NCT Number: NCT07332117
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
Interested in participating?
Request Info18 year and older
All sexes
Observational
London, SW36NP, United Kingdom
Location status: Recruiting
Elisabetta Professor Renzoni
CONTACT
Elisabetta Professor Renzoni
PRINCIPAL_INVESTIGATOR
Jessica Dr Raja
CONTACT
Jessica Dr Raja
PRINCIPAL_INVESTIGATOR
Rasleen Kahai
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
No intervention
Time frame: For study recruitment window of 6 months
Measured by number of patients consenting/number of patients contacted and rationale for declining
Time frame: For the 6 month recruitment window
Number of patients attending both visits (baseline and 4 months) and rationale for dropout
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)
Time frame: To be performed at baseline visit and 4 month visit
Likert scale on use of BIA and muscle ultrasound
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)
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)
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)
Time frame: To be performed at baseline visit and at 4 month visit
Time frame: To be performed at baseline visit and at 4 month visit
Time frame: To be performed at baseline visit and at 4 month visit
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)
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)
Time frame: Performed at baseline visit and 4 month visit
Body weight - measured with low clothes and without shoes in kilograms (kg)
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.
Contact information is provided by the study sponsor or research team.
Elisabetta Professor Renzoni
CONTACT
Jessica Dr Raja
CONTACT
Royal Brompton & Harefield NHS Foundation Trust
Other
Acronym: AF-BMC
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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