Efficacy Evaluation of Supine Daoyin in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Length of hospital stay due to acute exacerbation
研究概览
简要总结
The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of AECOPD.
- •Age between 40 and 80 years.
- •mMRC score ≥
- •Barthel index<
- •With the informed consent signed.
排除标准
- •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.
结局指标
主要结局
Length of hospital stay due to acute exacerbation
时间窗: through study completion, an average of 2 weeks
The time from hospitalization to discharge was counted
Clinical symptom assessment questionnaire (CCQ)
时间窗: 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.
次要结局
- St. George's Respiratory Questionnaire（SGRQ）(Change from baseline SGRQ scores at day 3，day 7，day 14)
- Activities of daily living (Barthel index)(Change from baseline Barthel index scores at day 3，day 7，day 14)
- Borg dyspnea score(Change from baseline Borg dyspnea score at day 3，day 7，day 14)
- 6 Minutes Walking Distance Test (6MWD)(Change from baseline 6MWD test at day 7，day 14)
- 30-second sit-to-stand test(Change from baseline 30-second sit-to-stand test at day 3，day 7，day 14)
- Mechanical ventilation(through study completion, an average of 2 weeks)
- The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)(Change from baseline mPRO-COPD scores at day 3，day 7，day 14)
- The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)(Change from baseline mESQ-COPD scores at day 3，day 7，day 14)