Multimodal Prehabilitation in Thoracic Surgery

Not Applicable

• Conditions: Lung Cancer

• 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.

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Study Start: 2019-10-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	During initial hospitalization	Hospital days of stay

Secondary Outcome Measures

Name	Time	Method
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
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
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
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