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Responsiveness and MID of 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis

Responsiveness of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis and Determination of the Minimum Important Difference

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02530736
Acronym
IPFRESP
Enrollment
120
Registered
2015-08-21
Start date
2015-02-28
Completion date
2017-10-18
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, Pulmonary Rehabilitation

Brief summary

This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF patients changes following pulmonary rehabilitation and if it changes, what is the smallest change that is meaningful to patients.

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 effectiveness of treatment. Slow walking speed has been shown to relate to poor outcomes in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD). The investigators are interested to see whether usual walking speed in IPF patients changes following a treatment called pulmonary rehabilitation (an exercise and education programme for patients with lung disease) and if it changes, what is the smallest change that is meaningful to patients (the minimum important difference - MID). The investigators are also investigating whether the change in walking speed can predict survival, number of hospital admissions and lung disease progression. This will help inform us of the potential use of 4MGS as an outcome measure. 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) before and after a course of pulmonary rehabilitation and follow-up 1 year after completing pulmonary rehabilitation.

Interventions

OTHER4 metre gait speed

Measurement of usual walking speed over 4 metres. Change in walking speed is measured at baseline (pre-pulmonary rehabilitation assessment) and 8 weeks later (post-pulmonary rehabilitation assessment)

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

* Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines referred for Pulmonary Rehabilitation * Provided informed consent

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
Change in usual walking speed measured using the 4 metre gait speed testChange from baseline to 8 weeksA measure of usual walking speed

Countries

United Kingdom

Outcome results

None listed

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