Fissios© and Postoperative Complications (FPoC Trial) (FPoC)

September 10, 2025 updated by: Carlos Alfredo Fraile Olivero, MD, PhD.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The FPoC Trial is designed as a multicentre, prospective, randomised, prospective, parallel, two-group, controlled, open-label, superiority study of only face-to-face respiratory physiotherapy or the use of Fissios App© as an adjunct to respiratory physiotherapy in patients scheduled for lung resection surgery.

The participants who take part in the study will be randomly assigned to the study or control group before the surgical procedure. All of them will follow an in-person respiratory physiotherapy programme, and the study group will complement this programme with the use of the Fissios App tool.

Perioperative care will be carried out in accordance with national and international guidelines. Postoperative complications will be recorded following the established definitions of the European Society of Thoracic Surgeons (ESTS) database and in the study protocol.

Finally, all the participants will be followed up for 90 days after the date of surgery to finalise the present study. The participants will continue the revisions following the protocols of each centre.

An estimated total of 560 particpants (280 per group) will be recruited for this study.

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos
        • Contact:
        • Principal Investigator:
          • Carlos Alfredo Fraile Olivero, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients over 18 years of age.
  2. Indication for lung resection surgery due to diagnostic suspicion or histopathological diagnosis of non-small cell lung carcinoma.
  3. Anatomical lung resection surgery: anatomical segmental resection, lobectomies or pneumonectomies, using a conventional or minimally invasive approach (VATS, RATS).
  4. The patient has a smart mobile device compatible with the Fissios App©, has the ability or has the support to use it.
  5. Willingness and commitment to participate in the study.
  6. Ability to complete the informed consent to participate in the study.

Exclusion Criteria:

  1. Medical contraindication to perform respiratory physiotherapy exercises.
  2. Not possessing a smart mobile device compatible with Fissios App©.
  3. Inability of the patient to perform the exercises, either due to a physical or psychological impediment.
  4. Inability to complete the informed consent form for participation in the study.
  5. Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: On-site respiratory physiotherapy
The patient attends face-to-face physiotherapy sessions prescribed by the doctor.
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.
Procedure: On-site respiratory physiotherapy
The patient attends face-to-face physiotherapy sessions prescribed by the doctor.
Device: Fissios App
The patient uses the Fissios App to perform respiratory physiotherapy exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Through postoperative evolution, an average of 2 weeks.
Development of at least one adverse clinical event categorised as a postoperative complication during hospital admission. Immediately after the surgery until discharge.
Through postoperative evolution, an average of 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of pleural drainage
Time Frame: Through postoperative evolution, an average of 2 weeks.
Time that the patient has pleural drainage from the end of surgery until medical discharge.
Through postoperative evolution, an average of 2 weeks.
Mortality
Time Frame: During hospitalization period, an average of 2 weeks.
Patient status at the moment of discharge.
During hospitalization period, an average of 2 weeks.
Hospital readmission
Time Frame: Within 30 days of discharge from hospital
Any clinical situation requiring hospital admission
Within 30 days of discharge from hospital
Mortality
Time Frame: During the first 30 days after surgery
During the first 30 days after surgery
Mortality
Time Frame: During the first 90 days after surgery
During the first 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos Alfredo Fraile Olivero, MD, PhD.

Collaborators

Spanish Society of Pneumology and Thoracic Surgery (SEPAR)
Asociación Española de Afectados de Cáncer de Pulmón (AEACaP)
Medtronic General Research Grant
Spanish Society of Thoracic Surgery (SECT)

Investigators

  • Principal Investigator: Carlos A Fraile Olivero, MD, PhD, Hospital San Carlos, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/310-EC_X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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