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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Other: 4 metre gait speed

• Registration Number: NCT02530736
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-05-01
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Primary Completion: 2016-10-17
• Study Completion: 2017-10-18
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IPF_RESP	4 metre gait speed	Pulmonary Rehabilitation: a 6 - 8 week exercise and education programme (this is part of usual care)

Primary Outcome Measures

Name	Time	Method
Change in usual walking speed measured using the 4 metre gait speed test	Change from baseline to 8 weeks	A measure of usual walking speed

Trial Locations

Locations (1)

Royal Brompton and Harefield NHS Foundation Trust; 🇬🇧 Harefield, Middlesex, United Kingdom