Clinical trial NCT04913961: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
Acute exacerbation
Pulmonary rehabilitation
Supine Daoyin
Randomized controlled trail
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 228
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay due to acute exacerbation
timeFrame: through study completion, an average of 2 weeks
measure: Clinical symptom assessment questionnaire (CCQ)
timeFrame: Change from baseline CCQ scores at day 3，day 7，day 14
Secondary outcomes:
measure: Activities of daily living (Barthel index)
timeFrame: Change from baseline Barthel index scores at day 3，day 7，day 14
measure: Borg dyspnea score
timeFrame: Change from baseline Borg dyspnea score at day 3，day 7，day 14
measure: 30-second sit-to-stand test
timeFrame: Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14
measure: Mechanical ventilation
timeFrame: through study completion, an average of 2 weeks
measure: 6 Minutes Walking Distance Test (6MWD)
timeFrame: Change from baseline 6MWD test at day 7，day 14
measure: St. George's Respiratory Questionnaire（SGRQ）
timeFrame: Change from baseline SGRQ scores at day 3，day 7，day 14
measure: The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
timeFrame: Change from baseline mPRO-COPD scores at day 3，day 7，day 14
measure: The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
timeFrame: Change from baseline mESQ-COPD scores at day 3，day 7，day 14
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Chinese
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Li jiansheng, doctor
role: STUDY_CHAIR
References: