TCM Daoyin Therapy in Individuals At-risk for COPD

NCT05940480 | Active Not Recruiting

• 1 other identifier: ZY(2021-2023)- 0105-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Lung Diseases, Obstructive

Keywords

TCM Daoyin; at-risk for COPD; early COPD; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Lung function

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

  Change from Baseline lung function at 16 weeks

Secondary Outcomes (6)

• 6-min walk distance(6MWD)

  Change from Baseline 6MWD at 16 weeks

• Immune function

  Change from Baseline immune function at 16 weeks

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

  Change from Baseline DASS-21 at 16 weeks

• St. George's Respiratory Questionnaire (SGRQ)

  Change from Baseline SGRQ at 16 weeks

• Adverse effects

  8 weeks

Study Arms (2)

TCM Daoyin intervention group

EXPERIMENTAL

Participants randomized to TCM Daoyin intervention group receive health education plus a TCM Daoyin training program. The TCM Daoyin training program was a 16-week, instructor-led group training program.

Behavioral: TCM Daoyin; Behavioral: Health education

Health education control group

ACTIVE COMPARATOR

Participants randomized to the health education control group only receive health education and no additional training program.

Behavioral: Health education

Interventions

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.

Also known as: Qigong

TCM Daoyin intervention group

Health education BEHAVIORAL

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

Health education control group; TCM Daoyin intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Changzheng Community Health Service Center of Putuo District, Shanghai: collaborator

Study Sites (2)

Shanghai Qigong Research Institute

Shanghai, Shanghai Municipality, 021, China

Location

Changzheng Community Health Service Center of Putuo District, Shanghai

Shanghai, Shanghai Municipality, 200333, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Qigong

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Xiaoting Zhao

  Shanghai Qigong Research Institute

  STUDY CHAIR

• Jie Li, Doctor

  Shanghai University of Traditional Chinese Medicine

  STUDY DIRECTOR

• Ying Lu, Master

  Shanghai Qigong Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors were blinded to the group allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant researcher

Model Details: This study is a 16-week, randomized controlled trial. Individuals at-risk for COPD are randomized to either TCM Daoyin intervention group or health education control group.

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)