RATIONALE Inspiratory muscle training (IMT) improves respiratory muscle function in patients with weaning difficulties. IMT protocols involve performing daily sets of breaths against external loads. However, the impact of IMT on weaning outcomes while incorporating sham control interventions remains unclear. OBJECTIVES To compare the effects of a high-intensity IMT (Hi-IMT) intervention with a sham low-intensity (Lo-IMT) control group on weaning outcomes, respiratory muscle and pulmonary function 28 days after inclusion, in patients with weaning difficulties. METHODS Both groups underwent daily IMT sessions until successful weaning or a maximum of 28 days. The Hi-IMT group (n=44, 61% male, 57±15 years) performed maximal inspirations initiated from residual volume against an external load representing 30-50% of maximal inspiratory pressure (PImax), while the control group (n=46, 52% male, 60±12 years) performed maximal inspirations against a load ≤10% PImax. MEASUREMENTS AND MAIN RESULTS Training adherence (completed/planned sessions) was comparable between the groups (Hi-IMT: 77±20%, Lo-IMT: 72±17%, p=0.25). Weaning success (64% Hi-IMT and 76% Lo-IMT; p=0.43) and weaning duration (Hi-IMT: 45±48 days, Lo-IMT: 37±26 days, p=0.33) were similar between groups. Both groups similarly improved PImax (Hi-IMT: +15cmH2O [95%CI: 9 ; 20], Lo-IMT: +14cmH2O [95%CI: 9 ; 19], p=0.72). Forced vital capacity improved more in the Hi-IMT than Lo-IMT group (Hi-IMT: +0.33L [95%CI: 0.22 ; 0.43], Lo-IMT: +0.16L [95%CI: 0.07 ; 0.25], p=0.04). CONCLUSIONS Both high-intensity IMT and sham low-intensity IMT, with high adherence to the protocol, resulted in similar weaning success rates and pronounced improvements in maximal inspiratory muscle strength. Clinical trial registration available at www. CLINICALTRIALS gov, ID: NCT03240263.

中文翻译：

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高强度和假吸气肌训练的脱机成功率相似：一项随机对照试验 （IMweanT）。


基本原理吸气肌训练 （IMT） 可改善脱机困难患者的呼吸肌功能。IMT 协议包括针对外部负荷进行每日呼吸。然而，IMT 在纳入假控制干预时对脱机结局的影响仍不清楚。目的 比较高强度 IMT （Hi-IMT） 干预与假低强度 （Lo-IMT） 对照组对脱机困难患者入组后 28 天脱机结局、呼吸肌和肺功能的影响。方法 两组均每日进行 IMT 治疗，直至成功脱机或最长 28 天。Hi-IMT 组 （n=44,61% 男性，57±15 岁） 对代表最大吸气压 （PImax） 30-50% 的外部负荷进行从残余量开始的最大吸气，而对照组 （n=46,52% 男性，60±12 岁） 对负荷 ≤10% PImax） 进行最大吸气。测量和主要结果 两组之间的训练依从性（完成/计划的课程）相当 （Hi-IMT： 77±20%，Lo-IMT： 72±17%，p = 0.25）。两组间脱机成功率 （64% Hi-IMT 和 76% Lo-IMT;p=0.43） 和脱机持续时间 （Hi-IMT： 45±48 天，Lo-IMT： 37±26 天，p=0.33） 相似。两组 PImax 同样改善 （Hi-IMT：+15cmH2O [95%CI： 9 ; 20]，Lo-IMT：+14cmH2O [95%CI： 9 ; 19]，p=0.72）。Hi-IMT 组的用力肺活量改善幅度大于 Lo-IMT 组 （Hi-IMT： +0.33L [95%CI： 0.22 ; 0.43]，Lo-IMT： +0.16L [95%CI： 0.07 ; 0.25]，p = 0.04）。结论高强度 IMT 和假低强度 IMT 均对方案依从性高，脱机成功率相似，最大吸气肌力量显著改善。临床试验注册可在 www. CLINICALTRIALS gov， ID： NCT03240263.