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Clinical Trials/NCT03360032
NCT03360032
Unknown
Not Applicable

A Comparative Assessment of Measurements Made in an Incremental Shuttle Walk Test and Incremental Cycle Ergometry Test in Patients With Idiopathic Pulmonary Fibrosis

University Hospitals Coventry and Warwickshire NHS Trust1 site in 1 country43 target enrollmentJanuary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Pulmonary Fibrosis
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Enrollment
43
Locations
1
Primary Endpoint
VO2 peak
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2018
End Date
April 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

VO2 peak

Time Frame: Measured and reported at time of test

Maximum oxygen consumption at peak exercise

Secondary Outcomes

  • PO2(Measured and reported at time of test)

Study Sites (1)

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