Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
Conditions
Keywords
bioimpedance analysis, muscle ultrasound, body composition
Brief summary
To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound
Detailed description
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.
Interventions
OTHERNo Interventions
No intervention
OTHERNo intervention
No intervention
Sponsors
Royal Brompton & Harefield NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment of patients to study | For study recruitment window of 6 months | Measured by number of patients consenting/number of patients contacted and rationale for declining |
| Implementation of study protocol | For the 6 month recruitment window | Number of patients attending both visits (baseline and 4 months) and rationale for dropout |
| Feasibility of collection of data | 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) |
| Acceptability of use of BIA and muscle ultrasound | To be performed at baseline visit and 4 month visit | Likert scale on use of BIA and muscle ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaires assessing respiratory symptoms and quality of life | To be performed at baseline visit and at 4 month visit | 1\) The King's brief interstitial lung disease questionnaire (K-BILD) - a widely validated ILD-specific quality of life questionnaire |
| Questionnaire to assess levels of physical activity | To be performed at baseline visit and at 4 month visit | 1\) International physical activity questionnaire (IPAQ) |
| Muscle strength | 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) |
| Bioelectrical impedance analysis (BIA) | 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) |
| Body weight | Performed at baseline visit and 4 month visit | Body weight - measured with low clothes and without shoes in kilograms (kg) |
| Quadriceps ultrasound | 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. |
| Height | To be performed at baseline | Height - will be taken from the most recent lung function test (within the previous 12 months) in metres (m) |
| Five times sit to stand (5TST) | 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) |
| Four metre gait speed (4MGS) | 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) |
| Questionnaires assessing gastrointestinal symptoms | To be performed at baseline visit and at 4 month visit | 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 |
Countries
United Kingdom
Contacts
Primary ContactJessica Dr Raja
Backup ContactElisabetta Professor Renzoni
Outcome results
None listed