Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Hospital length of stay
研究概览
简要总结
This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.
详细描述
This trial aims to assess the cost-effectiveness of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery. Secondary objectives are to evaluate the impact of the intervention on: i) Healthcare resuorces use; ii) clinical outcomes; and, iii) patient's and professionals experience with the program.
The program includes X main interventions: i) A motivational interview; ii) A high-intensity exercise training program; iii) A plan for physical activity incentivation; iv) A nutritional optimization program; v) A psicologichal support program; and, vi) A smoking cessation program.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forced espiratory volume in the first second (FEV1) and/or estimated postoperative lung diffusion capacity for carbon monoxide < 60%; and/or,
- •American Society of Anesthesiologist (ASA) index 3-4; and/or,
- •Peak oxygen uptake among 10-20 mL/kg/min.
排除标准
- •Non-elective surgery;
- •Metastasic disease;
- •Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
结局指标
主要结局
Hospital length of stay
时间窗: During initial hospitalization
Hospital days of stay
次要结局
- IL-8(Baseline and pre-surgery)
- fibrinogen(Baseline and pre-surgery)
- white cells(Baseline and pre-surgery)
- Postoperative complications(During initial hospitalization)
- 30-day hospital readmissions(To 30 days after surgery)
- Self-perceived physical status(Baseline and pre-surgery)
- Psychological status(Baseline and pre-surgery)
- Fat free mass index(Baseline and pre-surgery)
- PCR(Baseline and pre-surgery)
- ultrasensible PCR(Baseline and pre-surgery)
- TNF-α(Baseline and pre-surgery)
- IL-10(Baseline and pre-surgery)
- 8-isoprostane(Baseline and pre-surgery)
- 30-day emergency room visits(To 30 days after surgery)
- Physical activity(Baseline and pre-surgery)
- Aerobic capacity(Baseline and pre-surgery)
- Self-perceived mental status(Baseline and pre-surgery)
- IL-6(Baseline and pre-surgery)
- leptin(Baseline and pre-surgery)
- adiponectin(Baseline and pre-surgery)
研究者
Anael Barberan-Garcia
Principal investigator
Hospital Clinic of Barcelona