Rehabilitation Counselling for Patients with Interstitial Lung Disease

NCT06815185 | Recruiting

• 1 other identifier: ReF2202
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

• 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  56 months

Secondary Outcomes (6)

• % Survival of patients with IPF.

  56 months

• Caregiver Strain Index

  56 months

• EuroQoL scale (EQ-5D-5L)

  56 months

• Barthel Index Dyspnea

  56 months

• Fatigue Assessment Scale (FAS)

  56 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrica Cavalli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrica Cavalli, MD

CONTACT

0512142285; enrica.cavalli@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 7, 2025
• Study Start: December 15, 2022
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: February 7, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)