NCT06732193: FPoC

Fissios© and Postoperative Complications (FPoC Trial)

Recruiting now NA Last updated 11 September 2025

What this trial tests

NA trial testing On-site respiratory physiotherapy in Surgical Procedure, Unspecified in 560 participants. Currently enrolling.

Timeline

20 March 2025

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Carlos Alfredo Fraile Olivero, MD, PhD.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	560
Start date	20 March 2025
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Spain

Drugs / interventions tested

• On-site respiratory physiotherapy
• Fissios App

Conditions studied

• Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →
• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Surgery Scheduled — all drugs for Surgery Scheduled →
• Thoracic Surgery — all drugs for Thoracic Surgery →

Sponsor

Carlos Alfredo Fraile Olivero, MD, PhD.

Who can join

18 and older, any sex, with Surgical Procedure, Unspecified or Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.