The Six Minute Walk Test: Influence of Instruction on Results

Interstitial Lung Disease Clinical Trial

Official title:

Alternative Instruction in Six Minute Walk Test (6MWT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789996
• Other study ID #: 10.089
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two - four 6MWT performed according to ATS standards. Each walk however had specifically altered wording and coaching performed in random order to determine differences in outcomes. One walk was done in the standard ATS fashion. One was done coaching to walk as fast as the patient can walk. One was coached to walk at the patients normal walking pace. One was coached to walk at the patient's leisure walking pace.

Description:

Alternate 6MWT where subjects will be asked to walk as fast as they can, walk as normal as they can and walk leisurely as they can in 6 minutes compared to standard of care 6MWT which is walk as far as you can in 6 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• advanced lung disease such as COPD, ILD, IPF, or PAH

Exclusion Criteria:

• inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Procedure:
• alternative six minute walk test
Alternate instructions will be given Subjects will walk as fast as they can in 6 minutes walk as normally as they can in 6 minutes walk leisurely as they can in 6 minutes. Pts will serve as their own controls.
• Standard six minute walk test
Subjects will walk as far as they can in 6 minutes

Locations

Country	Name	City	State
United States	Inova Advanced Lung Disease and Transplant Program	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	heart rate recovery at one minute	assessed as an outcome of variable instruction given in different six minute	1 day
Primary	distance meters	this is an ongoing study of same day testing of 2-4 six minute walk tests, each with different instructions, to determine the impact of alternative instruction on outcome of the test	1 day
Secondary	oxygen saturation	assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day	1 day
Secondary	dyspnea score	assessed as an outcome of variable instruction given in different six minute	1 day
Secondary	heart rate response	assessed as an outcome of variable instruction given in different six minute	1 day