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胸外科术前康复研究方案:一项比较短程家庭多模式方案与有氧运动训练用于电视辅助胸腔镜手术肺叶切除术患者的随机实用试验。

The protocol for the prehabilitation for thoracic surgery study: a randomized pragmatic trial comparing a short home-based multimodal program to aerobic training in patients undergoing video-assisted thoracoscopic surgery lobectomy.

机构信息

Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.

Department of Medical Research Center, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.

出版信息

Trials. 2023 Mar 15;24(1):194. doi: 10.1186/s13063-023-07220-4.

Abstract

BACKGROUND

Prehabilitation has been shown to have a positive effect on the postoperative recovery of functional capacity in patients undergoing video-assisted thoracoscopic surgery (VATS) lobectomy. The optimal way to implement prehabilitation programs, such as the optimal forms of prehabilitation, duration, intensity, and methods to improve compliance, remained to be studied. This Prehabilitation for Thoracic Surgery Study will compare the effectiveness of multimodal and aerobic training-only programs in patients undergoing thoracoscopic lobectomy.

METHODS

This randomized pragmatic trial will be conducted in Peking Union Medical College Hospital (PUMCH) and include 100 patients who are eligible to undergo VATS lobectomy. Patients will be randomized to a multimodal or aerobic training group. Prehabilitation training guidance will be provided by a multidisciplinary care team. The patients in the multimodal group will perform aerobic exercises, resistance exercises, breathing exercises, psychological improvement strategies, and nutritional supplementation. Meanwhile, the patients in the aerobic group will conduct only aerobic exercises. The interventions will be home-based and supervised by medical providers. The patients will be followed up until 30 days after surgery to investigate whether the multimodal prehabilitation program differs from the aerobic training program in terms of the magnitude of improvement in functional capability pre- to postoperatively. The primary outcome will be the perioperative 6-min walk distance (6MWD). The secondary outcomes will include the postoperative pulmonary functional recovery status, health-related quality of life score, incidence of postoperative complications, and clinical outcomes.

DISCUSSION

Prehabilitation remains a relatively new approach that is not widely performed by thoracic surgery patients. The existing studies mainly focus on unimodal interventions. While multimodal prehabilitation strategies have been shown to be preferable to unimodal strategies in a few studies, the evidence remains scarce for thoracic surgery patients. The results of this study will contribute to the understanding of methods for thoracoscopic lobectomy patients.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04049942 . Registered on August 8, 2019.

摘要

背景

术前强化已被证明对接受电视辅助胸腔镜手术(VATS)肺叶切除术的患者术后功能能力的恢复有积极影响。实施术前强化方案的最佳方式,如术前强化的最佳形式、持续时间、强度以及提高依从性的方法,仍有待研究。这项胸外科术前强化研究将比较多模式和仅有氧训练方案在接受胸腔镜肺叶切除术中的效果。

方法

这是一项在北京协和医院进行的随机实用试验,纳入 100 名符合条件行 VATS 肺叶切除术的患者。患者将被随机分配到多模式或有氧训练组。多模式组患者将进行有氧运动、阻力运动、呼吸练习、心理改善策略和营养补充。同时,有氧组患者仅进行有氧运动。干预措施将基于家庭,并由医疗提供者进行监督。患者将接受随访,直到术后 30 天,以调查多模式术前强化方案在改善术后功能能力方面是否与有氧训练方案不同。主要结局将是围手术期 6 分钟步行距离(6MWD)。次要结局包括术后肺功能恢复情况、健康相关生活质量评分、术后并发症发生率和临床结局。

讨论

术前强化仍然是一种相对较新的方法,在胸外科患者中尚未广泛实施。现有的研究主要集中在单模式干预上。虽然一些研究表明多模式术前强化策略优于单模式策略,但在胸外科患者中证据仍然很少。这项研究的结果将有助于了解胸腔镜肺叶切除术患者的方法。

试验注册

ClinicalTrials.gov NCT04049942。于 2019 年 8 月 8 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ea54/10018899/54fe4c4dc18a/13063_2023_7220_Fig1_HTML.jpg

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