Health TrialsbyHealthPanel

A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications

ConditionsIdiopathic Pulmonary Fibrosis (IPF)Progressive Pulmonary Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust

About this trial

To assess the impact on body mass composition from anti-fibrotic medications used in fibrotic lung disease by using BIA and muscle ultrasound

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Patients being newly commenced on anti-fibrotic medication as part of their clinical care (either nintedanib or pirfenidone)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • No Interventions

    Other intervention

    No intervention

  • No intervention

    Other intervention

    No intervention

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Patients to be commenced on anti-fibrotics2 interventions
Group B: Control group2 interventions

Trial outcomes

Primary outcomes

1

Recruitment 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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

Four metre gait speed (4MGS)

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 4 month visit
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Brompton & Harefield NHS Foundation Trust

Lead sponsor

Source ClinicalTrials.gov
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