TCM Daoyin Therapy in Individuals At-risk for COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Lung Diseases, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessors were blinded to the group allocation of the participants.

Study Groups

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TCM Daoyin intervention group

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.

Group Type EXPERIMENTAL

TCM Daoyin

Intervention Type 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.

Health education

Intervention Type BEHAVIORAL

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

Health education control group

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

Group Type ACTIVE_COMPARATOR

Health education

Intervention Type BEHAVIORAL

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

Interventions

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TCM Daoyin

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.

Intervention Type BEHAVIORAL

Health education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Qigong

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No