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The Predictive Ability of 4MGS in IPF

NCT ID: NCT02436278

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

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-10-20

Brief Summary

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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

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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 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.

Conditions

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Idiopathic Pulmonary Fibrosis

Keywords

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Gait speed Mortality Morbidity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IPF_MORT

Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines.

4MGS

Intervention Type OTHER

Usual walking speed measured over 4 metres

Interventions

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4MGS

Usual walking speed measured over 4 metres

Intervention Type OTHER

Eligibility Criteria

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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
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, MC, 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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15/LO/0015

Identifier Type: -

Identifier Source: org_study_id