Fissios© and Postoperative Complications (FPoC Trial)

NCT06732193 | Recruiting

• 1 other identifier: 22/310-EC_X
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Procedure, Unspecified; Non Small Cell Lung Cancer; Surgery Scheduled; Thoracic Surgery; Postoperative Complications; Perioperative Care

Keywords

Respiratory physiotherapy; Smartphone App; Post-operative complications; Peri-operative physical training

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  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 Outcomes (5)

• Duration of pleural drainage

  Through postoperative evolution, an average of 2 weeks.

• Mortality

  During hospitalization period, an average of 2 weeks.

• Hospital readmission

  Within 30 days of discharge from hospital

• Mortality

  During the first 30 days after surgery

• Mortality

  During the first 90 days after surgery

Study Arms (2)

In-person respiratory physiotherapy

ACTIVE COMPARATOR

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

Face-to-face respiratory physiotherapy plus use of the Fissios App

EXPERIMENTAL

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; Device: Fissios App

Interventions

On-site respiratory physiotherapy PROCEDURE

The patient attends face-to-face physiotherapy sessions prescribed by the doctor.

Face-to-face respiratory physiotherapy plus use of the Fissios App; In-person respiratory physiotherapy

Fissios App DEVICE

The patient uses the Fissios App to perform respiratory physiotherapy exercises.

Face-to-face respiratory physiotherapy plus use of the Fissios App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos Alfredo Fraile Olivero, MD, PhD.: lead
• Spanish Society of Pneumology and Thoracic Surgery (SEPAR): collaborator
• Asociación Española de Afectados de Cáncer de Pulmón (AEACaP): collaborator
• Medtronic General Research Grant: collaborator
• Spanish Society of Thoracic Surgery (SECT): collaborator

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (12)

• Rami-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 BACKGROUND

• Fernandez 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 BACKGROUND

• Garutti 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 BACKGROUND

• Batchelor 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 BACKGROUND

• Fraile 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.

  PMID: 36108953 BACKGROUND

• Rosero ID, Ramirez-Velez R, Lucia A, Martinez-Velilla N, Santos-Lozano A, Valenzuela PL, Morilla I, Izquierdo M. Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer. Cancers (Basel). 2019 Jul 5;11(7):944. doi: 10.3390/cancers11070944.

  PMID: 31284372 BACKGROUND

• Mainini C, Rebelo PF, Bardelli R, Kopliku B, Tenconi S, Costi S, Tedeschi C, Fugazzaro S. Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence? SAGE Open Med. 2016 Oct 19;4:2050312116673855. doi: 10.1177/2050312116673855. eCollection 2016.

  PMID: 27803808 BACKGROUND

• Mans CM, Reeve JC, Elkins MR. Postoperative outcomes following preoperative inspiratory muscle training in patients undergoing cardiothoracic or upper abdominal surgery: a systematic review and meta analysis. Clin Rehabil. 2015 May;29(5):426-38. doi: 10.1177/0269215514545350. Epub 2014 Aug 26.

  PMID: 25160007 BACKGROUND

• Kendall F, Oliveira J, Peleteiro B, Pinho P, Bastos PT. Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disabil Rehabil. 2018 Apr;40(8):864-882. doi: 10.1080/09638288.2016.1277396. Epub 2017 Jan 17.

  PMID: 28093920 BACKGROUND

• Cavalheri V, Burtin C, Formico VR, Nonoyama ML, Jenkins S, Spruit MA, Hill K. Exercise training undertaken by people within 12 months of lung resection for non-small cell lung cancer. Cochrane Database Syst Rev. 2019 Jun 17;6(6):CD009955. doi: 10.1002/14651858.CD009955.pub3.

  PMID: 31204439 BACKGROUND

• Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.

  PMID: 27226400 BACKGROUND

• Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD012020. doi: 10.1002/14651858.CD012020.pub2.

  PMID: 28589547 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Postoperative Complications

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos A Fraile Olivero, MD, PhD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Fraile Olivero, MD, PhD

CONTACT

+34917043708; carlosalfredo.fraile@salud.madrid.org

Lidia Sotillo, MD

CONTACT

+34917043717; lidia.sotillo@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 13, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)