Department of Pulmonary Rehabilitation, Philipps-University of Marburg, Marburg, Germany
Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany.
BMJ Open Respir Res. 2023 Nov 22;10(1):e001913. doi: 10.1136/bmjresp-2023-001913.
People with very severe chronic obstructive pulmonary disease (COPD) using nocturnal non-invasive ventilation (NIV) for chronic hypercapnic respiratory failure (CHRF) experience reduced exercise capacity and severe dyspnoea during exercise training (ET). The use of NIV during ET can personalise training during pulmonary rehabilitation (PR) but whether high-intensity NIV (HI-NIV) during exercise is accepted and improves outcomes in these extremely physically limited patients is unknown. The aim of this trial was to determine if ET with HI-NIV during PR was more effective than without at improving exercise capacity and reducing dyspnoea during exercise.
Patients with COPD, CHRF and nocturnal-NIV were randomised to supervised cycle-ET as part of PR with HI-NIV or without (control). Primary outcome was change in cycle endurance time (ΔCET), while secondary outcomes were dyspnoea at isotime during the cycle endurance test and during ET-sessions and for the HI-NIV group, post-trial preferred exercising method.
Twenty-six participants (forced expiratory volume in 1 s 22±7%pred, PaCO51±7 mm Hg) completed the trial (HI-NIV: n=13, ET: IPAP 26±3/EPAP 6±1 cm HO; control n=13). At completion of a 3 week ET-programme, no significant between-group differences in ΔCET were seen (HI-NIV-control: Δ105 s 95% CI (-92 to 302), p=0.608). Within-group ΔCET was significant (HI-NIV: +246 s 95% CI (61 to 432); control: +141 s 95% CI (60 to 222); all p<0.05). The number of responders (Δ>minimal important difference (MID): n=53.8%) was the same in both groups for absolute ΔCET and 69.2% of control and 76.9% of the HI-NIV group had a %change>MID.Compared with control, the HI-NIV group reported less isotime dyspnoea (Δ-2.0 pts. 95% CI (-3.2 to -0.8), p=0.005) and during ET (Δ-3.2 pts. 95% CI (-4.6 to -1.9), p<0.001). Most of the HI-NIV group (n=12/13) preferred exercising with NIV.
In this small group of patients with very severe COPD requiring nocturnal NIV, participation in an ET-programme during PR significantly improved exercise capacity irrespective of HI-NIV use. Reported dyspnoea was in favour of HI-NIV.
NCT03803358.
使用夜间无创通气（NIV）治疗慢性高碳酸血症呼吸衰竭（CHRF）的极重度慢性阻塞性肺疾病（COPD）患者在运动训练（ET）期间运动能力下降，且严重呼吸困难。在 ET 期间使用 NIV 可以使肺康复（PR）期间的训练个性化，但在这些身体极度受限的患者中，高流量 NIV（HI-NIV）在运动时是否被接受并改善预后尚不清楚。本试验旨在确定 PR 期间使用 HI-NIV 的 ET 是否比不使用 HI-NIV 更能有效提高运动能力并减轻运动时的呼吸困难。
患有 COPD、CHRF 和夜间 NIV 的患者被随机分配接受监督循环 ET，作为 PR 的一部分，包括 HI-NIV 或不接受（对照组）。主要结局是循环耐力时间（ΔCET）的变化，次要结局是循环耐力测试期间和 ET 期间的等时呼吸困难以及 HI-NIV 组的试验后首选运动方法。
26 名参与者（1 秒用力呼气量 22±7%预测值，PaCO51±7 mm Hg）完成了试验（HI-NIV：n=13，ET：IPAP 26±3/EPAP 6±1 cm HO；对照组 n=13）。在完成 3 周 ET 计划后，两组之间的 ΔCET 无显著差异（HI-NIV-对照组：Δ105 s 95%CI（-92 至 302），p=0.608）。组内ΔCET 有显著差异（HI-NIV：+246 s 95%CI（61 至 432）；对照组：+141 s 95%CI（60 至 222）；均 p<0.05）。两组的绝对 ΔCET 应答者（Δ>最小临床重要差异（MID）：n=53.8%）和对照组的 69.2%和 HI-NIV 组的 76.9%的百分比变化>MID 的比例相同。与对照组相比，HI-NIV 组报告的等时呼吸困难减少（Δ-2.0 分，95%CI（-3.2 至 -0.8），p=0.005）和 ET 期间的呼吸困难（Δ-3.2 分，95%CI（-4.6 至 -1.9），p<0.001）。HI-NIV 组的大多数患者（n=12/13）更喜欢使用 NIV 进行运动。
在需要夜间 NIV 的极重度 COPD 患者中，参加 PR 期间的 ET 计划可显著提高运动能力，而与 HI-NIV 的使用无关。报告的呼吸困难对 HI-NIV 有利。
NCT03803358。
