King's College London, Cicely Saunders Institute, Division of Palliative Care, Policy & Rehabilitation, London, UK.
NIHR Respiratory Biomedical Research Unit, Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London, UK; Harefield Pulmonary Rehabilitation Team, Harefield Hospital, Harefield, Middlesex, UK.
Lancet Respir Med. 2016 Jan;4(1):27-36. doi: 10.1016/S2213-2600(15)00503-2. Epub 2015 Dec 15.
Skeletal muscle dysfunction and exercise intolerance are common in severe chronic obstructive pulmonary disease (COPD). We assessed the effectiveness of neuromuscular electrical stimulation (NMES) as a home-based exercise therapy.
In this double-blind, placebo-controlled trial, undertaken across three UK National Health Service sites, we randomly assigned (1:1) adults with COPD, a forced expiratory volume in 1 s (FEV1) less than 50% predicted, and incapacitating breathlessness (Medical Research Council dyspnoea scale ≥4) to receive active or placebo NMES, daily over a 6-week period. Randomisation was by an independent system using minimisation to balance age, GOLD stage, and quadriceps strength. Participants and outcome assessors were masked to group allocation. The primary endpoint was change in 6-min walk test (6MWT) distance at 6 weeks. Analysis was by intention to treat. The trial was registered as ISRCTN15985261 and is now closed.
Between June 29, 2012, and July 4, 2014, we enrolled 73 participants, of whom 52 participants were randomly assigned; 25 to receive active NMES and 27 to placebo NMES. Change in 6MWT distance was greater in the active NMES group (mean 29·9 [95% CI 8·9 to 51·0]) compared with in the placebo group (-5·7 [-19·9 to 8·4]; mean difference at 6 weeks 35·7 m [95% CI 10·5 to 60·9]; p=0·005). Sensitivity analyses for complete-cases and adjustment for baseline values showed similar results. 6 weeks after stopping the intervention the effect waned (7·3 m [95% CI -32·5 to 47·0]; p=0·50). The proportion of participants who had adverse events was similar between groups (five [20%] in the active NMES group and nine [33%] in the placebo group). Two participants, one from each group, reported persistent erythema, which was considered to be possibly related to NMES and the use of adhesive electrodes.
NMES improves functional exercise capacity in patients with severe COPD by enhancing quadriceps muscle mass and function. These data support the use of NMES in the management of patients unable to engage with conventional pulmonary rehabilitation. More work is needed to study how to maintain the effect.
National Institute for Health Research.
严重慢性阻塞性肺疾病（COPD）患者常存在骨骼肌功能障碍和运动不耐受。我们评估了神经肌肉电刺激（NMES）作为一种家庭运动疗法的有效性。
在这项在英国三家国民保健服务（NHS）机构进行的双盲、安慰剂对照试验中，我们将 1 秒用力呼气量（FEV1）低于预计值 50%且伴有使人虚弱的呼吸困难（改良英国医学研究理事会呼吸困难量表≥4 级）的 COPD 成人患者随机分为 NMES 治疗组或安慰剂 NMES 治疗组，两组均每天接受 NMES 治疗，为期 6 周。通过最小化法对年龄、GOLD 分期和股四头肌力量进行平衡，以 1:1 的比例进行随机分组。参与者和结局评估者均对分组情况设盲。主要终点为 6 分钟步行试验（6MWT）距离在 6 周时的变化。采用意向治疗进行分析。该试验已在 ISRCTN 注册，注册号为 ISRCTN82215758。
2012 年 6 月 29 日至 2014 年 7 月 4 日，我们共纳入 73 名参与者，其中 52 名被随机分配，25 名接受 NMES 治疗，27 名接受安慰剂 NMES 治疗。NMES 治疗组的 6MWT 距离改善（平均 29.9 [95%CI 8.9 至 51.0]）优于安慰剂组（-5.7 [-19.9 至 8.4]）；6 周时的平均差值为 35.7m [95%CI 10.5 至 60.9]；p=0.005）。对完全病例进行敏感性分析和对基线值进行调整的结果相似。干预停止后 6 周，效果减弱（7.3m [95%CI -32.5 至 47.0]）；p=0.50）。两组的不良事件发生率相似（NMES 治疗组 5 例[20%]，安慰剂组 9 例[33%]）。两组各有 1 名参与者报告出现持续性红斑，考虑与 NMES 和粘性电极的使用有关。
NMES 可通过增强股四头肌的质量和功能来改善严重 COPD 患者的功能性运动能力。这些数据支持将 NMES 用于管理无法进行常规肺康复的患者。需要进一步研究如何维持疗效。
英国国家卫生研究院。
