■肺康复(PR)是慢性阻塞性肺疾病(COPD)患者的有效干预措施。然而,不到5%的符合条件的人接受肺康复,主要是由于康复的可及性以及与旅行和运输相关的困难所限制。有监督的基于家庭的远程康复(SHTR)是基于中心的肺康复的替代模型。我们将确定有监督的基于家庭的远程康复是否不劣于基于中心的肺康复。
■参与者将接受为期8周的康复计划。肺康复包括四个主要模块:运动训练,教育,营养支持,以及心理和行为干预。我们主要关注运动训练和教育模块。教育模块包括有关运动训练的资料,营养,和心理学,它们在提供给每个参与者的教育小册子中呈现。失明的评估员将在基线时评估结果,干预后,干预后6个月。主要结果是6分钟步行距离的变化。次要结果将评估患者1分钟坐姿测试的变化,最大吸气压力(MIP),尺度(CAT,mMRC,HAD),隔膜超声(TD,DE,DIF),胸外肌肉体积和质量的变化,患者运动处方完成率,不良事件的发生,以及康复后和6个月随访期间的疾病恶化和再住院率。
■为了改善肺康复的可及性和与患者相关的结局,有必要提出一种替代的肺康复模式。该试验将确定有监督的基于家庭的远程康复是否不逊于传统的基于中心的肺康复。
■中国临床试验注册中心ChiCTR2300076969。2023年10月25日注册。
UNASSIGNED: Pulmonary rehabilitation (PR) is an effective intervention for people with chronic obstructive pulmonary disease (COPD). However, fewer than 5% of eligible individuals receive pulmonary rehabilitation, largely due to limited by the accessibility of rehabilitation and difficulties associated with travel and transport. Supervised home-based tele-rehabilitation (SHTR) is an alternative model to center-based pulmonary rehabilitation. We will determine whether supervised home-based tele-rehabilitation is non-inferior to center-based pulmonary rehabilitation.
UNASSIGNED: The participants will undergo an 8-week rehabilitation program. Pulmonary rehabilitation comprises four main modules: exercise training, education, nutritional support, and psychological and behavioral interventions. We mainly focus on the module of exercise training and education. The education module includes information on exercise training, nutrition, and psychology, which are presented in an educational booklet provided to each participant. Blinded assessors will evaluate the outcomes at baseline, post-intervention, and 6 months after the intervention. The primary outcome is the change in the 6-minute walking distance. Secondary outcomes will assess changes in the patients\' 1-minute sit-to-stand test, maximal inspiratory pressure (MIP), scales (CAT, mMRC, HAD), diaphragm ultrasound (TD, DE, DIF), changes in extrathoracic muscle volume and mass, completion rate of patient exercise prescriptions, occurrence of adverse events, as well as disease exacerbation and rehospitalization rates after rehabilitation and during the 6-month follow-up.
UNASSIGNED: In order to improve the accessibility of pulmonary rehabilitation and patient-related outcomes, it is necessary to propose an alternative model of pulmonary rehabilitation. This
trial will establish whether a supervised home-based tele-rehabilitation is not inferior to traditional center-based pulmonary rehabilitation.
UNASSIGNED: Chinese Clinical
Trial Registry ChiCTR2300076969. Registered on October 25, 2023.