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The Six Minute Walk Test: Influence of Instruction on Results

Primary Purpose

Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
alternative six minute walk test
Standard six minute walk test
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring 6 minute walk test, idiopathic pulmonary fibrosis, pulmonary arterial hypertension

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inova Advanced Lung Disease and Transplant Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Alternative six minute walk test

Standard six minute walk test

Arm Description

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.

Subjects will be given the following instruction 1. walk as far as they can in 6 minutes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

oxygen saturation
assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day
dyspnea score
assessed as an outcome of variable instruction given in different six minute
heart rate response
assessed as an outcome of variable instruction given in different six minute

Full Information

First Posted
February 9, 2013
Last Updated
June 12, 2020
Sponsor
Inova Health Care Services
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01789996
Brief Title
The Six Minute Walk Test: Influence of Instruction on Results
Official Title
Alternative Instruction in Six Minute Walk Test (6MWT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
6 minute walk test, idiopathic pulmonary fibrosis, pulmonary arterial hypertension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alternative six minute walk test
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard six minute walk test
Arm Type
Placebo Comparator
Arm Description
Subjects will be given the following instruction 1. walk as far as they can in 6 minutes
Intervention Type
Procedure
Intervention Name(s)
alternative six minute walk test
Other Intervention Name(s)
fast vs far
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard six minute walk test
Other Intervention Name(s)
far
Intervention Description
Subjects will walk as far as they can in 6 minutes
Primary Outcome Measure Information:
Title
distance meters
Description
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
Time Frame
1 day
Secondary Outcome Measure Information:
Title
oxygen saturation
Description
assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day
Time Frame
1 day
Title
dyspnea score
Description
assessed as an outcome of variable instruction given in different six minute
Time Frame
1 day
Title
heart rate response
Description
assessed as an outcome of variable instruction given in different six minute
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
heart rate recovery at one minute
Description
assessed as an outcome of variable instruction given in different six minute
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Nathan, MD
Organizational Affiliation
Inova Advanced Lung Disease and Transplant Program
Official's Role
Study Director
Facility Information:
Facility Name
Inova Advanced Lung Disease and Transplant Program
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We found that when the instruction was given to walk as fast as they can in six minutes, the distance was statistically greater than when the instruction was to walk as far as they can in six minutes. THe other instructions given yielded no difference in outcome. Other measures such are heart rate, Borg dyspnea score and saturation were not as statistically significant.
Citations:
PubMed Identifier
23975232
Citation
Weir NA, Brown AW, Shlobin OA, Smith MA, Reffett T, Battle E, Ahmad S, Nathan SD. The influence of alternative instruction on 6-min walk test distance. Chest. 2013 Dec;144(6):1900-1905. doi: 10.1378/chest.13-0287.
Results Reference
derived

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The Six Minute Walk Test: Influence of Instruction on Results

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