Idiopathic Pulmonary FibrosisNCT03360032
Comparing Measurements Made in an Incremental Shuttle Walk Test and a Cardiopulmonary Exercise Test in Patients With IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 43 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital
Coventry, Warwickshire, CV2 2DX
David Parr, 02476 967697, david.parr@uhcw.nhs.uk
David Parr
About this study
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
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Incremental shuttle walk test, Cardiopulmonary exercise test, VO2 peak
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Maximum oxygen consumption at peak exercise
Measured: Measured and reported at time of test
Secondary outcomes (1)
PO2
Oxygen pressure in capillary blood at peak exercise
Measured: Measured and reported at time of test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start10 Jan 2018
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Parr, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360032
- Sponsor's protocol ID
- 222072
- Status last verified
- Sep 2019
- First submitted
- 27 Nov 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03360032
- Acronym / sponsor ID
- 222072
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Incremental shuttle walk test, Cardiopulmonary exercise test, VO2 peak
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VO2 peak
Time frame: Measured and reported at time of test
Maximum oxygen consumption at peak exercise
1 secondary outcome
PO2
Time frame: Measured and reported at time of test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Parr principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Parr (02476 967697, david.parr@uhcw.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 peak (time frame: Measured and reported at time of test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.