NCT06732193Recruiting
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.
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 560 (estimated)
- First submitted
- 25 Nov 2024
- Start date
- 20 Mar 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Carlos Alfredo Fraile Olivero, MD, PhD.
- Diseases
- Lung cancer
- NCT number
- NCT06732193
What you commit to
- Study type: Interventional
- Planned participants: 560
- From 20 Mar 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Medical contraindication to perform respiratory physiotherapy exercises.
- Not possessing a smart mobile device compatible with Fissios App©.
- Inability of the patient to perform the exercises, either due to a physical or psychological impediment.
- Inability to complete the informed consent form for participation in the study.
- Refusal to participate in the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
Related publications
- Fissios and postoperative complications (FPoC trial): a multicentre, randomised, controlled clinical trial.BMJ Open Respir Res · 2026 · PMID 42303312
This page is information, not medical advice. Discuss any trial with your doctor.