This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
158
The standard preoperative measures will consist of a recommendation for physical activity and advice on tobacco smoking cessation and reduction of alcohol intake. In addition, patients who suffer from iron deficient anemia will receive intravenous iron and those at risk of malnutrition (Malnutrition Universal Screening Tool ≥2 (www.bapen.org.uk/pdfs/must/must\_full.pdf)) or that require weight control for obesity (IMC≥30) will perform a nutrition intervention by a nutritionist.
The experimental group will also carry out a prehabilitation program consisting in: A. A motivational interview to reinforce the patient's motivation and generate a commitment in relation to the objectives of the program. B. A physical activity promotion program to increase the number of daily steps of patients, measured by a wristband and a mobile App. C. A supervised high-intensity exercise training program. D. An individualized nutritional optimization plan with dietary advice and protein supplementation (if necessary). Educational material and motivational messages will be sent through a mobile App. F. Psychological support through weekly Mindfulness sessions (1.5 hours duration). Educational material and motivational messages will be sent through a mobile App. E. A smoking cessation program consisting psycho-cognitive therapy combined with pharmacological treatment. Educational material and motivational messages will be sent through a mobile App.
Hospital Clínic de Barcelona
Barcelona, Catalonia, Spain
RECRUITINGHospital length of stay
Hospital days of stay
Time frame: During initial hospitalization
Postoperative complications
Number and severity of postoperative complications
Time frame: During initial hospitalization
30-day hospital readmissions
Hospital readmissions during the first 30 days after surgery
Time frame: To 30 days after surgery
30-day emergency room visits
Emergency room visits during the first 30 days after surgery
Time frame: To 30 days after surgery
Physical activity
Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))
Time frame: Baseline and pre-surgery
Aerobic capacity
Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer
Time frame: Baseline and pre-surgery
Self-perceived physical status
Physical status measured by the physical domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))
Time frame: Baseline and pre-surgery
Self-perceived mental status
Mental status measured by the mental domain of the SF-36 questionnaire (range 0-100 points (the higher, the better))
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Time frame: Baseline and pre-surgery
Psychological status
Anxiety and depression levels measured by the Hospital Anxiety and Depression (HAD) questionnaire (range 0-42 points (the lower, the better))
Time frame: Baseline and pre-surgery
Fat free mass index
Fat free mass index measured by bioimpedance
Time frame: Baseline and pre-surgery
PCR
Blood levels of PCR
Time frame: Baseline and pre-surgery
ultrasensible PCR
Blood levels of ultrasensible PCR
Time frame: Baseline and pre-surgery
TNF-α
Blood levels of TNF-α
Time frame: Baseline and pre-surgery
IL-6
Blood levels of IL-6
Time frame: Baseline and pre-surgery
IL-8
Blood levels of IL-8
Time frame: Baseline and pre-surgery
IL-10
Blood levels of IL-10
Time frame: Baseline and pre-surgery
8-isoprostane
Blood levels of 8-isoprostane
Time frame: Baseline and pre-surgery
fibrinogen
Blood levels of fibrinogen
Time frame: Baseline and pre-surgery
leptin
Blood levels of leptin
Time frame: Baseline and pre-surgery
adiponectin
Blood levels of adiponectin
Time frame: Baseline and pre-surgery
white cells
Blood levels of white cells
Time frame: Baseline and pre-surgery