Multimodal Prehabilitation in Thoracic Surgery

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

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

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Usual care; Other: Multimodal prehabilitation

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 Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Sanchez; Phone Number: +34 932775540; Email: masanchezm@clinic.cat

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • Recruiting
      • Hospital Clínic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Patients following the standard preoperative policies of opur institution	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.
Experimental: Prehabilitation; Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program	Other: 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.; Other Names: Prehabilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Anael Barberan-Garcia, PhD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• Barberan-Garcia A, Navarro-Ripoll R, Sanchez-Lorente D, Moises-Lafuente J, Boada M, Messaggi-Sartor M, Gonzalez-Vallespi L, Montane-Muntane M, Alsina-Restoy X, Campero B, Lopez-Baamonde M, Romano-Andrioni B, Guzman R, Lopez A, Arguis MJ, Roca J, Martinez-Palli G. Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol. BMC Health Serv Res. 2020 Mar 12;20(1):207. doi: 10.1186/s12913-020-05078-9.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Nutrition; Physical activity; Smoking cessation; Exercise training; Cognitive behavioural therapy; Prehabilitation
• Other Study ID Numbers: HCB/2018/1138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No