Multimodal Prehabilitation in Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04052100
• Other study ID #: HCB/2018/1138
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Hospital Clinic of Barcelona
• Contact: Maria Sanchez
• Phone: +34 932775540
• Email: masanchezm[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• Usual 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.
• Multimodal 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.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	Hospital days of stay	During initial hospitalization
Secondary	Postoperative complications	Number and severity of postoperative complications	During initial hospitalization
Secondary	30-day hospital readmissions	Hospital readmissions during the first 30 days after surgery	To 30 days after surgery
Secondary	30-day emergency room visits	Emergency room visits during the first 30 days after surgery	To 30 days after surgery
Secondary	Physical activity	Physical activity measured by the Yale Physical Activity Survey (YPAS) (range 0-126 points (the higher, the better))	Baseline and pre-surgery
Secondary	Aerobic capacity	Exercise endurance time achieved in a constant work-rate exercise test in cycle-ergometer	Baseline and pre-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Fat free mass index	Fat free mass index measured by bioimpedance	Baseline and pre-surgery
Secondary	PCR	Blood levels of PCR	Baseline and pre-surgery
Secondary	ultrasensible PCR	Blood levels of ultrasensible PCR	Baseline and pre-surgery
Secondary	TNF-a	Blood levels of TNF-a	Baseline and pre-surgery
Secondary	IL-6	Blood levels of IL-6	Baseline and pre-surgery
Secondary	IL-8	Blood levels of IL-8	Baseline and pre-surgery
Secondary	IL-10	Blood levels of IL-10	Baseline and pre-surgery
Secondary	8-isoprostane	Blood levels of 8-isoprostane	Baseline and pre-surgery
Secondary	fibrinogen	Blood levels of fibrinogen	Baseline and pre-surgery
Secondary	leptin	Blood levels of leptin	Baseline and pre-surgery
Secondary	adiponectin	Blood levels of adiponectin	Baseline and pre-surgery
Secondary	white cells	Blood levels of white cells	Baseline and pre-surgery