A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
NCT ID: NCT07332117
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2025-09-09
2026-04-30
Brief Summary
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Detailed Description
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In addition to the use and tolerability of BIA and muscle ultrasound in this group of patients we will be also taking other measurements including mid-arm circumference and physical tests (sitting to standing, walking speed and muscle strength). We will also use questionnaires to ask about symptoms relating to quality of life, physical activity and gastrointestinal symptoms. Patients will also provide a 3-day diet diary. We will be performing all of the above tests at the beginning before patients start the anti-fibrotic drugs and then again 4 months after starting the drugs and assessing for any changes over this period of time.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Patients to be commenced on anti-fibrotics
Patients with either idiopathic pulmonary fibrosis or progressive pulmonary fibrosis planned to commenced anti-fibrotic medication (either pirfenidone or nintedanib) will be recruited.
No Interventions
No intervention
No intervention
No intervention
Control group
We will also recruit 20 controls with predominantly fibrotic lung disease. Only those with extent of disease \> 20% on HRCT as determined by PI and CI will be included. These are patients who in the opinion of the treating physician may require anti-fibrotic treatment in the future, but are not planned to start anti-fibrotic medications over the subsequent 4 months and have not previously been on anti-fibrotic medications.
No Interventions
No intervention
No intervention
No intervention
Interventions
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No Interventions
No intervention
No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone)
* Subject aged \> 18 years
* Able to willingly give consent
Exclusion Criteria
* Weight loss \> 10% in preceding 3-6 months
* Significant musculoskeletal issues that may impact muscle mass
* End of life care (expected \< 6 weeks left to live)
* Previous anti-fibrotic use
* Currently on \> Prednisolone 10mg daily
* Presence of implantable cardioverter defibrillator (ICD) or permanent pacemaker (PPM)
* Heart failure
* Pregnancy
18 Years
ALL
No
Sponsors
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Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Royal Brompton Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS ID: 358410
Identifier Type: -
Identifier Source: org_study_id
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