Rehabilitation in Patients With Pulmonary Fibrosis

NCT06677047 | Not Yet Recruiting

• 1 other identifier: ILD& Rehabilitation
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the effects of exercise rehabilitation on the functional status of patients with pulmonary fibrosis, assessing both physical and psychological dimensions of health. By identifying significant improvements, we can contribute to the development of comprehensive rehabilitation strategies that enhance patient outcomes and foster a better quality of life for those affected by this challenging condition

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• **Asses Health-Related Quality of Life:**

  Assessed through validated questionnaires such as the St. George's Respiratory Questionnaire (SGRQ)

  Baseline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

\*\*Demographic Data Collection:\*\* * Age, sex, duration of pulmonary fibrosis, and medical history. 2\. \*\*Pulmonary Function Testing:\*\* * Spirometry will be conducted to assess Forced Vital Capacity (FVC) and Forced Expiratory Volume in one second (FEV1). 3\. \*\*Functional Capacity Assessment:\*\* * The Six-Minute Walk Test (6MWT) will be performed to evaluate baseline exercise tolerance. 4\. \*\*Quality of Life Evaluation:\*\* * Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ) or Chronic Respiratory Disease Questionnaire (CRQ). 5\. \*\*Dyspnea Assessment:\*\* * Dyspnea levels will be measured using the Modified Medical Research Council (mMRC) dyspnea scale. * Exercise Rehabilitation Program Participants will engage in a structured 8-week exercise rehabilitation program, which includes: * \*\*Supervised Exercise Sessions:\*\* * Participants will attend twice-weekly sessions led by trained physiotherapists, focusing on aerobic

You may qualify if:

• \. \*\*Diagnosis of Pulmonary Fibrosis:\*\*
• Patients must have a confirmed diagnosis of pulmonary fibrosis, as determined by clinical evaluation and imaging studies (e.g., high-resolution computed tomography).
• \. \*\*Age Range:\*\*
• Participants should be adults aged 18 years and older to capture the adult population affected by the disease.
• \. \*\*Stable Clinical Condition:\*\*
• Patients must be in a stable clinical condition, defined as no exacerbations or significant changes in treatment for at least four weeks prior to enrollmen

You may not qualify if:

• \. \*\*Other Significant Lung Diseases:\*\*
• Patients with concurrent respiratory conditions (e.g., chronic obstructive pulmonary disease, asthma, or lung cancer) that could confound the results.
• \. \*\*Acute Exacerbations:\*\*
• Individuals experiencing an acute exacerbation of pulmonary fibrosis or any significant respiratory illness within four weeks prior to enrollment.
• \. \*\*Severe Comorbidities:\*\*
• Patients with severe cardiovascular disease, uncontrolled hypertension, major neurological disorders, or musculoskeletal problems that would impede participation in exercise.
• \. \*\*Cognitive Impairment:\*\*
• Individuals with cognitive impairments that prevent them from understanding the study procedures or following the rehabilitation program.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.

  PMID: 37286219 RESULT

Central Study Contacts

Hend Mohamed Sayed, Doctor

CONTACT

01098988712; hend.m.saleh@gmail.com

Ahmed mohamed Shadad, Doctor

CONTACT

0111117930; Shaddad_ahmad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 6, 2024
• Study Start: January 20, 2025
• Primary Completion: June 20, 2025
• Study Completion: August 20, 2025
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share