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Stimulation of both inspiratory plus expiratory muscles versus diaphragm-only paradigm for rehabilitation in severe COPD patients: a randomised controlled pilot study [with consumer summary]
Zhao Z, Sun W, Zhao X, Wang X, Lin Y, Zhang S, Li Z, Lu Y, Gong J, Yu Y, Li B, Hu X, Li Y, Tong Z
European Journal of Physical and Rehabilitation Medicine 2022 Jun;58(3):487-96
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Chronic obstructive pulmonary disease (COPD), a progressive lung disease, might improve with neuromuscular electrical stimulation. No trials on inspiratory plus expiratory neuromuscular electrical stimulation have been conducted yet. AIM: To evaluate the safety and effectiveness of inspiratory plus expiratory neuromuscular electrical stimulation in subjects with severe COPD. DESIGN: This was a multicentre, prospective, randomised controlled trial. SETTING: The subjects were outpatients enrolled from Beijing Chao-Yang Hospital affiliated with Capital Medical University, Tianjin Chest Hospital, and the First Hospital of Hebei Medical University. POPULATION: Subjects had stable COPD with severe respiratory impairment. METHODS: Using a computer statistical software, 120 stable subjects were randomly allocated (1:1) to receive inspiratory plus expiratory neuromuscular electrical stimulation (study group) and diaphragm pacing (control group). Demographic and clinical data were collected before, and after 2, and 4 weeks of the trial. The intention-to-treat analysis was conducted. The primary outcome was to analyse the changes in functional exercise capacity, estimated as six-minute walk distance (6-MWD), following electrical stimulation for 4 weeks. The secondary outcomes were changes in modified Medical Research Council score, forced expiratory volume in 1 second (FEV1), FEV1% predicted, and FEV1 ratio forced vital capacity (FEV1/FVC) following electrical stimulation for 4 weeks. RESULTS: The change in 6-MWD was greater in the study group (65.53 +/- 39.45 metres) than in the control group (26.66 +/- 32.65 metres). The mean between-group difference at the fourth week was 29.07 metres (95% CI 16.098 to 42.035; p < 0.001). There were no significant between-group differences in the secondary outcomes after 4 weeks of electrical stimulation. For GOLD-4 COPD subjects, FEV1 and FEV1/FVC improved in the study group (p < 0.05). No electrical stimulation-related serious adverse events were observed in either group. CONCLUSIONS: 6-MWD were increased significantly, without adverse events, after four weeks of treatment of inspiratory plus expiratory neuromuscular electrical stimulation in stable patients with severe COPD, suggesting that this protocol benefits COPD rehabilitation.

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