An observational study in Fibrosis, Pulmonary, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Idiopathic pulmonary fibrosis (IPF) is a rare chronic progressive disease of unknown etiology that affects physical and emotional well-being. It is characterized by irreversible loss of lung function due to fibrosis, which manifests itself with cough, dyspnea, and impaired quality of life. Lung transplantation is limited to a minority of patients and patients receive anti-fibrotic therapy in addition to supportive/palliative treatments. In light of the broad definition of pulmonary rehabilitation, and by virtue of the multidisciplinary nature of the process, the present study aims to observe the effects of the rehabilitation counseling offered to patients who attend the IPF clinic at the Pneumology Operating Unit of the IRCCS Company Bologna University Hospital, as part of the Intercompany PDTA (diagnostic therapeutic care path) for Pulmonary Fibrosis: the Intercompany PDTA for patients suffering from idiopathic pulmonary fibrosis involves a multidisciplinary approach which, also through therapeutic education/counselling, aims among others to "Offer the patient the opportunity to participate in clinical studies to increase knowledge about the disease and/or have access to innovative treatments". Primary objectives
Evaluate the improvement in functional capacity and cardiorespiratory endurance.
Secondary objectives
The study plans to enroll 40 patients newly diagnosed with IPF
Inclusion criteria:
Exclusion criteria:
The sessions will be planned following the criteria of frequency, intensity, time and type of exercise:
Frequency: one meeting/every fifteen days in the first month and one meeting every fifteen days (+/- five days) in the second and third months.
Intensity: sixty minutes (with mBorg three dyspnea and minimum peripheral saturation 88%) Time: sixty minutes Type of treatment: exercises from the therapeutic education brochure.
Endpoints measures:
685 studies on the registry are indexed under Pulmonary Fibrosis; 120 are open to participants now.
This study's planned enrollment of 40 is below the median of 130 across 231 observational studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 509 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients newly diagnosed with IPF will be enlisted but only who comply with the criteria for rehabilitation care:
6MWT -meters ≥ 200 (Functionalcapacity); O2 therapy (Lt/min.) ≤ 3; Resting SpO2 ≥ 91% (Peripheraloxygensaturation); FVC (% predicted) ≥ 50% (Pulmonaryfunction); DLCO ≥ 30%(Pulmonaryfunction); mBorg at rest (score) ≤ 4 (Dyspnea); mMRC (score) ≤ 3 (Dyspnea)
As IPF is a rare disease, it is estimated that 20 patients/year can be enrolled on the basis of of the cases relating to previous years, therefore, considering the two years of enrolment, we expect to be able to enroll a total number of 40 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Effectiveness of the rehabilitation intervention contained in the PDTAI (Inter-company diagnostic and therapeutic pathway)
% of patients participating in the physiotherapy session program, at least that 80% of the total enlisted participate in the cycle of sessions proposed.
Time frame: 56 months
Improvement of functional capacity and cardiorespiratory endurance
Six Minute Walking Test (6MWT). This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis. MCID range from 21.7 to 45 meters. One reduction of more than 50 meters in 6 months increases mortality by three times
Time frame: 56 months
% Survival of patients with IPF.
% Survival of patients with IPF.
Time frame: 56 months
Caregiver Strain Index
Evaluate the emotional burden of the caregiver in assisting the affected person by IPF
Time frame: 56 months
EuroQoL scale (EQ-5D-5L)
Evaluate the improvement in quality of life
Time frame: 56 months
Barthel Index Dyspnea
Evaluate the modification of disability
Time frame: 56 months
Fatigue Assessment Scale (FAS)
Evaluate the patient's fatigue and its evolution during the course of the disease. Fatigue is associated with dyspnea, impacts daily life activities and quality of life.
Time frame: 56 months
Modified British Medical Research Council (mMRC)
Evaluate the trend and evolution of dyspnea at rest and in relation to completion of common daily activities
Time frame: 56 months
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Jul 2027, 55 months after the start.
Of 101 non-industry observational studies under Pulmonary Fibrosis, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 96. This study's planned 55 months is close to that.
Counting every sponsor, half of 119 studies reached it within 45 months; a quarter within 24 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
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