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.
Study Type
OBSERVATIONAL
Enrollment
30
No intervention
No intervention
Royal Brompton Hospital
London, United Kingdom
RECRUITINGRecruitment 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)
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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