Gong Chen, Feng Beibei, Wang Huashe, Wang Yafei, Yu Jiadan, Wang Biru, Chen Shi, Peng Junsheng, Wang Yuling
Department of Rehabilitation Medicine, The Sixth Affiliated Hospital, Sun Yat-sen University, No. 26, Yuancun 2nd Cross Road, Guangzhou, 510655, China.
Guangdong Provincial Clinical Research Center for Rehabilitation Medicine, Guangzhou, China.
BMC Sports Sci Med Rehabil. 2025 Aug 2;17(1):223. doi: 10.1186/s13102-025-01276-2.
Increasing evidence underscores the effectiveness of prehabilitation in improving postoperative outcomes in patients with cancer. However, evidence on structured exercise prehabilitation, specifically for functional recovery after esophagectomy, remains limited. Hence, this pilot study aimed to examine the feasibility and safety of a one-week exercise prehabilitation protocol and to explore its preliminary effects on functional capacity in patients with esophageal cancer undergoing surgery.
This is a parallel-group, randomized, open-label, pragmatic pilot trial. Patients with esophageal cancer awaiting surgery were randomly assigned to either the prehabilitation group or the control group. The prehabilitation group received a one-week structured exercise prehabilitation program that included respiratory, resistance and aerobic exercise before surgery, whereas the control group received no preoperative intervention. Feasibility was evaluated by the eligibility rate, recruitment rate, follow-up assessment rate, and exercise adherence rate. Safety was assessed by monitoring and recording any serious adverse events that occurred during the exercise program. Preliminary efficacy was determined via changes in functional capacity, postoperative complications, and quality of life.
Twenty-one patients were randomized, and 16 were included in the primary analysis. Prehabilitation is feasible, with a recognized eligibility rate (69%), recruitment rate (95%) and follow-up completion rate (76%). All (100%) participants attended each treatment session during the prehabilitation and postoperative rehabilitation phases. No serious adverse events were reported. A statistically significant improvement in the change in the 6-minute walking distance from baseline was found in the prehabilitation group after one week of prehabilitation intervention compared with the control group (P < 0.001). A significant interaction effect (group × time) was also observed (P = 0.011). There was no significant difference in the occurrence of postoperative complications between the groups. Prehabilitation also potentially improved the preoperative quality of life (P < 0.05).
The one-week structured exercise prehabilitation protocol is feasible and safe for esophagectomy patients and has the potential to enhance preoperative functional capacity and quality of life. These findings support further investigations in large-scale randomized controlled trials to validate the efficacy for clinical endpoints.
This trial was retrospectively registered with the Chinese Clinical Trial Registry on 25/09/2024 (ChiCTR2400090172).
越来越多的证据强调了术前康复训练在改善癌症患者术后结局方面的有效性。然而，关于结构化运动术前康复训练，特别是对食管癌切除术后功能恢复的证据仍然有限。因此，这项试点研究旨在检验为期一周的运动术前康复训练方案的可行性和安全性，并探讨其对接受手术的食管癌患者功能能力的初步影响。
这是一项平行组、随机、开放标签的实用性试点试验。等待手术的食管癌患者被随机分配到术前康复训练组或对照组。术前康复训练组在手术前接受为期一周的结构化运动术前康复训练计划，包括呼吸、抗阻和有氧运动，而对照组未接受术前干预。通过入选率、招募率、随访评估率和运动依从率评估可行性。通过监测和记录运动计划期间发生的任何严重不良事件来评估安全性。通过功能能力、术后并发症和生活质量的变化来确定初步疗效。
21例患者被随机分组，16例纳入主要分析。术前康复训练是可行的，入选率（69%）、招募率（95%）和随访完成率（76%）均得到认可。所有（（100%）参与者在术前康复训练和术后康复阶段都参加了每次治疗课程。未报告严重不良事件。与对照组相比，术前康复训练组在进行一周的术前康复训练干预后，从基线开始的6分钟步行距离变化有统计学意义的改善（P < 0.001）。还观察到显著的交互作用（组×时间）（P = 0.011）。两组术后并发症的发生率没有显著差异。术前康复训练也可能改善了术前生活质量（P < 0.05）。
为期一周的结构化运动术前康复训练方案对食管癌切除术患者是可行且安全的，并且有可能提高术前功能能力和生活质量。这些发现支持在大规模随机对照试验中进行进一步研究，以验证对临床终点的疗效。
本试验于2024年9月25日在中国临床试验注册中心进行回顾性注册（ChiCTR2400090172）。
