Efficacy of community-based respiratory neuromuscular electrical stimulation on exercise capacity and quality of life in stable COPD: a randomized multicenter parallel-controlled trial protocol

Background: Chronic Obstructive Pulmonary Disease (COPD) is a common and prevalent condition that poses a significant threat to human health. Respiratory muscle fatigue is one of the common clinical manifestations of COPD. Currently, no effective treatment has been proposed to alleviate COPD symptoms. Respiratory neuromuscular electrical stimulation (RNES) enhances diaphragmatic contraction, lung volume, and ventilation through selective activation of type II muscle fibers, as evidenced in neurological and respiratory critical care settings. Although many COPD patients are managed through community care interventions, the efficacy of RNES in treating COPD patients has not been sufficiently studied. Here, we aim to investigate whether RNES can improve exercise capacity in COPD patients, as measured by 6-minute walk distance (6MWT). Objectives: To determine the efficacy of a community-based pulmonary rehabilitation (PR) program incorporating RNES on exercise capacity and symptoms in COPD patients. To evaluate its feasibility as a novel, affordable and accessible community PR model for COPD management. Design: This is a prospective, multicenter, randomized, parallel-controlled clinical trial, enrolling 60 patients with COPD. Methods: Sixty patients with stable COPD receiving inhalation therapy in 11 community health service centers in Beijing will be enrolled in the study. The potential of RNES to improve exercise capacity within this population will be explored in the study cohort. The enrolled patients will be randomized into two groups in a 1:1 ratio: control group (to receive conventional treatment) and experimental group (to receive conventional treatment plus RNES). During the treatment, the control group will receive conventional treatment without RNES, and those in the experimental group will receive 20/40 treatments over 6/12 weeks (1 session per day for 30 min) of RNES rehabilitation-assisted therapy plus conventional treatment. The primary outcome is exercise capacity based on changes in 6MWT at 12 weeks. The secondary outcome measures include changes from baseline in several indicators: dyspnea questionnaire, impact on daily living, anxiety and depression, pulmonary function, diaphragm function, respiratory muscle strength and body composition. Discussion: This clinical trial is designed to investigate whether rehabilitation assistance therapy with RNES will improve diaphragm mobility, respiratory muscle strength and endurance, enhance pulmonary ventilation, tidal volume, and promote alveolar carbon dioxide excretion in patients with stable COPD, which will improve the activity and exercise capacity. This study investigates the feasibility of RNES as a scalable rehabilitation intervention for COPD management in community healthcare settings. Conclusion: RNES will improve exercise capacity, quality of life in patients with COPD. Trial registration: The protocol has been registered at the Chinese Clinical Trial Registry (ChiCTR2200061675).