Actively Recruiting
A Pilot Study to Assess Body Mass Composition Using Bioimpedance Analysis and Muscle Ultrasound in Patients with Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis on Anti-fibrotic Medications
Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2026-01-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how anti-fibrotic medications affect body mass composition in patients with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). These medications, such as nintedanib and pirfenidone, often cause side effects like nausea and loss of appetite, which may change body fat and muscle amounts. Traditional methods like weight and BMI don't detect these changes well, so this study uses bioimpedance analysis (BIA) and muscle ultrasound to better measure body composition. The study involves patients newly starting anti-fibrotic drugs and a control group of patients with similar lung disease but not beginning these medications. BIA measures body composition quickly by attaching electrodes for about 6 seconds, while muscle ultrasound assesses thigh muscle size. Additional measurements include mid-arm circumference, physical tests like sit-to-stand and walking speed, and questionnaires on quality of life, physical activity, and gastrointestinal symptoms. Participants will provide a 3-day diet diary as well. Assessments occur before starting the medications and again after four months to track changes. Researchers will evaluate the feasibility of these measurements, the acceptability of BIA and ultrasound, and collect data on muscle strength, body weight, height, and questionnaires at both time points. The study aims to understand the impact of anti-fibrotic drugs on body composition and related physical functions in these patients over this period.
CONDITIONS
Brief Title
A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic pulmonary fibrosis or progressive pulmonary fibrosis
- Newly starting anti-fibrotic medication (nintedanib or pirfenidone)
- Age over 18 years
- Able and willing to provide consent
You will not qualify if you...
- Currently require enteral feeding
- Weight loss greater than 10% in the past 3 to 6 months
- Significant musculoskeletal issues affecting muscle mass
- Receiving end of life care with less than 6 weeks expected survival
- Previous use of anti-fibrotic medications
- Currently taking more than 10mg daily of prednisolone
- Presence of implantable cardioverter defibrillator or permanent pacemaker
- Heart failure
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline measurements including bioelectrical impedance analysis (BIA), quadriceps muscle ultrasound, physical tests, questionnaires, and diet diary before starting anti-fibrotic medications.
1 baseline visit (in-person)
Duration - 4 months
Participants are observed for changes in body mass composition and physical function while on anti-fibrotic medications over 4 months.
1 follow-up visit (in-person) at 4 months
Trial Site Locations
Total: 1 location
1
Royal Brompton Hospital
London, United Kingdom, SW36NP
Actively Recruiting
Research Team
J
Jessica Dr Raja
E
Elisabetta Professor Renzoni
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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