Multimodal Prehabilitation in Thoracic Surgery

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Lung Cancer

Treatments: Other: Multimodal prehabilitation; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04052100

HCB/2018/1138

Details and patient eligibility

About

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

Full 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.

Enrollment: 158 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Patients following the standard preoperative policies of opur institution

Treatment:

Other: Usual care

Prehabilitation

Experimental group

Description:

Patients following the standard preoperative policies of opur institution and the multimodal prehabilitation program

Treatment:

Other: Multimodal prehabilitation