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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients over 18 years of age.

• Indication for lung resection surgery due to diagnostic suspicion or histopathological diagnosis of non-small cell lung carcinoma.

• Anatomical lung resection surgery: anatomical segmental resection, lobectomies or pneumonectomies, using a conventional or minimally invasive approach (VATS, RATS).

• The patient has a smart mobile device compatible with the Fissios App©, has the ability or has the support to use it.

• Willingness and commitment to participate in the study.

• Ability to complete the informed consent to participate in the study.

Locations
Other Locations
Spain
Hospital Clínico San Carlos
RECRUITING
Madrid
Contact Information
Primary
Carlos A Fraile Olivero, MD, PhD
carlosalfredo.fraile@salud.madrid.org
+34917043708
Backup
Lidia Sotillo, MD
lidia.sotillo@salud.madrid.org
+34917043717
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 560
Treatments
Active_comparator: In-person respiratory physiotherapy
The patient must attend the respiratory physiotherapy sessions given by physiotherapists at the place and time established in each centre, before and after surgery.
Experimental: Face-to-face respiratory physiotherapy plus use of the Fissios App
The same protocol will be followed as for the control group and, in addition, the steps for downloading the application and the start-up will be explained verbally and in writing. The researcher will encourage the patient to use the Fissios App©, read all the perioperative medical recommendations and perform the respiratory physiotherapy exercises freely without restrictions in terms of time, time of use or location.
Sponsors
Collaborators: Spanish Society of Thoracic Surgery (SECT), Spanish Society of Pneumology and Thoracic Surgery (SEPAR), Asociación Española de Afectados de Cáncer de Pulmón (AEACaP), Medtronic General Research Grant
Leads: Carlos Alfredo Fraile Olivero, MD, PhD.

This content was sourced from clinicaltrials.gov