Responsiveness and MID of 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis

NCT02530736 | Completed

• 1 other identifier: 14/LO/2247
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study measures the 4 metre gait speed (4MGS) test in patients with Idiopathic Pulmonary Fibrosis (IPF). The investigators are interested to see whether usual walking speed in IPF patients changes following pulmonary rehabilitation and if it changes, what is the smallest change that is meaningful to patients.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Gait speed; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in usual walking speed measured using the 4 metre gait speed test

  A measure of usual walking speed

  Change from baseline to 8 weeks

Study Arms (1)

IPF_RESP

Pulmonary Rehabilitation: a 6 - 8 week exercise and education programme (this is part of usual care)

Other: 4 metre gait speed

Interventions

4 metre gait speed OTHER

Measurement of usual walking speed over 4 metres. Change in walking speed is measured at baseline (pre-pulmonary rehabilitation assessment) and 8 weeks later (post-pulmonary rehabilitation assessment)

Also known as: 4MGS

IPF_RESP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guideliness referred for Pulmonary Rehabilitation

You may qualify if:

• Patients diagnosed with Idiopathic Pulmonary Fibrosis according to NICE guidelines referred for Pulmonary Rehabilitation
• Provided 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28883090 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William DC Man, MD, PhD

  Royal Brompton and Harefield NHS Foundation 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: August 21, 2015
• Study Start: February 1, 2015
• Primary Completion: October 17, 2016
• Study Completion: October 18, 2017
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)