Fibrosis, PulmonaryNCT06815185
Rehabilitation Counselling for Patients with Interstitial Lung Disease
An observational study of Fibrosis, Pulmonary, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosis, Pulmonary
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2022to 15 Jul 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- age\>/= 18 years old;
- Obtaining the patient\'s informed consent
Who cannot join
- Diagnosis of active cancer
- Situations of clinical instability, clinical aggravation such as to consider unsuitable the individual to treatment because he or she is no longer able to go to follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Enrica Cavalli Cavalli, MD, 00390512142286, enrica.cavalli@aosp.bo.it
About this study
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 effectiveness of the rehabilitation intervention contained in the PDTAI (Intercompany diagnostic therapeutic care path )
- Evaluate the improvement in functional capacity and cardiorespiratory endurance. Secondary objectives
- Evaluate the progress and evolution of the pathology.
- Evaluate the emotional burden of the caregiver in caring for the individual suffering from IPF
- Evaluate the improvement in quality of life.
- Evaluate the change in disability.
- Evaluate the patient\'s fatigue and its evolution over the course of the disease. Fatigue is associated with dyspnea, impacts daily living activities and quality of life.
- Evaluate the progress and evolution of dyspnea at rest and in relation to the performance of common daily activities.
Read more
The study plans to enroll 40 patients newly diagnosed with IPF
Inclusion criteria:
- adulthood ≥18 years
- Obtaining the patient\'s informed consent
Exclusion criteria:
- diagnosis of cancer in the active phase
- Situations of clinical instability, of clinical worsening such as to deem the individual unsuitable for treatment because they are no longer able to go to follow up visits The included patients will receive the therapeutic education brochure from the physiotherapist and will be trained to perform the exercises during hospital visits. The physiotherapist will be able to evaluate and modify the retraining program based on the user\'s response according to the principles based on the individualized rehabilitation project. The direct comparison with the user allows to obtain a functional improvement adapted to the needs and performance of the person but at the same time, according to the principles of empowerment, helps the subject to become aware of their functional limits and address them with a more personalized.
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:
- % of patients participating in the physiotherapy session programme. It is expected that at least 80% of the total enrolled participants will participate in the proposed session cycle.
- Six Minute Walking Test. This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis.
- % Survival of IPF patients.
- Caregiver Strain Index.
- EuroQoL scale.
- Barthel Index Dyspnea.
- Fatigue Assessment Scale.
- Modified British Medical Research Council.
- Conditions
- Fibrosis, Pulmonary
- Keywords
- rehabilitation counselling
- Medical subject headings
- Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 56 months
Secondary outcomes (6)
% Survival of patients with IPF.
% Survival of patients with IPF.
Measured: 56 months
Caregiver Strain Index
Evaluate the emotional burden of the caregiver in assisting the affected person by IPF
Measured: 56 months
EuroQoL scale (EQ-5D-5L)
Evaluate the improvement in quality of life
Measured: 56 months
Barthel Index Dyspnea
Evaluate the modification of disability
Measured: 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.
Measured: 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
Measured: 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Dec 2022
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrica Cavalli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815185
- Sponsor's protocol ID
- ReF2202
- Status last verified
- Sep 2024
- First submitted
- 22 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Counselling for Patients with Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06815185
- Acronym / sponsor ID
- ReF2202
- Conditions
- Fibrosis, Pulmonary
- Keywords
- rehabilitation counselling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 7 Feb 2025 (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.
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 effectiveness of the rehabilitation intervention contained in the PDTAI (Intercompany diagnostic therapeutic care path )
- Evaluate the improvement in functional capacity and cardiorespiratory endurance. Secondary objectives
- Evaluate the progress and evolution of the pathology.
- Evaluate the emotional burden of the caregiver in caring for the individual suffering from IPF
- Evaluate the improvement in quality of life.
- Evaluate the change in disability.
- Evaluate the patient\'s fatigue and its evolution over the course of the disease. Fatigue is associated with dyspnea, impacts daily living activities and quality of life.
- Evaluate the progress and evolution of dyspnea at rest and in relation to the performance of common daily activities.
The study plans to enroll 40 patients newly diagnosed with IPF
Inclusion criteria:
- adulthood ≥18 years
- Obtaining the patient\'s informed consent
Exclusion criteria:
- diagnosis of cancer in the active phase
- Situations of clinical instability, of clinical worsening such as to deem the individual unsuitable for treatment because they are no longer able to go to follow up visits The included patients will receive the therapeutic education brochure from the physiotherapist and will be trained to perform the exercises during hospital visits. The physiotherapist will be able to evaluate and modify the retraining program based on the user\'s response according to the principles based on the individualized rehabilitation project. The direct comparison with the user allows to obtain a functional improvement adapted to the needs and performance of the person but at the same time, according to the principles of empowerment, helps the subject to become aware of their functional limits and address them with a more personalized.
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:
- % of patients participating in the physiotherapy session programme. It is expected that at least 80% of the total enrolled participants will participate in the proposed session cycle.
- Six Minute Walking Test. This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis.
- % Survival of IPF patients.
- Caregiver Strain Index.
- EuroQoL scale.
- Barthel Index Dyspnea.
- Fatigue Assessment Scale.
- Modified British Medical Research Council.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- age\>/= 18 years old;
- Obtaining the patient\'s informed consent
Key exclusion criteria (2 listed)
- Diagnosis of active cancer
- Situations of clinical instability, clinical aggravation such as to consider unsuitable the individual to treatment because he or she is no longer able to go to follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of the rehabilitation intervention contained in the PDTAI (Inter-company diagnostic and therapeutic pathway)
Time frame: 56 months
% of patients participating in the physiotherapy session program, at least that 80% of the total enlisted participate in the cycle of sessions proposed.
Improvement of functional capacity and cardiorespiratory endurance
Time frame: 56 months
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
6 secondary outcomes
% Survival of patients with IPF.
Time frame: 56 months
Caregiver Strain Index
Time frame: 56 months
EuroQoL scale (EQ-5D-5L)
Time frame: 56 months
Barthel Index Dyspnea
Time frame: 56 months
Fatigue Assessment Scale (FAS)
Time frame: 56 months
Modified British Medical Research Council (mMRC)
Time frame: 56 months
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 7 Feb 2025.
- 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.
Enrica Cavalli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosis, Pulmonary, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 2 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 7 Feb 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 Italy. 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 Enrica Cavalli, MD (0512142285, enrica.cavalli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the rehabilitation intervention contained in the PDTAI (Inter-company diagnostic and therapeutic pathway) (time frame: 56 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.