Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance: A Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 548
- 试验地点
- 1
- 主要终点
- 6 Minutes Walking Distance Test (6MWD)
研究概览
简要总结
This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.
详细描述
Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease in China. Based on the digital management platform, 548 patients with COPD in stable stage were selected as the research objects. A multi-center, randomized, controlled clinical trial design was adopted to scientifically evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability and reveal its mechanism of action. A breath-guided rehabilitation program based on intelligent iot and remote home was established and promoted to improve exercise ability and reduce acute exacerbation. To form high-quality clinical evidence, and realize tracking management, real-time evaluation and effect evaluation throughout rehabilitation.
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
- •Patients with COPD in stable stage
- •Patients with grade 2 to 4 lung function
- •Age 40~80 years old
- •Be able to use smart phones, computers and other devices independently or with the help of family members during home training
- •Volunteer for treatment and sign an informed consent form
排除标准
- •Pregnant or lactating women and patients with recent pregnancy plans
- •Delirious, dementia, all kinds of mental illness
- •Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years
- •Patients with severe osteoarthropathy or osteoporosis, unstable fractures
- •Patients with severe visual impairment that cannot be improved or who have epilepsy or vertigo and cannot use VR devices
- •Patients with progressive neuromuscular disease
- •Patients with pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism and other pulmonary diseases
- •Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.)
- •Patients with severe liver disease (cirrhosis, portal hypertension and bleeding caused by esophageal and gastric varices, etc.) and severe kidney disease (dialysis, kidney transplantation, etc.)
- •Participants who were participating in other clinical trials within 1 month prior to enrollment
- •People who stay in bed for a long time for various reasons
研究组 & 干预措施
Breathing guided rehabilitation group
The breathing guided rehabilitation group will receive conventional western medicine treatment and breathing guided exercise which consists of training and patient education. They will be evaluated with some tests for the study.
干预措施: Breathing guided exercise (Behavioral)
Flat ground walking training
The flat ground walking training group will receive conventional western medicine treatment and flat walking training which consists of training and patient education. They will be evaluated with some tests for the study.
干预措施: Flat walking training (Behavioral)
结局指标
主要结局
6 Minutes Walking Distance Test (6MWD)
时间窗: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The 6-minute walking distance of the two groups was calculated
次要结局
- Incidence of acute exacerbation(Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- Degree of breathing difficulty(Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- Borg dyspnea score(Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- The COPD Assessment Test(CAT)(Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- Lung function(Changes in baseline Lung function test at weeks 0 and 24 of the treatment.)
- Anxiety Scale(Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- Depression Scale(Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- Clinical symptom assessment questionnaire (CCQ)(Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- St. George's Respiratory Questionnaire (SGRQ)(Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)(Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)
- The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)(Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.)