The Six Minute Walk Test: Influence of Instruction on Results

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Alternative Instruction in Six Minute Walk Test (6MWT)

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Procedure: alternative six minute walk test
* Procedure: Standard six minute walk test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alternative six minute walk test<br>Subjects will be given the following instructions 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. | Procedure: alternative six minute walk test<br>* 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.<br>* Other names: fast vs far;|
| Placebo Comparator: Standard six minute walk test<br>Subjects will be given the following instruction 1. walk as far as they can in 6 minutes | Procedure: Standard six minute walk test<br>* Subjects will walk as far as they can in 6 minutes<br>* Other names: far;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| dyspnea score | assessed as an outcome of variable instruction given in different six minute | 1 day | 
| heart rate response | assessed as an outcome of variable instruction given in different six minute | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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6 minute walk test, idiopathic pulmonary fibrosis, pulmonary arterial hypertension