Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Hospital length of stay
- Last Updated
- 6 years ago
Overview
Brief Summary
This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.
Detailed Description
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.
Investigators
Anael Barberan-Garcia
Principal investigator
Hospital Clinic of Barcelona
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Non-elective surgery;
- •Metastasic disease;
- •Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
Outcomes
Primary Outcomes
Hospital length of stay
Time Frame: During initial hospitalization
Hospital days of stay
Secondary Outcomes
- 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)