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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Observational
Eligible Ages 16 Years - 90 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03360032

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University Hospitals Coventry and Warwickshire NHS Trust

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
David Parr
Principal Investigator Affiliation University Hospitals Coventry and Warwickshire NHS Trust

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Idiopathic Pulmonary Fibrosis
Additional Details

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.

Contact a Trial Team

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International Sites

University Hospital, Coventry, Warwickshire, United Kingdom

Status

Recruiting

Address

University Hospital

Coventry, Warwickshire, CV2 2DX

Site Contact

David Parr

david.parr@uhcw.nhs.uk

02476 967697

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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