Department of Anesthesiology and Operative Intensive Care Medicine (CVK/CCM), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Chariteplatz 1, 10117, Berlin, Germany.
Institute for Medical Information Processing, Biometry, and Epidemiology - IBE, Ludwig-Maximilians-Universität München, Munich, Germany.
Trials. 2022 Jun 6;23(1):468. doi: 10.1186/s13063-022-06401-x.
Frailty is expressed by a reduction in physical capacity, mobility, muscle strength, and endurance. (Pre-)frailty is present in up to 42% of the older surgical population, with an increased risk for peri- and postoperative complications. Consequently, these patients often suffer from a delayed or limited recovery, loss of autonomy and quality of life, and a decrease in functional and cognitive capacities. Since frailty is modifiable, prehabilitation may improve the physiological reserves of patients and reduce the care dependency 12 months after surgery.
Patients ≥ 70 years old scheduled for elective surgery or intervention will be recruited in this multicenter, randomized controlled study, with a target of 1400 participants with an allocation ratio of 1:1. The intervention consists of (1) a shared decision-making process with the patient, relatives, and an interdisciplinary and interprofessional team and (2) a 3-week multimodal, individualized prehabilitation program including exercise therapy, nutritional intervention, mobility or balance training, and psychosocial interventions and medical assessment. The frequency of the supervised prehabilitation is 5 times/week for 3 weeks. The primary endpoint is defined as the level of care dependency 12 months after surgery or intervention.
Prehabilitation has been proven to be effective for different populations, including colorectal, transplant, and cardiac surgery patients. In contrast, evidence for prehabilitation in older, frail patients has not been clearly established. To the best of our knowledge, this is currently the largest prehabilitation study on older people with frailty undergoing general elective surgery.
ClinicalTrials.gov NCT04418271 . Registered on 5 June 2020. Universal Trial Number (UTN): U1111-1253-4820.
虚弱表现为身体能力、活动能力、肌肉力量和耐力的下降。（术前）虚弱存在于高达 42%的老年手术人群中，围手术期和术后并发症的风险增加。因此，这些患者往往恢复缓慢或受限，失去自主性和生活质量，身体和认知功能下降。由于虚弱是可改变的，术前康复可以提高患者的生理储备，减少术后 12 个月的护理依赖。
本研究为多中心、随机对照研究，将招募≥70 岁择期手术或介入治疗的患者，目标人群为 1400 例，分配比例为 1:1。干预措施包括（1）与患者、家属以及跨学科和多专业团队进行共同决策，（2）为期 3 周的多模式个体化术前康复计划，包括运动治疗、营养干预、活动或平衡训练以及心理社会干预和医学评估。监督下的术前康复频率为每周 5 次，共 3 周。主要终点定义为术后或介入治疗后 12 个月的护理依赖水平。
术前康复已被证明对不同人群有效，包括结直肠、移植和心脏手术患者。相比之下，术前康复在老年虚弱患者中的证据尚未明确。据我们所知，这是目前针对接受普通择期手术的老年虚弱患者进行的最大规模术前康复研究。
ClinicalTrials.gov NCT04418271。注册于 2020 年 6 月 5 日。通用试验编号（UTN）：U1111-1253-4820。
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