Measuring body fat and thigh muscle in people with pulmonary fibrosis starting anti-fibrotic drugs
A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
This project will test whether quick bioelectrical impedance measurements and thigh muscle ultrasound can detect changes in body fat and muscle in adults with IPF or progressive pulmonary fibrosis who are starting anti-fibrotic medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07332117 on ClinicalTrials.gov |
What this trial studies
This observational pilot follows adults with idiopathic or progressive pulmonary fibrosis who are newly starting nintedanib or pirfenidone, measuring body composition before treatment and again four months after starting therapy. Body composition will be measured using bioimpedance analysis (BIA) and quadriceps muscle ultrasound, alongside mid-arm circumference and functional tests such as sit-to-stand, walking speed, and muscle strength. Participants will also complete questionnaires on quality of life, physical activity and gastrointestinal symptoms and provide a 3-day diet diary to contextualize any changes. The study focuses on feasibility and whether these noninvasive measures detect changes that weight or BMI would miss.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of idiopathic pulmonary fibrosis or progressive pulmonary fibrosis who are about to start nintedanib or pirfenidone, can give informed consent, and do not have exclusions like pacemakers, active enteral feeding, recent major weight loss, or high-dose steroids.
Not a fit: People already on anti-fibrotic drugs, those with implantable cardiac devices, current enteral feeding, significant recent weight loss, severe musculoskeletal problems, heart failure, pregnancy, or limited life expectancy are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, this approach could allow earlier and more accurate detection of muscle or fat loss related to anti-fibrotic side effects so clinicians can offer nutritional or physical interventions sooner.
How similar studies have performed: BIA and muscle ultrasound are established, useful tools in other lung conditions, but applying them specifically to detect body composition changes from anti-fibrotic drugs is a novel, largely untested application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of Idiopathic pulmonary fibrosis or progressive pulmonary fibrosis * Newly commencing anti-fibrotic medication (either nintedanib or pirfenidone) * Subject aged \> 18 years * Able to willingly give consent Exclusion Criteria: * Co-morbidities currently requiring enteral feeding * 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
Where this trial is running
London
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jessica Dr Raja
- Email: jessica.raja2@nhs.net
- Phone: 07955229245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.