An observational study in Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
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.
551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 30 is below the median of 158 across 154 observational studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)
Exclusion Criteria:
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
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
No intervention
No intervention
Recruitment of patients to study
Measured by number of patients consenting/number of patients contacted and rationale for declining
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: To be performed at baseline visit and 4 month visit
Bioelectrical impedance analysis (BIA)
Messurements taken with BIA include fat-free mass index (FFMI) kg/m2, phase angle (PhA) and skeletal muscle mass (SMM)
Time frame: 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)
Time frame: 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)
Time frame: To be performed at baseline visit and 4 month visit
Questionnaires assessing gastrointestinal symptoms
1. Gastrointestinal symptom rating scale (GSRS) to quantify the severity and impact of gastrointestinal symptoms 2. Visual analogue scale (VAS) for loss of appetite, nausea and diarrhoea 3. Past 1 week, how many bowel movements per day
Time frame: 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
Time frame: To be performed at baseline visit and at 4 month visit
Questionnaire to assess levels of physical activity
1\) International physical activity questionnaire (IPAQ)
Time frame: 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)
Time frame: 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)
Time frame: To be performed at baseline
Body weight
Body weight - measured with low clothes and without shoes in kilograms (kg)
Time frame: 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.
Time frame: To be performed at baseline visit and 4 month visit
Plan to share: No — Identifiable individual participant data will not be shared with other researchers, however de-identified study results will be submitted to journals for publication.
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Royal Brompton & Harefield NHS Foundation Trust