Actively Recruiting
Fissios© and Postoperative Complications (FPoC Trial)
Led by Carlos Alfredo Fraile Olivero, MD, PhD. · Updated on 2025-09-11
560
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
Sponsors
C
Carlos Alfredo Fraile Olivero, MD, PhD.
Lead Sponsor
S
Spanish Society of Pneumology and Thoracic Surgery (SEPAR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fissios© and Postoperative Complications (FPoC Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age.
- Scheduled for lung resection surgery due to diagnosis or suspicion of non-small cell lung carcinoma.
- Undergoing anatomical lung resection surgery such as segmental resection, lobectomy, or pneumonectomy by conventional or minimally invasive methods.
- Possess a compatible smart mobile device and have the ability or support to use the Fissios App.
- Willing and committed to participate in the study.
- Able to provide informed consent to participate.
You will not qualify if you...
- Medical contraindication to performing respiratory physiotherapy exercises.
- Do not have a smart mobile device compatible with the Fissios App.
- Unable to perform respiratory exercises due to physical or psychological reasons.
- Unable to complete informed consent for participation.
- Refuse to participate in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
C
Carlos A Fraile Olivero, MD, PhD
CONTACT
L
Lidia Sotillo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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