Reliability of the 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis (IPFREL)

October 26, 2015 updated by: Royal Brompton & Harefield NHS Foundation Trust

Reliability of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis

This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This observational study is investigating a simple test of walking speed, measured using the 4 metre gait speed test (4MGS), 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 is a reliable measure in patients with IPF as this will help inform us of its potential use 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). Participants will be asked to do this twice with a rest in between if required. One week later, participants will be asked to repeat the walking tests again.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with IPF according to NICE guidelines

Description

Inclusion Criteria:

  • IPF diagnosis according to NICE guidelines
  • Provision of 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IPF_Reliability
Patients diagnosed with IPF according to NICE guidelines.
Other: 4MGS
Measurement of usual gait speed over 4 metres (metres/second)
Other Names:
  • 4 metre gait speed test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4 metre gait speed
Time Frame: Change in gait speed measured at two timepoints one week apart
Measure of usual walking speed
Change in gait speed measured at two timepoints one week apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: William DC Man, MD, PhD, Royal Brompton and Harefield NHS Foundtion Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/LO/2248

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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