A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications

NCT07332117 | Recruiting

• 1 other identifier: IRAS ID: 358410
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound

Conditions

Progressive Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF)

Keywords

bioimpedance analysis; muscle ultrasound; body composition

Outcome Measures

Primary Outcomes (4)

• Recruitment of patients to study

  Measured by number of patients consenting/number of patients contacted and rationale for declining

  For study recruitment window of 6 months

• Implementation of study protocol

  Number of patients attending both visits (baseline and 4 months) and rationale for dropout

  For the 6 month recruitment window

• Feasibility of collection of data

  Collection of data from BIA (skeletal muscle index (SMI), phase angle (PhA) and fat free mass index (FFMI)) and muscle ultrasound (Anterior-posterior diameter of rectus femoris and cross sectional area of rectus femoris)

  For the the study recruitment window of 6 months

• Acceptability of use of BIA and muscle ultrasound

  Likert scale on use of BIA and muscle ultrasound

  To be performed at baseline visit and 4 month visit

Secondary Outcomes (10)

• Bioelectrical impedance analysis (BIA)

  Performed at baseline visit and at 4 month visit

• Five times sit to stand (5TST)

  To be performed at baseline visit and at 4 month visit

• Four metre gait speed (4MGS)

  To be performed at baseline visit and 4 month visit

• Questionnaires assessing gastrointestinal symptoms

  To be performed at baseline visit and at 4 month visit

• Questionnaires assessing respiratory symptoms and quality of life

  To be performed at baseline visit and at 4 month visit

Study Arms (2)

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.

Other: No Interventions; Other: 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.

Other: No Interventions; Other: No intervention

Interventions

No Interventions OTHER

No intervention

Control group; Patients to be commenced on anti-fibrotics

No intervention OTHER

No intervention

Control group; Patients to be commenced on anti-fibrotics

Eligibility Criteria

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

Study Population

Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton Hospital

London, SW36NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jessica Dr Raja

CONTACT

07955229245; jessica.raja2@nhs.net

Elisabetta Professor Renzoni

CONTACT

elisabetta.renzoni@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: January 12, 2026
• Study Start: September 9, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)