Multimodal Prehabilitation in Thoracic Surgery

Study Overview
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Brief Summary
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This trial aims to assess the impact of a multimodal prehabilitation program in high-risk patients undergoing lung resection surgery.

Detailed Description
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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.

Official Title
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Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Usual care
* Other: Multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Patients following the standard preoperative policies of opur institution | Other: Usual care<br>* 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.<br>|
| Experimental: Prehabilitation<br>Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program | Other: Multimodal prehabilitation<br>* 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.<br>* Other names: Prehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Hospital days of stay | During initial hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Number and severity of postoperative complications | During initial hospitalization | 
| 30-day hospital readmissions | Hospital readmissions during the first 30 days after surgery | To 30 days after surgery | 
| 30-day emergency room visits | Emergency room visits during the first 30 days after surgery | 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)) | Baseline and pre-surgery | 
| Aerobic capacity | Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer | 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)) | 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)) | 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)) | Baseline and pre-surgery | 
| Fat free mass index | Fat free mass index measured by bioimpedance | Baseline and pre-surgery | 
| PCR | Blood levels of PCR | Baseline and pre-surgery | 
| ultrasensible PCR | Blood levels of ultrasensible PCR | Baseline and pre-surgery | 
| TNF-α | Blood levels of TNF-α | Baseline and pre-surgery | 
| IL-6 | Blood levels of IL-6 | Baseline and pre-surgery | 
| IL-8 | Blood levels of IL-8 | Baseline and pre-surgery | 
| IL-10 | Blood levels of IL-10 | Baseline and pre-surgery | 
| 8-isoprostane | Blood levels of 8-isoprostane | Baseline and pre-surgery | 
| fibrinogen | Blood levels of fibrinogen | Baseline and pre-surgery | 
| leptin | Blood levels of leptin | Baseline and pre-surgery | 
| adiponectin | Blood levels of adiponectin | Baseline and pre-surgery | 
| white cells | Blood levels of white cells | Baseline and pre-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehabilitation, Exercise training, Physical activity, Nutrition, Cognitive behavioural therapy, Smoking cessation