Idiopathic Pulmonary FibrosisIPFMORTNCT02436278
The Predictive Ability of 4MGS in IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- 4MGS
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to 20 Oct 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with IPF according to NICE guidelines
Who may be able to join
- IPF diagnosis according to NICE guidelines
Who cannot join
- Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
- Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease)
- Any condition that precludes providing informed consent e.g. cognitive impairment or poor English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
Harefield, Middlesex, UB9 6JH
About this study
Official title: Does 4 Metre Gait Speed (4MGS) Predict Mortality and Non-elective Hospitalisation in Patients With Idiopathic Pulmonary Fibrosis (IPF)?
This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.
Read the detailed description
This observational study is investigating a simple test of usual walking speed, measured using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess the effectiveness of treatment. Death and hospital admissions are currently considered meaningful endpoints in research trials due to the lack of fully validated surrogate endpoints in IPF. Using surrogate endpoints could reduce the sample size, cost and duration of clinical trials in IPF perhaps permitting more rapid drug development. Slow walking speed has been shown to be consistently associated with survival and a risk factor for disability, institutionalisation and hospitalisation in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD). We are interested to see whether usual walking speed and change in usual walking speed over 6 months predicts death and hospital admissions in IPF patients. This will help inform us of the potential use of 4MGS as a surrogate endpoint. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet) at one time point and then six months later. Incidence of mortality and non-elective hospital admissions will be assessed at 12 months.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- 4MGS
- Keywords
- Gait speed, Mortality, Morbidity
- 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.
4MGSOther
Usual walking speed measured over 4 metres
| Study group | Role | What they receive |
|---|---|---|
| IPF_MORT | Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines. Receives: Other: 4MGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
IPF-specific and all-cause mortality
Measured: 12 months
Secondary outcomes (1)
Non-elective hospital admissions
IPF-specific and all-cause hospital admissions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMar 2015
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- William DC Man, MC, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436278
- Sponsor's protocol ID
- 15/LO/0015
- Acronym
- IPFMORT
- Status last verified
- Nov 2017
- First submitted
- 1 May 2015
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nolan CM, Delogu V, Maddocks M, Patel S, Barker RE, Jones SE, Kon SSC, Maher TM, Cullinan P, Man WD. Validity, responsiveness and minimum clinically important difference of the incremental shuttle walk in idiopathic pulmonary fibrosis: a prospective study. Thorax. 2017 Sep 7:thoraxjnl-2017-210589. doi: 10.1136/thoraxjnl-2017-210589. Online ahead of print.
PubMed 28883090
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does 4 Metre Gait Speed (4MGS) Predict Mortality and Non-elective Hospitalisation in Patients With Idiopathic Pulmonary Fibrosis (IPF)?
- ClinicalTrials.gov ID
- NCT02436278
- Acronym / sponsor ID
- IPFMORT / 15/LO/0015
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Gait speed, Mortality, Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Mar 2015 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- 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.
This study investigates whether usual walking speed, measured by the 4 metre gait speed test (4MGS), and change in usual walking speed over 6 months predicts death and hospital admissions in patients with Idiopathic Pulmonary Fibrosis.
Detailed description
This observational study is investigating a simple test of usual walking speed, measured using the 4 metre gait speed (4MGS) test in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Drug development for this disease is slow in part because there is a lack of reliable measurements that can assess the effectiveness of treatment. Death and hospital admissions are currently considered meaningful endpoints in research trials due to the lack of fully validated surrogate endpoints in IPF. Using surrogate endpoints could reduce the sample size, cost and duration of clinical trials in IPF perhaps permitting more rapid drug development. Slow walking speed has been shown to be consistently associated with survival and a risk factor for disability, institutionalisation and hospitalisation in older adults and people with another lung disease called Chronic Obstructive Pulmonary Disease (COPD). We are interested to see whether usual walking speed and change in usual walking speed over 6 months predicts death and hospital admissions in IPF patients. This will help inform us of the potential use of 4MGS as a surrogate endpoint. To do this, participants who consent to taking part in the study will be timed walking at their usual walking speed over a distance of 4 metres (13.12 feet) at one time point and then six months later. Incidence of mortality and non-elective hospital admissions will be assessed at 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPF_MORT | – | Other: 4MGSPatients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IPF according to NICE guidelines
Key inclusion criteria (1 listed)
- IPF diagnosis according to NICE guidelines
Key exclusion criteria (3 listed)
- Significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)
- Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease)
- Any condition that precludes providing informed consent e.g. cognitive impairment or poor English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4MGSUsual walking speed measured over 4 metres | Other | IPF_MORT |
Primary outcome
Mortality
Time frame: 12 months
IPF-specific and all-cause mortality
1 secondary outcome
Non-elective hospital admissions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Derived from this study: PubMed 28883090Nolan CM, Delogu V, Maddocks M, Patel S, Barker RE, Jones SE, Kon SSC, Maher TM, Cullinan P, Man WD. Validity, responsiveness and minimum clinically important difference of the incremental shuttle walk in idiopathic pulmonary fibrosis: a prospective study. Thorax. 2017 Sep 7:thoraxjnl-2017-210589. doi: 10.1136/thoraxjnl-2017-210589. Online ahead of print.
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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.
William DC Man, MC, PhD principal investigator
Royal Brompton & Harefield NHS Foundation 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 Royal Brompton & Harefield NHS Foundation 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 9 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02436278, which also lists 1 linked publication.
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 9 Nov 2017.