Hildebrand Nicole D, Wijma Allard G, Bongers Bart C, Rensen Sander S, den Dulk Marcel, Klaase Joost M, Olde Damink Steven W M
Department of Surgery, Maastricht University Medical Center+, Maastricht, Netherlands.
Department of Surgery, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Netherlands.
JMIR Res Protoc. 2023 Sep 7;12:e46526. doi: 10.2196/46526.
Morbidity rates in pancreatic surgery are high, and frail patients with low aerobic capacity are especially at risk of complications and require prophylactic interventions. Previous studies of small patient cohorts receiving intra-abdominal surgery have shown that an exercise prehabilitation program increases aerobic capacity, leading to better treatment outcomes.
In this study, we aim to assess the feasibility of a home-based exercise prehabilitation program in unfit patients scheduled for pancreatic surgery on a larger scale.
In this multicenter study, adult patients scheduled for elective pancreatic surgery with a preoperative oxygen uptake (VO) at the ventilatory anaerobic threshold ≤13 mL/kg/min or a VO at peak exercise ≤18 mL/kg/min will be recruited. A total of 30 patients will be included in the 4-week, home-based, partly supervised exercise prehabilitation program. The program comprises 25-minute high-intensity interval training on an advanced cycle ergometer 3 times a week. Training intensity will be based on steep ramp test performance (ie, a short-term maximal exercise test on a cycle ergometer), aiming to improve aerobic capacity. Twice a week, patients will perform functional task exercises to improve muscle function and functional mobility. A steep ramp test will be repeated weekly, and training intensity will be adjusted accordingly. Next to assessing the feasibility (participation rate, reasons for nonparticipation, adherence, dropout rate, reasons for dropout, adverse events, and patient and therapist appreciation) of this program, individual patients' responses to prehabilitation on aerobic capacity, functional mobility, body composition, quality of life, and immune system factors will be evaluated.
Recruitment for this study began in January 2022 and is expected to be completed in the summer of 2023.
Results of this study will provide important clinical and scientific knowledge on the feasibility of a partly supervised home-based exercise prehabilitation program in a vulnerable patient population. This might ease the path to implementing prehabilitation programs in unfit patients undergoing complex abdominal surgery, such as pancreatic surgery.
ClinicalTrials.gov NCT05496777; https://classic.clinicaltrials.gov/ct2/show/NCT05496777.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46526.
胰腺手术的发病率很高，有氧运动能力低的体弱患者尤其有并发症风险，需要预防性干预。先前对接受腹部手术的小患者队列的研究表明，运动预康复计划可提高有氧运动能力，从而带来更好的治疗效果。
在本研究中，我们旨在更大规模地评估针对计划接受胰腺手术的身体不适患者的居家运动预康复计划的可行性。
在这项多中心研究中，将招募计划接受择期胰腺手术、术前通气无氧阈时的摄氧量（VO）≤13 mL/kg/min或运动峰值时的VO≤18 mL/kg/min的成年患者。总共30名患者将纳入为期4周的居家、部分监督的运动预康复计划。该计划包括每周3次在高级自行车测力计上进行25分钟的高强度间歇训练。训练强度将基于陡坡测试表现（即在自行车测力计上进行的短期最大运动测试），旨在提高有氧运动能力。患者每周将进行两次功能性任务锻炼，以改善肌肉功能和功能活动能力。每周将重复进行一次陡坡测试，并相应调整训练强度。除了评估该计划的可行性（参与率、不参与原因、依从性、退出率、退出原因、不良事件以及患者和治疗师的满意度）外，还将评估个体患者在有氧运动能力、功能活动能力、身体成分、生活质量和免疫系统因素方面对预康复的反应。
本研究于2022年1月开始招募，预计2023年夏季完成。
本研究结果将为针对脆弱患者群体的部分监督居家运动预康复计划的可行性提供重要的临床和科学知识。这可能会为在接受复杂腹部手术（如胰腺手术）的身体不适患者中实施预康复计划铺平道路。
ClinicalTrials.gov NCT05496777；https://classic.clinicaltrials.gov/ct2/show/NCT05496777。
国际注册报告识别码（IRRID）：DERR1-10.2196/46526。
