A Randomized Controlled Trial of an Intelligent Pulmonary Function Exercise Device Versus Usual Care for In-Hospital and Home-Based Pulmonary Rehabilitation After Lung Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
This study will compare an intelligent pulmonary function exercise device with usual care and natural recovery in patients recovering from lung cancer surgery.
After lung cancer surgery, many patients have reduced lung function, shortness of breath, lower exercise tolerance, and a risk of postoperative pulmonary complications. Standard care usually includes postoperative nursing, pain control, coughing and sputum clearance instruction, early mobilization, discharge education, and routine follow-up. However, patients often lack structured guidance, feedback, and monitoring after discharge.
Participants in this study will be randomly assigned to one of two groups. One group will use an intelligent pulmonary function exercise device for respiratory training during hospitalization and at home until 30 days after surgery. The prescribed training is two sessions per day, with each session including 30 expiratory training repetitions and 30 inspiratory training repetitions. The device records training completion and related training information and provides reminders and feedback. The other group will receive usual perioperative care, standard discharge education, and natural recovery follow-up without a study-specified respiratory training device or training prescription.
The main purpose of the study is to determine whether the intelligent pulmonary function exercise device improves recovery of forced expiratory volume in 1 second, or FEV1, from before surgery to 30 days after surgery. The study will also evaluate lung function at 90 days, symptoms, quality of life, walking capacity, training adherence, and postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 18 to 75 years.
- •Pathologically confirmed primary non-small cell lung cancer.
- •Scheduled to undergo elective thoracoscopic lobectomy or sublobar resection.
- •Able to understand the study and voluntarily sign written informed consent before surgery.
- •5. Able to communicate and complete study assessments and postoperative follow-up.
- •6. Able to use a smartphone independently or with assistance from a caregiver for training records.
- •7. Good lung re-expansion on postoperative chest imaging.
- •No chest tube drainage or no persistent air leak from chest tube drainage.
- •Clinical stage cT1-T2b, N0-N1, M0, stage IA-IIB.
- •Home environment allows safe training.
排除标准
- •1. Preoperative measured FEV1 less than 50% of predicted value.
- •Severe cardiopulmonary dysfunction or other conditions judged unsuitable for respiratory training.
- •3. Previous thoracic surgery or major thoracic trauma.
- •Significant cognitive impairment or psychiatric disorder that prevents cooperation with the study.
- •5. Pregnancy or breastfeeding.
- •Recent severe infection or active pulmonary disease.
研究者
Jianxing He
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University