Comparison of a Supervised Home-Based Tele-Rehabilitation with Center-Based Pulmonary Rehabilitation: Protocol for a Randomized Non-Inferiority Multicenter Study in Ningxia

Abstract

Hongxia Xin,1,2,* Shuoshuo Wei,1,3,* Hao Zheng,4,* Yanchao Qi,5,* Shuping Xu,6,* Bei Wang,2 Wangshu Jiang,7 Ning Deng,7,* Juan Chen1,2,* 1Department 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; 2Department of Pulmonary and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People’s Republic of China; 3Department of Pulmonary and Critical Care Medicine, Affiliated Yijishan Hospital, Wannan Medical College, Wuhu, Anhui, People’s Republic of China; 4Department of Pulmonary and Critical Care Medicine, Yanchi County People’s Hospital, Wuzhong, Ningxia, People’s Republic of China; 5Department of Pulmonary and Critical Care Medicine, Second People’s Hospital of Shizuishan, Shizuishan, Ningxia, People’s Republic of China; 6Department of Pulmonary and Critical Care Medicine II, Wuzhong People’s Hospital, WuZhong, Ningxia, People’s Republic of China; 7Ministry of Education Key Laboratory of Biomedical Engineering, College of Biomedical Engineering and Instrument Science, Zhejiang University, Hangzhou, People’s Republic of China*These authors contributed equally to this workCorrespondence: Ning Deng, Ministry of Education Key Laboratory of Biomedical Engineering, College of Biomedical Engineering and Instrument Science, Zhejiang University, Hangzhou, 310058, People’s Republic of China, Email [email protected] Juan Chen, Department of Pulmonary and Critical Care Medicine, General Hospital of Ningxia Medical University, Yongan Lane, Xingqing District, Yinchuan, Ningxia, 750004, People’s Republic of China, Email [email protected]: 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. Keywords: COPD, tele-rehabilitation, protocol, randomized non-inferiority trial

Keywords

• copd
• tele-rehabilitation
• protocol
• randomized non-inferiority trial