Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Perioperative Care | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
| Surgery Scheduled | — | UNRESOLVED | — |
| Surgical Procedure, Unspecified | — | UNRESOLVED | — |
| Thoracic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fissios App | Device | — | UNRESOLVED |
| On-site respiratory physiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- In-person respiratory physiotherapy
- description
- The patient must attend the respiratory physiotherapy sessions given by physiotherapists at the place and time established in each centre, before and after surgery.
- interventionNames
- Procedure: On-site respiratory physiotherapy
- type
- EXPERIMENTAL
- label
- Face-to-face respiratory physiotherapy plus use of the Fissios App
- description
- 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.
- interventionNames
- Procedure: On-site respiratory physiotherapy
- Device: Fissios App
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (13)
- RESULTRami-Porta R, Wittekind C, Goldstraw P; International Association for the Study of Lung Cancer (IASLC) Staging Committee. Complete resection in lung cancer surgery: proposed definition. Lung Cancer. 2005 Jul;49(1):25-33. doi: 10.1016/j.lungcan.2005.01.001. PMID 15949587
- RESULTFernandez FG, Falcoz PE, Kozower BD, Salati M, Wright CD, Brunelli A. The Society of Thoracic Surgeons and the European Society of Thoracic Surgeons general thoracic surgery databases: joint standardization of variable definitions and terminology. Ann Thorac Surg. 2015 Jan;99(1):368-76. doi: 10.1016/j.athoracsur.2014.05.104. PMID 25555970
- RESULTGarutti I, Cabanero A, Vicente R, Sanchez D, Granell M, Fraile CA, Real Navacerrada M, Novoa N, Sanchez-Pedrosa G, Congregado M, Gomez A, Minana E, Pineiro P, Cruz P, de la Gala F, Quero F, Huerta LJ, Rodriguez M, Jimenez E, Puente-Maestu L, Aragon S, Osorio-Salazar E, Sitges M, Lopez Maldonado MD, Rios FT, Morales JE, Callejas R, Gonzalez-Bardancas S, Botella S, Cortes M, Yepes MJ, Iranzo R, Sayas J. Recommendations of the Society of Thoracic Surgery and the Section of Cardiothoracic and Vascular Surgery of the Spanish Society of Anesthesia, Resuscitation and Pain Therapy, for patients undergoing lung surgery included in an intensified recovery program. Rev Esp Anestesiol Reanim (Engl Ed). 2022 Apr;69(4):208-241. doi: 10.1016/j.redare.2021.02.011. Epub 2022 May 15. PMID 35585017
- RESULTBatchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301. PMID 30304509
- RESULTFraile Olivero CA, Jarabo Sarceda JR, Fernandez Martin E, Santos Capa P, Arribas Manzanal PD, Gomez Martinez AM, Calatayud Gastardi J, Hernando Trancho F. Implementation of a perioperative care App in elective thoracic surgery. Cir Esp (Engl Ed). 2023 Apr;101(4):265-273. doi: 10.1016/j.cireng.2022.09.022. Epub 2022 Sep 12.