Chronic Obstructive Pulmonary DiseaseNCT04913961
Supine Daoyin in the Treatment of AECOPD
A study testing Supine Daoyin and western medicine conventional therapy in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Supine Daoyin and western medicine conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of AECOPD.
- Age between 40 and 80 years.
- mMRC score ≥ 3.
- Barthel index<50.
- With the informed consent signed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Li jiansheng, doctor contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Chinese
Zhengzhou, Henan, 450003
jiansheng Li, doctor, +86 371 66248624, li-js8@163.com
hailong zhang, doctor, +86 371 66248624, 13643718969@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Supine Daoyin, western medicine conventional therapy
- Keywords
- Chronic obstructive pulmonary disease, Acute exacerbation, Pulmonary rehabilitation, Supine Daoyin, Randomized controlled trail
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine DaoyinOther
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 therapyOther
The control group will get the western medicine conventional therapy with some additional tests for the study.
| Study group | Role | What they receive |
|---|---|---|
| Supine Daoyin | Experimental | 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. Receives: Other: Supine Daoyin |
| Control | Active comparator | The control group will get the western medicine conventional therapy with some additional tests for the study. Receives: Other: western medicine conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay due to acute exacerbation
The time from hospitalization to discharge was counted
Measured: 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.
Measured: Change from baseline CCQ scores at day 3，day 7，day 14
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline mESQ-COPD scores at day 3，day 7，day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li jiansheng, doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913961
- Sponsor's protocol ID
- Daoyin for AECOPD
- Status last verified
- Jan 2022
- First submitted
- 26 Apr 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Supine Daoyin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04913961
- Acronym / sponsor ID
- Daoyin for AECOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Acute exacerbation, Pulmonary rehabilitation, Supine Daoyin, Randomized controlled trail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine Daoyin | Experimental | Other: Supine DaoyinDuring 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. |
| Control | Active comparator | Other: western medicine conventional therapyThe control group will get the western medicine conventional therapy with some additional tests for the study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of AECOPD.
- Age between 40 and 80 years.
- mMRC score ≥ 3.
- Barthel index<50.
- With the informed consent signed.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine DaoyinDuring 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 |
| western medicine conventional therapyThe control group will get the western medicine conventional therapy with some additional tests for the study. | Other | Control |
Primary outcome
Length of hospital stay due to acute exacerbation
Time frame: through study completion, an average of 2 weeks
The time from hospitalization to discharge was counted
Clinical symptom assessment questionnaire (CCQ)
Time frame: Change from baseline CCQ scores at day 3，day 7，day 14
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.
8 secondary outcomes
Activities of daily living (Barthel index)
Time frame: Change from baseline Barthel index scores at day 3，day 7，day 14
Borg dyspnea score
Time frame: Change from baseline Borg dyspnea score at day 3，day 7，day 14
30-second sit-to-stand test
Time frame: Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14
Mechanical ventilation
Time frame: through study completion, an average of 2 weeks
6 Minutes Walking Distance Test (6MWD)
Time frame: Change from baseline 6MWD test at day 7，day 14
St. George's Respiratory Questionnaire（SGRQ）
Time frame: Change from baseline SGRQ scores at day 3，day 7，day 14
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
Time frame: Change from baseline mPRO-COPD scores at day 3，day 7，day 14
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
Time frame: Change from baseline mESQ-COPD scores at day 3，day 7，day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li jiansheng, doctor contact
Li jiansheng, doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine Daoyin and western medicine conventional therapy in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang hailong, doctor (+86 371 66248624, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay due to acute exacerbation (time frame: through study completion, an average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.