Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06732193

Clinical Trial Comparing Face-to-face Perioperative Respiratory Physiotherapy Versus Use of Fissios App as Complement in Patients With NSCLC Undergoing Surgery

Led by Carlos Alfredo Fraile Olivero, MD, PhD. · Updated on 2025-09-11

560

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Carlos Alfredo Fraile Olivero, MD, PhD.

Lead Sponsor

S

Spanish Society of Pneumology and Thoracic Surgery (SEPAR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying respiratory physiotherapy as part of a physical training program before and after lung resection surgery in patients with non-small cell lung cancer (NSCLC). The goal is to see if using the Fissios App alongside face-to-face respiratory physiotherapy reduces post-operative complications compared to face-to-face physiotherapy alone. This study is a multicenter, randomized, open-label trial with two groups, aiming to improve post-operative outcomes and physical condition. Participants will be randomly assigned to either receive only face-to-face respiratory physiotherapy sessions or to receive these sessions plus use the Fissios App, which provides guided respiratory exercises. All participants must attend at least five in-person physiotherapy sessions before and after surgery, each lasting at least 45 minutes. The study group will be encouraged to use the Fissios App freely at any time and place. Lung surgeries include segmental resection, lobectomy, or pneumonectomy, performed either conventionally or minimally invasively. During the study, researchers will collect pre-operative, surgical, and post-operative data on the Fissios Research platform. Patients will be followed for 90 days after surgery to monitor complications, length of drainage, mortality, and hospital readmissions. The trial includes detailed recording of post-operative outcomes using standardized definitions and aims to recruit around 560 participants in total.

CONDITIONS

Brief Title

Fissios© and Postoperative Complications (FPoC Trial)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Indication for lung resection surgery due to suspicion or diagnosis of non-small cell lung carcinoma
  • Undergoing anatomical lung resection surgery including segmental resection, lobectomies, or pneumonectomies by conventional or minimally invasive methods
  • Possession of a compatible smart mobile device and ability or support to use the Fissios App
  • Willingness and commitment to participate in the study
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Medical reasons preventing respiratory physiotherapy exercises
  • Lack of a compatible smart mobile device for the Fissios App
  • Inability to perform exercises due to physical or psychological reasons
  • Unable to complete informed consent
  • Refusal to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - Pre-surgery period as per centre protocol

Participants are randomly assigned to either face-to-face respiratory physiotherapy alone or face-to-face respiratory physiotherapy plus the use of the Fissios App before surgery.

Multiple visits depending on centre schedule

Surgery and Immediate Post-operative Care

Duration - Hospitalization period (approximately 2 weeks)

Participants undergo lung resection surgery and receive perioperative care according to national and international guidelines.

Hospital visits during hospitalization

Post-operative Follow-up

Duration - Up to 90 days after surgery

Participants continue respiratory physiotherapy sessions and, if assigned, use the Fissios App. Postoperative complications are monitored and recorded following established definitions.

Follow-up visits according to centre protocols

Trial Site Locations

Total: 1 location

1

Hospital Clínico San Carlos

Madrid, Madrid, Spain, 28040

Actively Recruiting

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Research Team

C

Carlos A Fraile Olivero, MD, PhD

L

Lidia Sotillo, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

The Society of Thoracic Surgeons and the European Society of Thoracic Surgeons general thoracic surgery databases: joint standardization of variable definitions and terminology.

Felix G Fernandez, Pierre E Falcoz, Benjamin D Kozower...

https://pubmed.ncbi.nlm.nih.gov/25555970

Recommendations of the Society of Thoracic Surgery and the Section of Cardiothoracic and Vascular Surgery of the Spanish Society of Anesthesia, Resuscitation and Pain Therapy, for patients undergoing lung surgery included in an intensified recovery program.

I Garutti, A Cabañero, R Vicente...

https://pubmed.ncbi.nlm.nih.gov/35585017

Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS®) Society and the European Society of Thoracic Surgeons (ESTS).

Timothy J P Batchelor, Neil J Rasburn, Etienne Abdelnour-Berchtold...

https://pubmed.ncbi.nlm.nih.gov/30304509

Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer.

Ilem D Rosero, Robinson Ramírez-Vélez, Alejando Lucia...

https://pubmed.ncbi.nlm.nih.gov/31284372

Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence?

Carlotta Mainini, Patrícia Fs Rebelo, Roberta Bardelli...

https://pubmed.ncbi.nlm.nih.gov/27803808

Postoperative outcomes following preoperative inspiratory muscle training in patients undergoing cardiothoracic or upper abdominal surgery: a systematic review and meta analysis.

Christina M Mans, Julie C Reeve, Mark R Elkins

https://pubmed.ncbi.nlm.nih.gov/25160007

Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis.

Filipa Kendall, José Oliveira, Bárbara Peleteiro...

https://pubmed.ncbi.nlm.nih.gov/28093920

Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer.

Vinicius Cavalheri, Chris Burtin, Vittoria R Formico...

https://pubmed.ncbi.nlm.nih.gov/31204439