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RecruitingNCT06815185Updated Feb 7, 2025

Rehabilitation Counselling for Patients with Interstitial Lung Disease

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

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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

  1. Evaluate the effectiveness of the rehabilitation intervention contained in the PDTAI (Intercompany diagnostic therapeutic care path )
  2. Evaluate the improvement in functional capacity and cardiorespiratory endurance.

    Secondary objectives

  3. Evaluate the progress and evolution of the pathology.
  4. Evaluate the emotional burden of the caregiver in caring for the individual suffering from IPF
  5. Evaluate the improvement in quality of life.
  6. Evaluate the change in disability.
  7. 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.
  8. 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:

  1. % 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.
  2. Six Minute Walking Test. This test is validated for multiple pathologies, including idiopathic pulmonary fibrosis.
  3. % Survival of IPF patients.
  4. Caregiver Strain Index.
  5. EuroQoL scale.
  6. Barthel Index Dyspnea.
  7. Fatigue Assessment Scale.
  8. Modified British Medical Research Council.
02

Conditions studied

  • Fibrosis, Pulmonary

Browse trials for

Keywords

  • rehabilitation counselling
03

In context

Pulmonary Fibrosis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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.

Inclusion criteria

  • age>/= 18 years old;
  • Obtaining the patient\'s informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. % Survival of patients with IPF.

    % Survival of patients with IPF.

    Time frame: 56 months

  2. Caregiver Strain Index

    Evaluate the emotional burden of the caregiver in assisting the affected person by IPF

    Time frame: 56 months

  3. EuroQoL scale (EQ-5D-5L)

    Evaluate the improvement in quality of life

    Time frame: 56 months

  4. Barthel Index Dyspnea

    Evaluate the modification of disability

    Time frame: 56 months

  5. 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

  6. 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

07

Study locations

1 of 1 sites recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Bologna, Bologna 40138, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Jan 22, 2025
First posted
Feb 7, 2025
StartActual
Dec 15, 2022
Primary completionEst.
Jul 15, 2027
CompletionEst.
Jul 15, 2027
Last update
Feb 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06815185
Responsible party
Sponsor
First posted
Feb 7, 2025
Start date
Dec 15, 2022
Primary completion
Jul 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Feb 7, 2025

Study contacts

Enrica Cavalli, MD
Contact
enrica.cavalli@aosp.bo.it
0512142285
Enrica Cavalli, MD
principal investigator · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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