Baduanjin Exercise for Patients With GOLD 2-3 Stable COPD on Pulmonary Rehabilitation

Study Overview
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Brief Summary
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Chronic Obstructive Pulmonary Disease (COPD) is a disease with a very high morbidity and mortality rate. When the lung function drops lower and lower, patients will bear great affliction physically and mentally. How to improve the quality of life in patients with COPD is a hot topic in the study of COPD now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for COPD patients.

Detailed Description
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To investigate the efficacy of Baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase II III. A prospective, randomized, controlled clinical trial was designed.

Official Title
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Baduanjin Exercise for Patients With GOLD 2-3 Stable Chronic Obstructive Pulmonary Disease on Pulmonary Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Baduanjin exercise
* Device: Instrument rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 40 to 80 years Diagnosed with stable chronic obstructive pulmonary disease Phase II III Exclusion Criteria: The condition was serious or movement restrained by other diseases In the acute exacerbation of chronic obstructive pulmonary disease Participants who have contraindications to exercise training Patients who have other serious acute, chronic organic disease or mental disorders

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin exercise group<br>Participants in this group received Baduanjin exercise | Behavioral: Baduanjin exercise<br>* Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks<br>|
| Active Comparator: Instrument rehabilitation group<br>Participants in this group received rehabilitation by using tri-ball respiratory trainer | Device: Instrument rehabilitation<br>* Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks<br>|
| Active Comparator: Baduanjin Exercise and Instrument Rehabilitation<br>Participants in this group received both instrument rehabilitation and Baduanjin exercise | Behavioral: Baduanjin exercise<br>* Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks<br>Device: Instrument rehabilitation<br>* Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks<br>|
| No Intervention: No Intervention<br>Participants in this group only received routine drug-treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. George's respiratory questionnaire (SGRQ) | Evaluating the changes of impact on quality of life | Baseline, 3 months, 6 months | 
| Six-minute walk test (6MWT) | Testing patients changes on walking distance and accompanies symptoms in 6 minutes | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmanory function indicators (FEV1/FVC, FEV1pred%) | Assessing changes of airway limitation | Baseline, 3 months, 6 months | 
| Modified British medical research council questionnaire (mMRC) | Evaluating the severity of dyspnea, totally has 5 grade from 0-4, the higher grade represent a severer symptom | Baseline, 1 month, 2 months, 3 months, 6 months | 
| COPD assessment test (CAT) | Assessing the quality of life, the total score ranges from 0-40, the higher score represent a worse outcome | Baseline, 1 month, 2 months, 3 months, 6 months | 
| Times of acute exacerbation | Recording the frequency of acute exacerbation | Baseline, 1 month, 2 months, 3 months, 6 months | 
| Self-rating anxiety scale (SAS) | Evaluating the stage of anxiety, the total score ranges from 20-80, the higher score represent a worse outcome | Baseline, 3 months, 6 months | 
| Self-rating depression scale (SDS) | Evaluating the stage of depression, the total score ranges from 20-80, the higher score represent a worse outcome | Baseline, 3 months, 6 months |