Supine Daoyin in the Treatment of AECOPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Supine Daoyin
western medicine conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic obstructive pulmonary disease, Acute exacerbation, Pulmonary rehabilitation, Supine Daoyin, Randomized controlled trail
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Henan University of ChineseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Supine Daoyin
Control
Arm Description
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.
The control group will get the western medicine conventional therapy with some additional tests for the study.
Outcomes
Primary Outcome Measures
Length of hospital stay due to acute exacerbation
The time from hospitalization to discharge was counted
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.
Secondary Outcome Measures
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.
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.
30-second sit-to-stand test
Record the times of sitting and standing test within 30 seconds
Mechanical ventilation
The number of patients using noninvasive or invasive mechanical ventilation during the study period was counted
6 Minutes Walking Distance Test (6MWD)
The 6-minute walking distance of the two groups was calculated
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.
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.
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.
Full Information
NCT ID
NCT04913961
First Posted
April 26, 2021
Last Updated
January 3, 2022
Sponsor
Henan University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04913961
Brief Title
Supine Daoyin in the Treatment of AECOPD
Official Title
Efficacy Evaluation of Supine Daoyin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multi-center, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic obstructive pulmonary disease, Acute exacerbation, Pulmonary rehabilitation, Supine Daoyin, Randomized controlled trail
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supine Daoyin
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will get the western medicine conventional therapy with some additional tests for the study.
Intervention Type
Other
Intervention Name(s)
Supine Daoyin
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
western medicine conventional therapy
Intervention Description
The control group will get the western medicine conventional therapy with some additional tests for the study.
Primary Outcome Measure Information:
Title
Length of hospital stay due to acute exacerbation
Description
The time from hospitalization to discharge was counted
Time Frame
through study completion, an average of 2 weeks
Title
Clinical symptom assessment questionnaire (CCQ)
Description
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.
Time Frame
Change from baseline CCQ scores at day 3,day 7,day 14
Secondary Outcome Measure Information:
Title
Activities of daily living (Barthel index)
Description
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.
Time Frame
Change from baseline Barthel index scores at day 3,day 7,day 14
Title
Borg dyspnea score
Description
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.
Time Frame
Change from baseline Borg dyspnea score at day 3,day 7,day 14
Title
30-second sit-to-stand test
Description
Record the times of sitting and standing test within 30 seconds
Time Frame
Change from baseline 30-second sit-to-stand test at day 3,day 7,day 14
Title
Mechanical ventilation
Description
The number of patients using noninvasive or invasive mechanical ventilation during the study period was counted
Time Frame
through study completion, an average of 2 weeks
Title
6 Minutes Walking Distance Test (6MWD)
Description
The 6-minute walking distance of the two groups was calculated
Time Frame
Change from baseline 6MWD test at day 7,day 14
Title
St. George's Respiratory Questionnaire(SGRQ)
Description
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.
Time Frame
Change from baseline SGRQ scores at day 3,day 7,day 14
Title
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
Description
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.
Time Frame
Change from baseline mPRO-COPD scores at day 3,day 7,day 14
Title
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
Description
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.
Time Frame
Change from baseline mESQ-COPD scores at day 3,day 7,day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang hailong, doctor
Phone
+86 371 66248624
Email
zhanghailong6@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li jiansheng, doctor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li jiansheng, doctor
Organizational Affiliation
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Henan University of Chinese
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jiansheng Li, doctor
Phone
+86 371 66248624
Email
li-js8@163.com
First Name & Middle Initial & Last Name & Degree
hailong zhang, doctor
Phone
+86 371 66248624
Email
13643718969@163.com
12. IPD Sharing Statement
Learn more about this trial
Supine Daoyin in the Treatment of AECOPD
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