Supine Daoyin in the Treatment of AECOPD

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Supine Daoyin; Other: western medicine conventional therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang hailong, doctor; Phone Number: +86 371 66248624; Email: zhanghailong6@126.com
• Study Contact Backup: Name: Li jiansheng, doctor

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • The First Affiliated Hospital of Henan University of Chinese
      • Contact: jiansheng Li, doctor; Phone Number: +86 371 66248624; Email: li-js8@163.com
      • Contact: hailong zhang, doctor; Phone Number: +86 371 66248624; Email: 13643718969@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Control; The control group will get the western medicine conventional therapy with some additional tests for the study.	Other: western medicine conventional therapy; The control group will get the western medicine conventional therapy with some additional tests for the study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Investigators: Study Chair: Li jiansheng, doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Pulmonary rehabilitation; Acute exacerbation; Randomized controlled trail; Supine Daoyin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Daoyin for AECOPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No