Actively Recruiting

Age: 18Years +
All Genders
ID07332117

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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