Department of Rehabilitation Medicine and Institute of Rehabilitation Medicine, Sichuan University West China Hospital, Chengdu, Sichuan, China.
Key Laboratory of Rehabilitation Medicine in Sichuan Province, Sichuan University West China Hospital, Chengdu, Sichuan, China.
BMJ Open. 2023 May 8;13(5):e067845. doi: 10.1136/bmjopen-2022-067845.
INTRODUCTION: Lung cancer remains a highly fatal disease. Surgical resection has been proven to be the most effective treatment for early-stage lung cancer. The conventional hospital-based pulmonary rehabilitation (PR) is shown to reduce symptoms, improve exercise capacity and impact the quality of life (QoL) for lung cancer patients. To date, scientific evidence on the effectiveness of home-based PR for patients with lung cancer following surgery is scarce. We aim to explore if home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection. METHODS AND ANALYSIS: This study is a two-arm, parallel-group, assessor-blind, single-centre, randomised controlled trial. Participants will be recruited from West China Hospital, Sichuan University and randomly allocated to either an outpatient group or a home-based group at a ratio of 1:1. The PR programme involves self-management and exercises. The exercise includes warm-up (10 min), aerobic training (20 min), resistance training (15 min) and cool-down (10 min), lasting 4 weeks, with two sessions per week either at home or in the outpatient setting. The intensity will be adjusted according to the modified Borg rating of perceived exertion and heart rate before and after each exercise session. The primary outcome is QoL measured by EORTC QLQ-C30 & LC 13 after an intervention. Secondary outcomes include physical fitness measured by a 6 min walk test and stair-climbing test and symptom severity measured by patient-reported questionnaires and pulmonary function. The main hypothesis is that home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection. ETHICS AND DISSEMINATION: The trial has been approved by the Ethical Committee of West China Hospital and is also registered with the Chinese Clinical Trial Registry. The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2100053714.
简介：肺癌仍然是一种高度致命的疾病。手术切除已被证明是治疗早期肺癌最有效的方法。常规的基于医院的肺康复（PR）已被证明可以减轻症状、提高运动能力并影响肺癌患者的生活质量（QoL）。迄今为止，关于手术后肺癌患者进行基于家庭的 PR 的有效性的科学证据仍然有限。我们旨在探讨基于家庭的 PR 是否与手术后肺癌患者的门诊 PR 一样有效。
方法和分析：这是一项双臂、平行组、评估者盲法、单中心、随机对照试验。参与者将从四川大学华西医院招募，并按照 1:1 的比例随机分配到门诊组或家庭组。PR 方案包括自我管理和锻炼。锻炼包括热身（10 分钟）、有氧运动（20 分钟）、阻力训练（15 分钟）和冷却（10 分钟），持续 4 周，每周两次，无论是在家中还是在门诊进行。根据每次锻炼前后的改良 Borg 感知用力评分和心率调整运动强度。主要结局是干预后 EORTC QLQ-C30 和 LC 13 测量的 QoL。次要结局包括 6 分钟步行测试和爬楼梯测试测量的身体适应性和通过患者报告问卷和肺功能测量的症状严重程度。主要假设是，对于手术后肺癌患者，基于家庭的 PR 与门诊 PR 一样有效。
伦理和传播：该试验已获得华西医院伦理委员会的批准，并在中国临床试验注册中心注册。本研究的结果将通过同行评议的出版物和在国内外会议上的演讲进行传播。
试验注册号：ChiCTR2100053714。
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