Clinical trial NCT04052100: Multimodal Prehabilitation in Thoracic Surgery
Official title: Cost-effectiveness of a Multimodal Prehabilitation Program in High-risk Patients Undergoing to Lung Resection: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Prehabilitation
Exercise training
Physical activity
Nutrition
Cognitive behavioural therapy
Smoking cessation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital length of stay
timeFrame: During initial hospitalization
Secondary outcomes:
measure: Postoperative complications
timeFrame: During initial hospitalization
measure: 30-day hospital readmissions
timeFrame: To 30 days after surgery
measure: 30-day emergency room visits
timeFrame: To 30 days after surgery
measure: Physical activity
timeFrame: Baseline and pre-surgery
measure: Aerobic capacity
timeFrame: Baseline and pre-surgery
measure: Self-perceived physical status
timeFrame: Baseline and pre-surgery
measure: Self-perceived mental status
timeFrame: Baseline and pre-surgery
measure: Psychological status
timeFrame: Baseline and pre-surgery
measure: Fat free mass index
timeFrame: Baseline and pre-surgery
measure: PCR
timeFrame: Baseline and pre-surgery
measure: ultrasensible PCR
timeFrame: Baseline and pre-surgery
measure: TNF-α
timeFrame: Baseline and pre-surgery
measure: IL-6
timeFrame: Baseline and pre-surgery
measure: IL-8
timeFrame: Baseline and pre-surgery
measure: IL-10
timeFrame: Baseline and pre-surgery
measure: 8-isoprostane
timeFrame: Baseline and pre-surgery
measure: fibrinogen
timeFrame: Baseline and pre-surgery
measure: leptin
timeFrame: Baseline and pre-surgery
measure: adiponectin
timeFrame: Baseline and pre-surgery
measure: white cells
timeFrame: Baseline and pre-surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalonia
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Anael Barberan-Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.