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

NCT ID: NCT02530736

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-10-18

Brief Summary

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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

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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Gait speed Pulmonary Rehabilitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IPF_RESP

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

4 metre gait speed

Intervention Type OTHER

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)

Interventions

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4 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)

Intervention Type OTHER

Other Intervention Names

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4MGS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William DC Man, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton and Harefield NHS Foundation Trust

Locations

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Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, United Kingdom

Site Status

Countries

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United Kingdom

References

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Nolan CM, Delogu V, Maddocks M, Patel S, Barker RE, Jones SE, Kon SSC, Maher TM, Cullinan P, Man WD. Validity, responsiveness and minimum clinically important difference of the incremental shuttle walk in idiopathic pulmonary fibrosis: a prospective study. Thorax. 2017 Sep 7:thoraxjnl-2017-210589. doi: 10.1136/thoraxjnl-2017-210589. Online ahead of print.

Reference Type DERIVED
PMID: 28883090 (View on PubMed)

Other Identifiers

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14/LO/2247

Identifier Type: -

Identifier Source: org_study_id