A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Interventions, No intervention.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other No Interventions
No intervention - Other No intervention
No intervention
Primary outcome measures
- Recruitment of patients to study [Time frame: For study recruitment window of 6 months]
- Implementation of study protocol [Time frame: For the 6 month recruitment window]
- Feasibility of collection of data [Time frame: For the the study recruitment window of 6 months]
- Acceptability of use of BIA and muscle ultrasound [Time frame: To be performed at baseline visit and 4 month visit]
Secondary outcome measures (10)
- Bioelectrical impedance analysis (BIA) [Time frame: Performed at baseline visit and at 4 month visit]
- Five times sit to stand (5TST) [Time frame: To be performed at baseline visit and at 4 month visit]
- Four metre gait speed (4MGS) [Time frame: To be performed at baseline visit and 4 month visit]
- Questionnaires assessing gastrointestinal symptoms [Time frame: To be performed at baseline visit and at 4 month visit]
- Questionnaires assessing respiratory symptoms and quality of life [Time frame: To be performed at baseline visit and at 4 month visit]
- Questionnaire to assess levels of physical activity [Time frame: To be performed at baseline visit and at 4 month visit]
- Muscle strength [Time frame: Performed at baseline visit and 4 month visit]
- Height [Time frame: To be performed at baseline]
- Body weight [Time frame: Performed at baseline visit and 4 month visit]
- Quadriceps ultrasound [Time frame: To be performed at baseline visit and 4 month visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Royal Brompton Hospital — London
Identifiers
NCT: NCT07332117 · IRAS ID: 358410