1 of less than 1 Liter indicates significant lung disease.

  Interventions lasting 12 weeks

• Peak Expiratory Flow (PEF): a person's maximum speed of expiration, measuring the airflow through the bronchi (measured in units of liters per minute)

  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.

  Interventions lasting 12 weeks

• Asthma Control Questionnaire 7 (ACQ-7) score

  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.

  Interventions lasting 12 weeks

• Perceived Stress: measured by the simplified Chinese version of the 10-item Perceived Stress Scale (SCPSS-10)

  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.

  Interventions lasting 12 weeks

• Feasibility (measured by attendance rate of the training sessions)

  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.

  Measured throughout the 12 weeks of intervention

Secondary Outcomes (1)

• Grip strength by kilograms

  Interventions lasting 12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

The experimental group needs to complete high-intensity Tai Chi intervention for about 4-8 weeks according to the intervention requirements, 3-5 times/week, 45-90 minutes/time. Except for this, participants are required to participate in theoretical knowledge learning such as health lectures and online courses, as well as home autonomy exercises. This study will monitor the training status of participants through enterprise WeChat, mini programs, or app check-in to ensure high compliance. In addition, as the research subjects belong to a special population, this study expects to use the Subjective Fatigue Scale (RPE) to monitor the fatigue level of the subjects in real time to ensure safety.

Behavioral: Tai Chi intervention

control group

NO INTERVENTION

This study provides health education and stretching courses for the control group. Various health education professionals will provide educational courses on asthma treatment topics, covering self-assessment, coping strategies, solutions, dietary nutrition, and disease management. At the same time, the participants in this group are required to participate in stretching courses (such as 40 minutes/time, 3 times/week), as well as home self stretching (expected to be 20 minutes/day).

Interventions

Tai Chi intervention BEHAVIORAL

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• Other lung diseases;
• Only experiencing exercise-induced asthma (asthma is only triggered by exercise and there are no asthma symptoms in other situations;
• pregnancy;
• 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.

Sponsors & Collaborators

• Yufen Wu, MD: lead

Study Sites (1)

Shanghai University of Finance and Economics

Shanghai, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yufen Wu, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician-in-charge

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 11, 2024
• Study Start: December 10, 2024
• Primary Completion: July 20, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)