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

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ClinicalTrials.gov Identifier: NCT02445157
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
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).

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: 4MGS

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
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reliability of the 4 Metre Gait Speed in Patients With Idiopathic Pulmonary Fibrosis
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


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 Name: 4 metre gait speed test




Primary Outcome Measures :
  1. 4 metre gait speed [ Time Frame: Change in gait speed measured at two timepoints one week apart ]
    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 IPF according to NICE guidelines
Criteria

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

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): NCT02445157


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

Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02445157     History of Changes
Other Study ID Numbers: 14/LO/2248
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Gait speed
Functional outcome measure

Additional relevant MeSH terms:
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors