Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Six-minute walk distance (6MWD)
研究概览
简要总结
The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population.
详细描述
Background: Elderly patients with compromised lung function or poor health conditions undergoing lung resection surgery face an increased risk of postoperative pulmonary complications. Pulmonary rehabilitation programs play a crucial role in enhancing recovery after surgery, having been shown to reduce postoperative pulmonary complications and enhance patients' pre- and post-operative exercise capacity, functional performance, and quality of life. However, due to the heterogeneity of interventions in pulmonary rehabilitation programs, the optimal timing, methods, or duration of exercise training for lung resection patients remain unclear. Additionally, there is a lack of comprehensive research on the changes and impacts of biomarkers in the blood of lung resection patients following intervention with pulmonary rehabilitation programs.
Objectives: This study aims to investigate the physiological and biological effects of a comprehensive pulmonary rehabilitation program in lung resection surgery patients with limited exercise capacity and impaired lung function.
Research Methods: This study adopts an open label, randomized, parallel design, intending to recruit 96 lung resection surgery participants divided into a control group receiving standard care and an experimental group receiving the comprehensive pulmonary rehabilitation programs. The intervention period spans 1-2 weeks pre-surgery, during hospitalization, and 3-6 weeks post-discharge. Participants will undergo four assessments at randomization (baseline, T0), one day pre-surgery (T1), the day of discharge post-surgery (T2), and at trial completion (T3). The primary endpoint is the six-minute walk test. Secondary endpoints include lung function, lung expansion volume, respiratory muscle strength, incidence of postoperative complications and pulmonary complications, chest tube duration, length of hospital stay, quality of life (EORTC QLQ-C30), and pain. Exploratory endpoints involve inflammation-related and immune-related biomarkers.
Expected Impact: This study will provide valuable insights into the physiological and biological effects of a comprehensive pulmonary rehabilitation programs for lung resection surgery patients. Results may contribute to improving patient outcomes and advancing academic understanding and clinical guidelines in this field.
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
盲法说明
The blinding of patients to their treatment group allocation is unattainable owing to the inherent nature of the exercise intervention.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥ 20 years old)
- •Receiving lung resection surgery
- •At least one of the following:
- •6MWD < 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2< 90% during 6MWT, pre-operative forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7
- •Able to walk autonomously without mobility aids
- •Written informed consent
排除标准
- •Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery
- •Received pulmonary rehabilitation programs six months prior to surgery
- •Previous lung resection
- •Inability to perform the exercise training
- •Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions
- •Have cognitive deficits with potential severe impact on compliance
- •Do not provide written informed consent
结局指标
主要结局
Six-minute walk distance (6MWD)
时间窗: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
Six-minute walk test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance.
次要结局
- Length of hospital stay (LoS)(an average of post-surgery 2 weeks)
- Duration of chest-tube insertion(an average of post-surgery 2 weeks)
- Numerical Rating Scale (NRS)(Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan))(Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks)
- Pulmonary function test(Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks)
- Respiratory muscle strength(Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks)
- Postoperative complications (POCs) and postoperative pulmonary complications (PPCs)(an average of post-surgery 2 weeks)
- Lung expansion volume(Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks)