RecruitingNot ApplicableNCT06732193

Fissios© and Postoperative Complications (FPoC Trial)

Clinical Trial Comparing a Face-to-face Perioperative Respiratory Physiotherapy Program Versus the Use of Fissios App© as a Complement to a Respiratory Physiotherapy Program in Patients Diagnosed With NSCLC Undergoing Surgery.


Sponsor

Carlos Alfredo Fraile Olivero, MD, PhD.

Enrollment

560 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Respiratory physiotherapy as part of a pre-operative physical training program may reduce the risk of developing post-operative complications, improving post-operative results and optimizing physical conditions in patients with a diagnosis of non-small cell lung cancer (NSCLC) undergoing lung resection surgery. During the post-operative period, performing physical exercise has also been proved to increase the capacity for exercise, improve health-related quality of life and reduce the feeling of breathlessness. Fissios App is a tool created by thoracic surgeons, physiotherapists and a specialist doctor in physical medicine and rehabilitation, which has been satisfactorily implemented in thoracic surgery patients; this contains a program of standardized respiratory physiotherapy exercises with a defined time and number of repetitions. The aim is to compare the effectiveness of use of the Fissios App tool as a complement to a peri-operative respiratory physiotherapy program compared to just attendance at a face-to-face peri-operative respiratory physiotherapy program, to reduce the incidence of post-operative complications. It is expected to include 560 patients in the study. Subsequent to evaluation by the investigator and the acceptance of participant to take part in the study, the performing of peri-operative respiratory physiotherapy is prescribed. The participants will be randomly assigned to a study group that uses the tool as a complement to the respiratory physiotherapy program or a control group that should only attend face-to-face respiratory physiotherapy sessions. All the participants should attend face-to-face respiratory physiotherapy classes taught by physiotherapists at the place and time set out in each centre before and after surgery for at least 45 minutes and at least five sessions. Moreover, study group participants may use the Fissios App tool. Investigators should fill in the pre-operative, surgery and post-operative data for each patient on the Fissios Research platform.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the Fissios app — a smartphone-based breathing exercise program — to see if it helps patients recover from lung surgery for suspected or confirmed lung cancer and reduces post-surgical complications such as breathing problems. **You may be eligible if...** - You are over 18 years old - You are scheduled for lung removal surgery (segmentectomy, lobectomy, or pneumonectomy) due to suspected or confirmed non-small cell lung cancer - You have a compatible smartphone and the ability (or support) to use it - You are willing to participate and complete the study procedures **You may NOT be eligible if...** - There is a medical reason you should not do breathing physiotherapy exercises - You do not have a compatible smartphone - You are unable to give informed consent or follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOn-site respiratory physiotherapy

The patient attends face-to-face physiotherapy sessions prescribed by the doctor.

DEVICEFissios App

The patient uses the Fissios App to perform respiratory physiotherapy exercises.


Locations(1)

Hospital Clínico San Carlos

Madrid, Madrid, Spain

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NCT06732193


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