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临床试验/NCT03466606
NCT03466606已完成不适用

Implementation of a Trimodal Prehabilitation Program as a Preoperative Optimization Strategy in Cardiac Surgery

Hospital Clinic of Barcelona3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年3月5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
200
试验地点
3
主要终点
The incidence of postoperative complications graded by Clavien Dindo classification.

研究概览

简要总结

Pre-habilitation programs that combine physical training, nutritional support and emotional reinforcement have demonstrated efficacy as presurgical optimization strategies in the context of digestive surgery. The experience in patients at risk for cardiac surgery, one of those associated with higher morbidity and mortality, is anecdotal. Main objective: to evaluate the feasibility, efficacy and cost-effectiveness of a pre-habilitation program for the improvement of preoperative functional capacity in high-risk and intermediate risk groups for cardiac surgery and its impact on the reduction of postoperative complications (primary endpoint). Secondary objectives: (i) in-hospital stay; (ii) symptoms, quality of life, (iii) evaluation of information and communication technologies (ICT) as a support for the pre-habilitation, and (iv) design and validation of indicators for a future large-scale implementation of this type of intervention.

Design: Subproject: #1: Prospective study of the efficacy of prehabilitation in heart transplant candidates during the study period. The results will be compared with historical records; #2: Randomized controlled trial with a 1:1 ratio to assess the efficacy of prehabilitation in patients undergoing elective coronary revascularization or valve replacement surgery. Subjects: Subproject #1: 40 patients candidates for heart transplantation. Subproject #2: 80 patients in the prehabilitation group and 80 controls in which a conventional treatment will be performed. Intervention: (i) personalized supervised resistance training, and (ii) program to promote physical activity and healthy lifestyles. The overall duration of the intervention is estimated to be at least 4-6 weeks (variable in each subproject). The support with ICTs will be a significant aspect of the program in which the adaptation of the personal health folder of Catalonia (Cat@SalutLaMevaSalut) will be fundamental.

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

  • Subproject #1: Heart transplant candidates
  • Subproject #2: Patients awaiting for coronary artery bypass or valve surgery with an expected waiting time for surgery of 8-12 weeks

排除标准

  • Dynamic left ventricular outflow tract obstruction (> 40 mmHg)
  • Arrythmia induced by exercise
  • Emergent surgery
  • Unstable cardiac disease
  • Unstable severe co-morbid disease
  • Disabling orthopedic and neuromuscular disease
  • Cognitive impairment
  • Refusal to participate in the study

结局指标

主要结局

The incidence of postoperative complications graded by Clavien Dindo classification.

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

The classification's basic principle is to grade complications according to the treatment that is induced to treat the complication. It consists of 5 grades with 2 grades being further subdivided.

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

Head of Anesthesia Department

Hospital Clinic of Barcelona

研究点 (3)

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