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The Predictive Ability of 4MGS in IPF

Does 4 Metre Gait Speed (4MGS) Predict Mortality and Non-elective Hospitalisation in Patients With Idiopathic Pulmonary Fibrosis (IPF)?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02436278
Acronym
IPFMORT
Enrollment
132
Registered
2015-05-06
Start date
2015-03-31
Completion date
2017-10-20
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Gait speed, Mortality, Morbidity

Brief summary

This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.

Detailed description

This observational 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. Incidence of mortality and non-elective hospital admissions will be assessed at 12 months.

Interventions

OTHER4MGS

Usual walking speed measured over 4 metres

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* IPF diagnosis according to NICE guidelines

Exclusion criteria

* Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation) * Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease) * Any condition that precludes providing informed consent e.g. cognitive impairment or poor English

Design outcomes

Primary

MeasureTime frameDescription
Mortality12 monthsIPF-specific and all-cause mortality

Secondary

MeasureTime frameDescription
Non-elective hospital admissions12 monthsIPF-specific and all-cause hospital admissions

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026