Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Predictive Ability of 4MGS in IPF (IPFMORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436278
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Tracking Information
First Submitted Date May 1, 2015
First Posted Date May 6, 2015
Last Update Posted Date November 9, 2017
Actual Study Start Date March 2015
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2015)
Mortality [ Time Frame: 12 months ]
IPF-specific and all-cause mortality
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2015)
Non-elective hospital admissions [ Time Frame: 12 months ]
IPF-specific and all-cause hospital admissions
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Predictive Ability of 4MGS in IPF
Official Title Does 4 Metre Gait Speed (4MGS) Predict Mortality and Non-elective Hospitalisation in Patients With Idiopathic Pulmonary Fibrosis (IPF)?
Brief 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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients diagnosed with IPF according to NICE guidelines
Condition Idiopathic Pulmonary Fibrosis
Intervention Other: 4MGS
Usual walking speed measured over 4 metres
Study Groups/Cohorts IPF_MORT
Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines.
Intervention: Other: 4MGS
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. pii: thoraxjnl-2017-210589. doi: 10.1136/thoraxjnl-2017-210589. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2015)
132
Original Estimated Enrollment Same as current
Actual Study Completion Date October 20, 2017
Actual Primary Completion Date October 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • IPF diagnosis according to NICE guidelines

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02436278
Other Study ID Numbers 15/LO/0015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor Royal Brompton & Harefield NHS Foundation Trust
Collaborators National Institute for Health Research, United Kingdom
Investigators
Principal Investigator: William DC Man, MC, PhD Royal Brompton and Harefield NHS Foundation Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date November 2017