跳至主要内容
临床试验/NCT02024776
NCT02024776已完成不适用

The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
2
主要终点
The incidence of postoperative complications, classified by Clavien Scale

研究概览

简要总结

Despite recent advances, morbidity and mortality associated to major abdominal surgery is significant. A poor physical condition and functional status reduces the ability of a person to cope, mentally and physically, with hospitalization and surgery and may compromise functional recovery, potentially leading to postoperative complications and death. Prehabilitation aims to enhance functional capacity preoperatively for better toleration of surgery and to facilitate recovery and eventually the prognosis of the surgical patient. Whereas the benefits of cardiopulmonary fitness programs are well established, the accessibility, sustainability of effects, and impact on the surgical outcome of these programs are unsolved issues. Wellness programs based on integrated care services supported by Information and Communication Technology (ICT) can overcome such limitations. The investigators hypothesized that a prehabilitation program, inducing beneficial effects on exercise capacity, may improve the surgical outcome in high-risk patients. Moreover, ICT support may contribute to increase the adherence and sustainability of this intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 70 years-old and/or American Society of Anesthesiologists (ASA) health status class III-IV, with a DASI (Duke Activity Score Index) <46 points, referred for scheduled major abdominal surgery

排除标准

  • Unstable severe co-morbid disease
  • Dementia and psychosis, severe mental disorder or substance abuse or dependence
  • Disabling orthopedic and neuromuscular disease.

结局指标

主要结局

The incidence of postoperative complications, classified by Clavien Scale

时间窗: Time Frame: 30days or the postoperative hospital stay if longer than 30 days

次要结局

  • Length of stay(30 days or the postoperative hospital stay if longer than 30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Graciela Martinez-Palli

MD, PhD

Hospital Clinic of Barcelona

研究点 (2)

Loading locations...

相似试验