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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Interventions | Other | No intervention |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Dr Raja | Contact | 07955229245 | jessica.raja2@nhs.net | |
| Elisabetta Professor Renzoni | Contact | elisabetta.renzoni@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | Recruiting | London | SW36NP | United Kingdom |
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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| No intervention | Other | No intervention |
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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 |
| 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 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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