Supine Daoyin in the Treatment of AECOPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913961
• Other study ID #: Daoyin for AECOPD
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Henan University of Traditional Chinese Medicine
• Contact: Zhang hailong, doctor
• Phone: +86 371 66248624
• Email: zhanghailong6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. A confirmed diagnosis of AECOPD.

2. Age between 40 and 80 years.

3. mMRC score = 3.

4. Barthel index<50.

5. With the informed consent signed.

Exclusion Criteria:

1. Patients with severe cognitive impairment, dementia and various psychosis.

2. Combined with severe arthritis and other osteoarthritis affecting the movement.

3. Dyskinesia due to neuromuscular diseases.

4. Long term bedridden for various reasons.

5. Participating in other trials.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Supine Daoyin
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
• western medicine conventional therapy
The control group will get the western medicine conventional therapy with some additional tests for the study.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Chinese	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay due to acute exacerbation	The time from hospitalization to discharge was counted	through study completion, an average of 2 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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