The predictive ability of 4MGS in IPF
Research type
Research Study
Full title
Does 4 metre gait speed (4MGS) predict mortality and non-elective hospitalisation in patients with idiopathic pulmonary fibrosis (IPF)?
IRAS ID
167405
Contact name
William Man
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
This study is investigating a simple test of usual walking speed, measured using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess the effectiveness of treatment. Death and hospital admissions are currently considered meaningful endpoints in research trials due to the lack of fully validated surrogate endpoints in IPF. Using surrogate endpoints could reduce the sample size, cost and duration of clinical trials in IPF perhaps permitting more rapid drug development. Slow walking speed has been shown to be consistently associated with survival and a risk factor for disability, institutionalisation and hospitalisation in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD). We are interested to see whether usual walking speed and change in usual walking speed over 6 months predicts death and hospital admissions in IPF patients. This will help inform us of the potential use of 4MGS as a surrogate endpoint. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet) at one time point and then six months later.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0015
Date of REC Opinion
19 Jan 2015
REC opinion
Favourable Opinion