The Effectiveness of Tailored Physical Training Intervention (Prehabilitation) in High-risk Patients Underwent Major Abdominal Surgery on Postoperative Complications: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 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
- 否
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.
研究组 & 干预措施
Prehabilitation
Prehabilitation program is defined as a tailored physical exercise program to be carried out to a patient on the basis of his/her health condition, social circumstances and adherence profile. The intervention consisted of a standard 4-6 week supervised outpatient program including global endurance exercise training, or educational sessions followed by a self-management program supported by ICT during the follow-up period, or a combination of both.
干预措施: Prehabilitation (Behavioral)
No-intervention
Standard counseling and conventional pre-surgical measures
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
Graciela Martinez-Palli
MD, PhD
Hospital Clinic of Barcelona
