NCT02445157

Brief Summary

This study is investigating the reliability of the 4 metre gait speed test (4MGS) in patients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

6 months

First QC Date

May 1, 2015

Last Update Submit

October 26, 2015

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Gait speedFunctional outcome measure

Outcome Measures

Primary Outcomes (1)

  • 4 metre gait speed

    Measure of usual walking speed

    Change in gait speed measured at two timepoints one week apart

Study Arms (1)

IPF_Reliability

Patients diagnosed with IPF according to NICE guidelines.

Other: 4MGS

Interventions

4MGSOTHER

Measurement of usual gait speed over 4 metres (metres/second)

Also known as: 4 metre gait speed test
IPF_Reliability

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with IPF according to NICE guidelines

You may qualify if:

  • IPF diagnosis according to NICE guidelines
  • Provision of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • William DC Man, MD, PhD

    Royal Brompton and Harefield NHS Foundtion Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 15, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

GB(1)