Supine Daoyin in the Treatment of AECOPD

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.

Detailed Description
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Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease with high incidence rate, high mortality rate and high disability rate. Among the people over 40, the prevalence rate is 10.1%, while the prevalence rate in China is 13.7%. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major event that affects the natural course of COPD. In particular, most patients with AECOPD have poor prognosis, higher morbidity and mortality, and lower quality of life. Pulmonary rehabilitation can improve the clinical symptoms of AECOPD patients, increase exercise tolerance, delay the decline of lung function, and improve the quality of life. In recent years, the clinical research on the rehabilitation of patients with AECOPD is still in the exploratory stage, which needs to be supported by clear evidence. This is a multicenter, randomized controlled trial to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD. After admission, the patients were randomly divided into two groups, rehabilitation group and control group, 114 cases in each group. After routine treatment, the patients began to recover when they reached the initial rehabilitation standard, and recovered until they reached the discharge standard. The primary outcomes are the length of hospital stay due to acute exacerbation and clinical symptom score. The secondary outcomes include activities of daily living, dyspnea score, 6-minute walking distance, lower limb muscle strength, mechanical ventilation and quality of life. Safety will also be assessed.

Official Title
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Efficacy Evaluation of Supine Daoyin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multi-center, Randomized Controlled Trial

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Supine Daoyin
* Other: western medicine conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed diagnosis of AECOPD. Age between 40 and 80 years. mMRC score ≥ 3. Barthel index<50. With the informed consent signed. Exclusion Criteria: Patients with severe cognitive impairment, dementia and various psychosis. Combined with severe arthritis and other osteoarthritis affecting the movement. Dyskinesia due to neuromuscular diseases. Long term bedridden for various reasons. Participating in other trials.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supine Daoyin<br>During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study. | Other: Supine Daoyin<br>* During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study<br>|
| Active Comparator: Control<br>The control group will get the western medicine conventional therapy with some additional tests for the study. | Other: western medicine conventional therapy<br>* The control group will get the western medicine conventional therapy with some additional tests for the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay due to acute exacerbation | The time from hospitalization to discharge was counted | through study completion, an average of 2 weeks | 
| Clinical symptom assessment questionnaire (CCQ) | The Clinical symptom assessment questionnaire (CCQ) is a self-administered questionnaire that measures health-related quality of life. It is an 10-item questionnaire on a 0-6 point scale with higher values indicating greater impact of COPD. | Change from baseline CCQ scores at day 3，day 7，day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living (Barthel index) | Activities of daily living (ADL): the scale includes 10 items, including 8 items of self-care activities and 2 items of action related activities, with a total score of 100. | Change from baseline Barthel index scores at day 3，day 7，day 14 | 
| Borg dyspnea score | Borg dyspnea score is is a 10-point (0-10) scale based on the severity of dyspnoea. 0 means no dyspnea perception, 10 means most severe dyspnea perception. | Change from baseline Borg dyspnea score at day 3，day 7，day 14 | 
| 30-second sit-to-stand test | Record the times of sitting and standing test within 30 seconds | Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14 | 
| Mechanical ventilation | The number of patients using noninvasive or invasive mechanical ventilation during the study period was counted | through study completion, an average of 2 weeks | 
| 6 Minutes Walking Distance Test (6MWD) | The 6-minute walking distance of the two groups was calculated | Change from baseline 6MWD test at day 7，day 14 | 
| St. George's Respiratory Questionnaire（SGRQ） | The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes. | Change from baseline SGRQ scores at day 3，day 7，day 14 | 
| The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) | The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status. | Change from baseline mPRO-COPD scores at day 3，day 7，day 14 | 
| The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) | The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction. | Change from baseline mESQ-COPD scores at day 3，day 7，day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Acute exacerbation, Pulmonary rehabilitation, Supine Daoyin, Randomized controlled trail