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Comparing Measurements Made in an Incremental Shuttle Walk Test and a Cardiopulmonary Exercise Test in Patients With IPF

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ClinicalTrials.gov Identifier: NCT03360032
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary:

Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF progresses, patients become increasingly breathless with reduced exercise capacity and quality of life. A cardiopulmonary exercise test (CPET) is a gold standard way of assessing patients with IPF.

An incremental shuttle walk test is simpler, cheaper, more widely available and anecdotally preferable to CPET. The investigators will compare the measurements made in an ISWT and a CPET in patients with IPF . We aim to determine whether sufficient information can be gathered in an ISWT to negate the need to undertake CPET.


Condition or disease
Idiopathic Pulmonary Fibrosis

Detailed Description:

Idiopathic pulmonary fibrosis (IPF) is a chronic and potentially fatal lung disease. As IPF progresses, patients become increasingly breathless with reduced exercise capacity and quality of life. Average life expectancy is three years from diagnosis but IPF progresses at different rates in different people. In 2012 the British Lung Foundation estimated that 32,500 in the UK had IPF.

An accurate prognosis can help determine the most appropriate individual treatment option and allow patients and their families to make suitable plans. Currently, measurements from resting lung function tests are used to predict prognosis. However, measurement made during CPET are more sensitive survival predictors and CPET is the gold standard test to assess prognosis in IPF. A CPET test is relatively time-consuming and requires specialist equipment that is not universally available. CPET is not routinely used in clinical practice for the assessment of IPF.

The incremental shuttle walk test (ISWT) is quicker, cheaper and more widely available than CPET. This study builds on previous research done by the Respiratory team which showed a linear relationship between the distance walked in an ISWT and peak oxygen consumption during a CPET, a useful prognostic predictor, in patients with interstitial lung disease. 40-50 patients with IPF will be recruited and will undertake both ISWT and CPET at University Hospital, Coventry. The investigators will compare the results in the current cohort to those of the previous study.

Additionally, the research team will compare oxygen pressure in capillary blood at the end of an ISWT and a CPET. The investigators will also compare patient experience of the two tests using questionnaires. This study paves the way for a simple, standardised test to more accurately predict prognosis in IPF.


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Study Type : Observational
Estimated Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparative Assessment of Measurements Made in an Incremental Shuttle Walk Test and Incremental Cycle Ergometry Test in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019


Group/Cohort
All participants
All patients will be asked to undertake an incremental shuttle walk test and a cardiopulmonary exercise test and the results will be compared.



Primary Outcome Measures :
  1. VO2 peak [ Time Frame: Measured and reported at time of test ]
    Maximum oxygen consumption at peak exercise


Secondary Outcome Measures :
  1. PO2 [ Time Frame: Measured and reported at time of test ]
    Oxygen pressure in capillary blood at peak exercise



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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with a confirmed diagnosis of idiopathic pulmonary fibrosis who are under the care of the Respiratory team at University Hospitals Coventry and Warwickshire NHS Trust.
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic pulmonary fibrosis confirmed by a multi-disciplinary team.
  • Aged 16 or over
  • Able to give informed consent to take part
  • Able to undertake both a cycle ergometry test and an incremental shuttle walk test without needing walking aids

Exclusion Criteria:

  • An inability to give informed consent.
  • Taking part in a research project with a potentially research-modifying intervention
  • Currently pregnant.
  • Currently breastfeeding.
  • Unable to perform an incremental shuttle walk test.
  • Unable to perform an incremental cycle ergometry test.
  • Unable to walk without an aid such as a stick or frame.

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): NCT03360032


Contacts
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Contact: David Parr 02476 967697 david.parr@uhcw.nhs.uk

Locations
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United Kingdom
University Hospital Recruiting
Coventry, Warwickshire, United Kingdom, CV2 2DX
Contact: David Parr    02476 967697    david.parr@uhcw.nhs.uk   
Principal Investigator: David Parr         
Sub-Investigator: Joanna Shakespeare         
Sub-Investigator: Elizabeth Dobson         
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
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Principal Investigator: David Parr University Hospitals Coventry and Warwickshire NHS Trust
  Study Documents (Full-Text)

Documents provided by University Hospitals Coventry and Warwickshire NHS Trust:

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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03360032     History of Changes
Other Study ID Numbers: 222072
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
Incremental shuttle walk test
Cardiopulmonary exercise test
VO2 peak
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial