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

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

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF); Progressive Pulmonary Fibrosis
• Intervention / Treatment: Other: No intervention; Other: No Interventions

Detailed Description

This study will be looking at the measurement of body mass composition using bioimpedance analysis (BIA) and quadriceps muscle ultrasound in patients with fibrotic lung disease who are on anti-fibrotic drugs. These anti-fibrotic drugs (nintedanib and pirfenidone) commonly cause gastrointestinal side effects such nausea, loss of appetite and diarrhoea. As a result of these side effects some patients may have a change in the amount of body fat and muscle. This change is not able to be identified using weight or body mass index (BMI). BIA machines are a quick and easy method of looking at body mass composition and require patients to have electrodes attached to their body for approximately 6 seconds. BIA machines are already in routine care for patients with other types of lung conditions. Using muscle ultrasound we will be able to measure the size of the muscle in the thigh.

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Jessica Dr Raja; Phone Number: 07955229245; Email: jessica.raja2@nhs.net
• Study Contact Backup: Name: Elisabetta Professor Renzoni; Email: elisabetta.renzoni@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SW36NP
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Jessica Dr Raja; Phone Number: 07955229245; Email: jessica.raja2@nhs.net
    • Contact: Elisabetta Professor Renzoni; Email: elisabetta.renzoni@nhs.net
    • Principal Investigator: Jessica Dr Raja
    • Principal Investigator: Rasleen Kahai
    • Principal Investigator: Elisabetta Professor Renzoni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 intervention; No intervention; Other: No Interventions; 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 intervention; No intervention; Other: No Interventions; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioelectrical impedance analysis (BIA)	Messurements taken with BIA include fat-free mass index (FFMI) kg/m2, phase angle (PhA) and skeletal muscle mass (SMM)	Performed at baseline visit and at 4 month visit
Five times sit to stand (5TST)	Time taken from moving from sitting to standing position for 5 repetitions will be recorded (seconds)	To be performed at baseline visit and at 4 month visit
Four metre gait speed (4MGS)	Time taken to complete a 4 metre distance walking will be recorded and repeated 3 times (seconds)	To be performed at baseline visit and 4 month visit
Questionnaires assessing gastrointestinal symptoms	Gastrointestinal symptom rating scale (GSRS) to quantify the severity and impact of gastrointestinal symptoms; Visual analogue scale (VAS) for loss of appetite, nausea and diarrhoea; Past 1 week, how many bowel movements per day	To be performed at baseline visit and at 4 month visit
Questionnaires assessing respiratory symptoms and quality of life	1) The King's brief interstitial lung disease questionnaire (K-BILD) - a widely validated ILD-specific quality of life questionnaire	To be performed at baseline visit and at 4 month visit
Questionnaire to assess levels of physical activity	1) International physical activity questionnaire (IPAQ)	To be performed at baseline visit and at 4 month visit
Muscle strength	Isometric quadriceps testing - patient seated on a treatment table with hips flexed approximately 85 degrees, thigh is secured to treatment table with one velcro strap placed across thighs, strap attached to patient's ankle and instructed to push their leg forward. This is repeated 3 times with the best reading recorded in kilograms (kg)	Performed at baseline visit and 4 month visit
Height	Height - will be taken from the most recent lung function test (within the previous 12 months) in metres (m)	To be performed at baseline
Body weight	Body weight - measured with low clothes and without shoes in kilograms (kg)	Performed at baseline visit and 4 month visit
Quadriceps ultrasound	Using phillips (Lumify) linear transducer (C12-4) measurements will be taken by placing the probe perpendicular to the long axis of the the thigh three-fifths of thr distance from the anterior superior iliac spine to the superior patellar border. The average of 3 measurements will be taken of both the anterior-posterior (AP) (cm) and the cross-sectional area of rectus femoris (RFcsa) (cm2). Due to limitations with available software, images will be sent to ImageJ software to determine RFcsa.	To be performed at baseline visit and 4 month visit

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: body composition; bioimpedance analysis; muscle ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: IRAS ID: 358410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Identifiable individual participant data will not be shared with other researchers, however de-identified study results will be submitted to journals for publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No