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肺移植术后住院康复评估(PIRATE):一项可行性随机对照试验。

Post-operative, inpatient rehabilitation after lung transplant evaluation (PIRATE): A feasibility randomized controlled trial.

机构信息

Physiotherapy Department, 4th Floor Philip Block, the Alfred, Alfred Health, Melbourne, VIC, Australia.

Level 4, The Alfred Centre, La Trobe University, Melbourne, VIC, Australia.

出版信息

Physiother Theory Pract. 2023 Jul 3;39(7):1406-1416. doi: 10.1080/09593985.2022.2041779. Epub 2022 Feb 22.

Abstract

BACKGROUND

Postoperative rehabilitation is crucial following lung transplantation (LTx); however, it is unclear whether intensive rehabilitation is feasible to deliver in the acute setting. We aimed to establish the feasibility and safety of intensive acute physiotherapy post-LTx.

METHODS

This feasibility trial randomized 40 adults following bilateral sequential LTx to either standard (once-daily) or intensive (twice-daily) physiotherapy. Primary outcomes were feasibility (recruitment and delivery of intensive intervention) and safety. Secondary outcomes included six-minute walk test; 60-second sit-to-stand; grip strength; physical activity; pain; EQ-5D-5L; length of stay; and readmissions. Data were collected at baseline, week 3, and week 10 post-LTx. ClinicalTrials.gov #NCT03095859.

RESULTS

Of 83 LTx completed during the trial, 49% were eligible and 48% provided consent. Median age was 61 years {range 18-70}; waitlist time 85 days [IQR 35-187]. Median time to first mobilization was 2 days [2-3]. Both groups received a median of 10 [7-14] standard interventions post-randomization. A median of 9 [6-18] individual intensive interventions were attempted (86% successful), the most common barrier being medical procedures/investigations (67%). No intervention-related adverse events or between-group differences in secondary outcomes were observed.

CONCLUSIONS

Acute, intensive physiotherapy was feasible and safe post-LTx. This trial provides data to underpin definitive trials to establish efficacy.

摘要

背景

肺移植(LTx)后康复至关重要;然而,目前尚不清楚在急性期是否可以进行强化康复治疗。我们旨在确定 LTx 后强化急性物理治疗的可行性和安全性。

方法

这项可行性试验将 40 名双侧序贯 LTx 后的成年人随机分为标准(每日一次)或强化(每日两次)物理治疗组。主要结局是可行性(强化干预的招募和实施)和安全性。次要结局包括 6 分钟步行试验;60 秒坐立站起;握力;身体活动;疼痛;EQ-5D-5L;住院时间;和再入院率。数据在 LTx 后基线、第 3 周和第 10 周收集。ClinicalTrials.gov #NCT03095859。

结果

在试验期间完成的 83 例 LTx 中,49%符合条件,48%同意参与。中位年龄为 61 岁{范围 18-70};等待时间 85 天[IQR 35-187]。首次活动的中位时间为 2 天[2-3]。两组在随机分组后均接受了中位数为 10[7-14]次标准干预。中位数尝试了 9[6-18]次个体化强化干预(成功率为 86%),最常见的障碍是医疗程序/检查(67%)。未观察到与干预相关的不良事件或组间次要结局差异。

结论

LTx 后急性强化物理治疗是可行且安全的。这项试验提供了数据来支持确定疗效的确定性试验。

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