基于监督的家庭远程康复与中心式肺康复的比较：宁夏一项随机非劣效性多中心研究方案。
Comparison of a Supervised Home-Based Tele-Rehabilitation with Center-Based Pulmonary Rehabilitation: Protocol for a Randomized Non-Inferiority Multicenter Study in Ningxia.
机构信息
Department of Key Laboratory of Ningxia Stem Cell and Regenerative Medicine, Institute of Medical Sciences, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People's Republic of China.
Department of Pulmonary and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People's Republic of China.
出版信息
Int J Chron Obstruct Pulmon Dis. 2024 Jul 25;19:1707-1719. doi: 10.2147/COPD.S467945. eCollection 2024.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR2300076969. Registered on October 25, 2023.
背景
肺康复（PR）是治疗慢性阻塞性肺疾病（COPD）患者的有效干预手段。然而，只有不到 5%的符合条件的患者接受了肺康复治疗，这主要是由于康复的可及性有限，以及与旅行和交通相关的困难。监督下的家庭远程康复（SHTR）是一种替代中心式肺康复的模式。我们将确定监督下的家庭远程康复是否不劣于中心式肺康复。
方法
参与者将接受 8 周的康复计划。肺康复包括四个主要模块：运动训练、教育、营养支持和心理行为干预。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、营养和心理的信息，这些信息以提供给每位参与者的教育手册的形式呈现。盲法评估员将在基线、干预后和干预后 6 个月评估结果。主要结局是 6 分钟步行距离的变化。次要结局将评估患者 1 分钟坐站测试、最大吸气压力（MIP）、量表（CAT、mMRC、HAD）、膈肌超声（TD、DE、DIF）、胸外肌肉体积和质量的变化、患者运动处方的完成率、不良事件的发生情况，以及康复后和 6 个月随访期间疾病恶化和再住院率。
讨论
为了提高肺康复的可及性和患者相关结局，有必要提出一种替代的肺康复模式。本试验将确定监督下的家庭远程康复是否不劣于传统的中心式肺康复。
试验注册
中国临床试验注册中心 ChiCTR2300076969。注册于 2023 年 10 月 25 日。
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