Surgical Procedure, UnspecifiedFPoCNCT06732193
Fissios© and Postoperative Complications (FPoC Trial)
A study testing On-site respiratory physiotherapy and Fissios App in people with Surgical Procedure, Unspecified and Non Small Cell Lung Cancer, run by Carlos Alfredo Fraile Olivero, MD, PhD. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Procedure, Unspecified, Non Small Cell Lung Cancer, Surgery Scheduled
- What is being tested?
- On-site respiratory physiotherapy and Fissios App
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Carlos Alfredo Fraile Olivero, PhD, +34917043708, carlosalfredo.fraile@salud.madrid.org
Carlos Alfredo Fraile Olivero, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Procedure, Unspecified, Non Small Cell Lung Cancer, Surgery Scheduled, Thoracic Surgery, Postoperative Complications, Perioperative Care
- Being tested
- On-site respiratory physiotherapy, Fissios App
- Keywords
- Respiratory physiotherapy, Smartphone App, Post-operative complications, Peri-operative physical training
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-site respiratory physiotherapyProcedure or surgery
The patient attends face-to-face physiotherapy sessions prescribed by the doctor.
Fissios AppDevice
The patient uses the Fissios App to perform respiratory physiotherapy exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: On-site respiratory physiotherapy; Device: Fissios App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Development of at least one adverse clinical event categorised as a postoperative complication during hospital admission. Immediately after the surgery until discharge.
Measured: Through postoperative evolution, an average of 2 weeks.
Secondary outcomes (5)
Duration of pleural drainage
Time that the patient has pleural drainage from the end of surgery until medical discharge.
Measured: Through postoperative evolution, an average of 2 weeks.
Mortality
Patient status at the moment of discharge.
Measured: During hospitalization period, an average of 2 weeks.
Hospital readmission
Any clinical situation requiring hospital admission
Measured: Within 30 days of discharge from hospital
Mortality
Measured: During the first 30 days after surgery
Mortality
Measured: During the first 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start20 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos Alfredo Fraile Olivero, MD, PhD.
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery, Asociación Española de Afectados de Cáncer de Pulmón (AEACaP), Medtronic General Research Grant, Spanish Society of Thoracic Surgery (SECT)
- Responsible party
- Sponsor-investigator, Carlos Alfredo Fraile Olivero, MD, PhD., Hospital San Carlos, Madrid
- Investigators
- Carlos A Fraile Olivero, MD, PhD, Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732193
- Sponsor's protocol ID
- 22/310-EC_X
- Acronym
- FPoC
- Status last verified
- Sep 2025
- First submitted
- 25 Nov 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15949587Fernandez 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.
PubMed 25555970Garutti 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.
PubMed 35585017Batchelor 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.
PubMed 30304509Fraile 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.
PubMed 36108953Rosero 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.
PubMed 31284372Mainini 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.
PubMed 27803808Mans 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.
PubMed 25160007Kendall 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.
PubMed 28093920Cavalheri 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.
PubMed 31204439Sebio 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.
PubMed 27226400Cavalheri 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.
PubMed 28589547Fraile Olivero CA, Sotillo Valenzuela L, Albarran Vidal V, Barcelo Cal JG, Alen Villamayor V, Hernando Trancho F, Fernandez Martin E, Calatayud Gastardi J, Gomez Martinez AM, Arribas Manzanal PD, Santos P, Fernandez Blanco R, Cal Vazquez MI, Milla Collado L, Rodriguez M, Perna V, Romero Roman A, Ordonez CA, Jarabo Sarceda JR. Fissios and postoperative complications (FPoC trial): a multicentre, randomised, controlled clinical trial. BMJ Open Respir Res. 2026 Jun 15;13(1):e003269. doi: 10.1136/bmjresp-2025-003269.
PubMed 42303312
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06732193
- Acronym / sponsor ID
- FPoC / 22/310-EC_X
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Carlos Alfredo Fraile Olivero, MD, PhD.University, hospital or other
- Collaborators
- Spanish Society of Pneumology and Thoracic Surgery, Asociación Española de Afectados de Cáncer de Pulmón (AEACaP), Medtronic General Research Grant, Spanish Society of Thoracic Surgery (SECT)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person respiratory physiotherapy | Active comparator | Procedure: On-site respiratory physiotherapyThe patient must attend the respiratory physiotherapy sessions given by physiotherapists at the place and time established in each centre, before and after surgery. |
| Face-to-face respiratory physiotherapy plus use of the Fissios App | Experimental | Procedure: On-site respiratory physiotherapy, Device: Fissios AppThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-site respiratory physiotherapyThe patient attends face-to-face physiotherapy sessions prescribed by the doctor. | Procedure or surgery | Face-to-face respiratory physiotherapy plus use of the Fissios App, In-person respiratory physiotherapy |
| Fissios AppThe patient uses the Fissios App to perform respiratory physiotherapy exercises. | Device | Face-to-face respiratory physiotherapy plus use of the Fissios App |
Primary outcome
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.
5 secondary outcomes
Duration of pleural drainage
Time frame: Through postoperative evolution, an average of 2 weeks.
Mortality
Time frame: During hospitalization period, an average of 2 weeks.
Hospital readmission
Time frame: Within 30 days of discharge from hospital
Mortality
Time frame: During the first 30 days after surgery
Mortality
Time frame: During the first 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 15949587Rami-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.
- Results publication: PubMed 25555970Fernandez 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.
- Results publication: PubMed 35585017Garutti 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.
- Results publication: PubMed 30304509Batchelor 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.
- Results publication: PubMed 36108953Fraile 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.
- Results publication: PubMed 31284372Rosero 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.
- Results publication: PubMed 27803808Mainini 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.
- Results publication: PubMed 25160007Mans 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.
- Results publication: PubMed 28093920Kendall 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.
- Results publication: PubMed 31204439Cavalheri 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.
- Results publication: PubMed 27226400Sebio 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.
- Results publication: PubMed 28589547Cavalheri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos A Fraile Olivero, MD, PhD principal investigator
Hospital San Carlos, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-site respiratory physiotherapy and Fissios App in people with Surgical Procedure, Unspecified and Non Small Cell Lung Cancer, run by Carlos Alfredo Fraile Olivero, MD, PhD. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos A Fraile Olivero, MD, PhD (+34917043708, carlosalfredo.fraile@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: Through postoperative evolution, an average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06732193, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.