Study protocol for evaluating the efficacy of early pulmonary rehabilitation combined with an internet-based patient management model in patients with chronic obstructive pulmonary disease: A practical, multicentre, randomized controlled study from China

Background Chronic obstructive pulmonary disease, a preventable and treatable disease, is characterized by persistent respiratory symptoms and airflow limitations, with high incidence, disability, mortality, and disease burden. Currently, drug treatments mainly include bronchodilators and glucocorticoids, which are used to alleviate symptoms and improve lung function. Traditional medical care models and patients' lack of understanding of the disease result in regular and long-term hospitalizations, affect patients’ quality of life and cause a need to explore more effective comprehensive intervention plans.

Methods This study is designed as a multicentre, randomized controlled trial consisting of three parallel groups. Group A will receive early pulmonary rehabilitation in the hospital and remote internet pulmonary rehabilitation after discharge. Group B will receive the same early pulmonary rehabilitation in the hospital but outpatient pulmonary rehabilitation after discharge for 8 weeks and routine follow-up management. Group C will receive outpatient pulmonary rehabilitation during a stable period of 3–4 weeks after discharge and routine follow-up management. One thousand four hundred eighty-two patients (Group A=Group B=Group C=494) will be enrolled from ten centres in China. The primary outcome measure will be the mean difference in the change in readmission rates due to acute exacerbation at 90 days and the 12-month readmission rate due to acute exacerbation. The secondary outcomes will mainly include differences in all-cause mortality; the number of acute exacerbations; COPD Assessment Test (CAT), Modified Medical Research Council (mMRC) scale, and St. George's Respiratory Questionnaire (SGRQ) scores; the pulmonary rehabilitation treatment completion rate; patient compliance; and patient and physician satisfaction scores among the three groups at 3, 6, and 12 months after the different interventions. In addition, the proportion of people with≥2 acute exacerbations within 12 months and the time of the first acute exacerbation will also be included.

Conclusions This study aims to further verify the substitutability of remote internet pulmonary rehabilitation for outpatient rehabilitation and its short-term and long-term effects in patients, providing comprehensive interventional evidence for the treatment of chronic obstructive pulmonary disease.