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

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ClinicalTrials.gov Identifier: NCT02530736
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: 4 metre gait speed

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Responsiveness of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis and Determination of the Minimum Important Difference
Study Start Date : February 2015
Actual Primary Completion Date : October 17, 2016
Actual Study Completion Date : October 18, 2017


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 Name: 4MGS




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guideliness referred for Pulmonary Rehabilitation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530736


Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
Harefield, Middlesex, United Kingdom, UB9 6JH
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: William DC Man, MD, PhD Royal Brompton and Harefield NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02530736    
Other Study ID Numbers: 14/LO/2247
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Gait speed
Pulmonary Rehabilitation
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial