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Active, Not Recruiting

NCT Number: NCT05940480

TCM Daoyin Therapy in Individuals At-risk for COPD

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on Individuals at-risk for COPD.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changzheng Community Health Service Center of Putuo District, Shanghai, Shanghai, Shanghai Municipality, China

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About this study

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide. Early prevention and treatment of COPD is crucial, but there is a lack of specific interventions for individuals at-risk for COPD in clinical guidelines. The study focuses on individuals at-risk for COPD (COPD-SQ≥16, current lung function failed to meet diagnostic criteria for COPD but with manifestations of early airflow limitation).

This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 60 participants (30 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 30 for health education control group only receiving health education).

TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous researches have provided some evidence of beneficial effects on TCM Daoyin for COPD patients with an established diagnosis, such as Liuzijue and Baduanjin. However, the evidences of TCM Daoyin on patients with early COPD is limited. The aim of prospective randomized study is to evaluate the effects of TCM Daoyin training on individuals at-risk of COPD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject at-risk for COPD (Chronic obstructive pulmonary disease screening questionnaire (COPD-SQ) score≥16; and pre-bronchodilator FEV1/FVC ≥ 0.70, or pre-bronchodilator FEV1/FVC<0.70 but post-bronchodilator FEV1/FVC ≥ 0.70).
  • Aged 40 to 75, male or female.
  • Subject has a clear mind and the ability to lead an independent life.
  • Subject agrees to perform a blood-test.
  • Subject agrees to participate in this study and sign to the informed consent.

Exclusion criteria

  • Subject with acute exacerbation of COPD.
  • Subject with respiratory infectious disease (e.g., tuberculosis, influenza, etc.) within 1 month.
  • Subject with serious current unstable physical illness and mental illness.
  • Subject with definite clinical diagnosis of Alzheimer's disease, or severe cognitive impairment.
  • Subject is pregnant or lactating women.

Treatment and study plan

TCM Daoyin

Behavioral

The TCM Daoyin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown.

Other names: Qigong

Health Education

Behavioral

Health education is provided by doctor and nurse, including work, rest, diet and other basic programs.

Primary outcomes

  1. Lung function

    Time frame: Change from Baseline lung function at 16 weeks

    Participants' lung function (FVC、FVC%、FEV1、FEV1%、FEV1/FVC) will be tested to identify air flow condition in both group.

Secondary outcomes

  1. 6-min walk distance(6MWD)

    Time frame: Change from Baseline 6MWD at 16 weeks

    The 6MWD is a well-established field exercise test to assess the functional exercise capacity in COPD clinical trials.

  2. Immune function

    Time frame: Change from Baseline immune function at 16 weeks

    Venous blood will be collect to detect immunity function (IL-6, IL-8, IL-10 and biomarkers).

  3. Depression, Anxiety and Stress Scale-21 item (DASS-21)

    Time frame: Change from Baseline DASS-21 at 16 weeks

    Questions focus on depressive, anxious and stress symptoms during the past 7 days, and higher cumulative scores indicate more severe depression, anxiety and stress. Subscale scores are calculated as the sum of the responses to the seven items from each subscale multiplied by 2. The cutoffs for depression, anxiety, and stress are >9, >7, and >14, respectively.

  4. St. George's Respiratory Questionnaire (SGRQ)

    Time frame: Change from Baseline SGRQ at 16 weeks

    Quality of Life will be assessed by St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a disease-specific measure of health status for use in COPD. It has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling worse). A 4-unit change is the minimum clinically important difference.

  5. Adverse effects

    Time frame: 8 weeks

    During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.

  6. Adverse effects

    Time frame: 16 weeks

    During the intervention period, the doctors will ask specifically about, and record any adverse effect of the treatment that may have occurred.

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Changzheng Community Health Service Center of Putuo District, Shanghai

Registry information

Official study title

TCM Daoyin Therapy in Early Chronic Obstructive Pulmonary Disease: A Pilot Study

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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