Multimodal Prehabilitation in Thoracic Surgery
- Conditions
- Lung Cancer
- Interventions
- Other: Usual careOther: Multimodal prehabilitation
- Registration Number
- NCT04052100
- Lead Sponsor
- Hospital Clinic of Barcelona
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 158
- 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.
- Non-elective surgery;
- Metastasic disease;
- Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care Usual care Patients following the standard preoperative policies of opur institution Prehabilitation Multimodal prehabilitation Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program
- Primary Outcome Measures
Name Time Method Hospital length of stay During initial hospitalization Hospital days of stay
- Secondary Outcome Measures
Name Time Method TNF-α Baseline and pre-surgery Blood levels of TNF-α
IL-10 Baseline and pre-surgery Blood levels of IL-10
8-isoprostane Baseline and pre-surgery Blood levels of 8-isoprostane
Self-perceived physical status Baseline and pre-surgery Physical status measured by the physical domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))
Psychological status Baseline and pre-surgery Anxiety and depression levels measured by the Hospital Anxiety and Depression (HAD) questionnaire (range 0-42 points (the lower, the better))
Fat free mass index Baseline and pre-surgery Fat free mass index measured by bioimpedance
PCR Baseline and pre-surgery Blood levels of PCR
ultrasensible PCR Baseline and pre-surgery Blood levels of ultrasensible PCR
IL-8 Baseline and pre-surgery Blood levels of IL-8
fibrinogen Baseline and pre-surgery Blood levels of fibrinogen
white cells Baseline and pre-surgery Blood levels of white cells
Postoperative complications During initial hospitalization Number and severity of postoperative complications
30-day hospital readmissions To 30 days after surgery Hospital readmissions during the first 30 days after surgery
30-day emergency room visits To 30 days after surgery Emergency room visits during the first 30 days after surgery
Physical activity Baseline and pre-surgery Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))
Aerobic capacity Baseline and pre-surgery Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer
Self-perceived mental status Baseline and pre-surgery Mental status measured by the mental domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))
IL-6 Baseline and pre-surgery Blood levels of IL-6
leptin Baseline and pre-surgery Blood levels of leptin
adiponectin Baseline and pre-surgery Blood levels of adiponectin
Trial Locations
- Locations (1)
Hospital Clínic de Barcelona
🇪🇸Barcelona, Catalonia, Spain