International journal of chronic obstructive pulmonary disease · 2024
Comparison of a Supervised Home-Based Tele-Rehabilitation with Center-Based Pulmonary Rehabilitation: Protocol for a Randomized Non-Inferiority Multicenter Study in Ningxia.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Xin Hongxia, Wei Shuoshuo, Zheng Hao, Qi Yanchao, Xu Shuping, Wang Bei, Jiang Wangshu, Deng Ning, Chen Juan
Аннотация
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.
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.
Предметные рубрики MeSH
HumansTelerehabilitationPulmonary Disease, Chronic ObstructiveChinaTreatment OutcomeExercise TherapyExercise ToleranceMulticenter Studies as TopicRecovery of FunctionTime FactorsHome Care ServicesLungMiddle AgedRehabilitation CentersMalePatient Education as TopicRandomized Controlled Trials as TopicFemaleAgedEquivalence Trials as TopicFunctional StatusWalk Test