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

November 8, 2017 updated by: Royal Brompton & Harefield NHS Foundation Trust

Responsiveness of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis and Determination of the Minimum Important Difference

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

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

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guideliness referred for Pulmonary Rehabilitation

Description

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 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_RESP
Pulmonary Rehabilitation: a 6 - 8 week exercise and education programme (this is part of usual care)
Other: 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)
Other Names:
  • 4MGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in usual walking speed measured using the 4 metre gait speed test
Time Frame: Change from baseline to 8 weeks
A measure of usual walking speed
Change from baseline to 8 weeks

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 Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 17, 2016

Study Completion (Actual)

October 18, 2017

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

August 20, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/LO/2247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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