Lung Cancer
Conditions
Keywords
Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation
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.
Interventions
OTHERUsual care
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.
OTHERMultimodal prehabilitation
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.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Forced espiratory volume in the first second (FEV1) and/or estimated postoperative lung diffusion capacity for carbon monoxide \< 60%; and/or, 2. American Society of Anesthesiologist (ASA) index 3-4; and/or, 3. Peak oxygen uptake among 10-20 mL/kg/min.
Exclusion criteria
1. Non-elective surgery; 2. Metastasic disease; 3. Unestable cardiac or respiratory condition; 4) Cognitive or locomotor limitations precluding the adherence to the program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | During initial hospitalization | Hospital days of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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)) |
| 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)) |
| 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)) |
| 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 |
| Aerobic capacity | Baseline and pre-surgery | Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer |
| TNF-α | Baseline and pre-surgery | Blood levels of TNF-α |
| IL-6 | Baseline and pre-surgery | Blood levels of IL-6 |
| IL-8 | Baseline and pre-surgery | Blood levels of IL-8 |
| IL-10 | Baseline and pre-surgery | Blood levels of IL-10 |
| 8-isoprostane | Baseline and pre-surgery | Blood levels of 8-isoprostane |
| fibrinogen | Baseline and pre-surgery | Blood levels of fibrinogen |
| leptin | Baseline and pre-surgery | Blood levels of leptin |
| adiponectin | Baseline and pre-surgery | Blood levels of adiponectin |
| white cells | Baseline and pre-surgery | Blood levels of white cells |
| ultrasensible PCR | Baseline and pre-surgery | Blood levels of ultrasensible PCR |
Countries
Spain
Contacts
Primary ContactMaria Sanchez
Outcome results
None listed