NCT03360032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

November 27, 2017

Last Update Submit

September 26, 2019

Conditions

Keywords

Incremental shuttle walk testCardiopulmonary exercise testVO2 peak

Outcome Measures

Primary Outcomes (1)

  • VO2 peak

    Maximum oxygen consumption at peak exercise

    Measured and reported at time of test

Secondary Outcomes (1)

  • PO2

    Measured and reported at time of test

Study Arms (1)

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.

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Coventry, Warwickshire, CV2 2DX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • David Parr

    University Hospitals Coventry and Warwickshire NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

January 10, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations