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

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Other: 4 metre gait speed

Study type: Observational

Funder types: Other

Identifiers

NCT02530736

14/LO/2247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

IPF_RESP

Description:

Pulmonary Rehabilitation: a 6 - 8 week exercise and education programme (this is part of usual care)

Treatment:

Other: 4 metre gait speed