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NCT Number: NCT07332117

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

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Progressive Pulmonary Fibrosis Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton Hospital

London, SW36NP, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions

Other

No intervention

No intervention

Other

No intervention

Primary outcomes

  1. Recruitment of patients to study

    Time frame: For study recruitment window of 6 months

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

  2. Implementation of study protocol

    Time frame: For the 6 month recruitment window

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

  3. Feasibility of collection of data

    Time frame: For the the study recruitment window of 6 months

    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)

  4. Acceptability of use of BIA and muscle ultrasound

    Time frame: To be performed at baseline visit and 4 month visit

    Likert scale on use of BIA and muscle ultrasound

Secondary outcomes

  1. Bioelectrical impedance analysis (BIA)

    Time frame: Performed at baseline visit and at 4 month visit

    Messurements taken with BIA include fat-free mass index (FFMI) kg/m2, phase angle (PhA) and skeletal muscle mass (SMM)

  2. Five times sit to stand (5TST)

    Time frame: To be performed at baseline visit and at 4 month visit

    Time taken from moving from sitting to standing position for 5 repetitions will be recorded (seconds)

  3. Four metre gait speed (4MGS)

    Time frame: To be performed at baseline visit and 4 month visit

    Time taken to complete a 4 metre distance walking will be recorded and repeated 3 times (seconds)

  4. Questionnaires assessing gastrointestinal symptoms

    Time frame: To be performed at baseline visit and at 4 month visit

    • 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

  5. Questionnaires assessing respiratory symptoms and quality of life

    Time frame: To be performed at baseline visit and at 4 month visit

    • The King's brief interstitial lung disease questionnaire (K-BILD) - a widely validated ILD-specific quality of life questionnaire

  6. Questionnaire to assess levels of physical activity

    Time frame: To be performed at baseline visit and at 4 month visit

    • International physical activity questionnaire (IPAQ)

  7. Muscle strength

    Time frame: Performed at baseline visit and 4 month visit

    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)

  8. Height

    Time frame: To be performed at baseline

    Height - will be taken from the most recent lung function test (within the previous 12 months) in metres (m)

  9. Body weight

    Time frame: Performed at baseline visit and 4 month visit

    Body weight - measured with low clothes and without shoes in kilograms (kg)

  10. Quadriceps ultrasound

    Time frame: To be performed at baseline visit and 4 month visit

    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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Acronym: AF-BMC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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