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

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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 43

Contacts and Locations

Study Locations

• United Kingdom
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
      • Recruiting
      • University Hospital
      • Contact: David Parr; Phone Number: 02476 967697; Email: david.parr@uhcw.nhs.uk
      • Principal Investigator: David Parr
      • Sub-Investigator: Joanna Shakespeare
      • Sub-Investigator: Elizabeth Dobson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2 peak	Maximum oxygen consumption at peak exercise	Measured and reported at time of test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PO2	Oxygen pressure in capillary blood at peak exercise	Measured and reported at time of test

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Investigators: Principal Investigator: David Parr, University Hospitals Coventry and Warwickshire NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): December 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Cardiopulmonary exercise test; Incremental shuttle walk test; VO2 peak
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 222072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No