Rehabilitation Counselling for Patients with Interstitial Lung Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06815185
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Enrica Cavalli, MD
Principal Investigator Affiliation IRCCS Azienda Ospedaliero-Universitaria di Bologna
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibrosis, Pulmonary

Contact a Trial Team

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International Sites

Bologna, Italy

Status

Recruiting

Address

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , 40138

Site Contact

Enrica Cavalli Cavalli, MD

[email protected]

00390512142286

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