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The Six Minute Walk Test: Influence of Instruction on Results

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01789996
First Posted: February 12, 2013
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Inova Health Care Services
February 9, 2013
February 12, 2013
August 18, 2017
June 2010
November 2014   (Final data collection date for primary outcome measure)
distance meters [ Time Frame: 1 day ]
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
Same as current
Complete list of historical versions of study NCT01789996 on ClinicalTrials.gov Archive Site
  • oxygen saturation [ Time Frame: 1 day ]
    assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day
  • dyspnea score [ Time Frame: 1 day ]
    assessed as an outcome of variable instruction given in different six minute
  • heart rate response [ Time Frame: 1 day ]
    assessed as an outcome of variable instruction given in different six minute
  • oxygen saturation [ Time Frame: 1 day ]
    assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day
  • dyspnea score [ Time Frame: 1 day ]
  • heart rate response [ Time Frame: 1 day ]
heart rate recovery at one minute [ Time Frame: 1 day ]
assessed as an outcome of variable instruction given in different six minute
heart rate recovery at one minute [ Time Frame: 1 day ]
 
The Six Minute Walk Test: Influence of Instruction on Results
Alternative Instruction in Six Minute Walk Test (6MWT)
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Interstitial Lung Disease
  • Procedure: alternative six minute walk test

    Alternate instructions will be given Subjects will

    1. walk as fast as they can in 6 minutes
    2. walk as normally as they can in 6 minutes
    3. walk leisurely as they can in 6 minutes. Pts will serve as their own controls.
    Other Name: fast vs far
  • Procedure: Standard six minute walk test
    Subjects will walk as far as they can in 6 minutes
    Other Name: far
  • Active Comparator: Alternative six minute walk test

    Subjects will be given the following instructions

    1. walk as fast as they can in 6 minutes
    2. walk as normally as they can in 6 minutes
    3. walk leisurely as they can in 6 minutes. Pts will serve as their own controls.
    Intervention: Procedure: alternative six minute walk test
  • Placebo Comparator: Standard six minute walk test

    Subjects will be given the following instruction

    1. walk as far as they can in 6 minutes

    Intervention: Procedure: Standard six minute walk test
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01789996
10.089
No
Not Provided
Plan to Share IPD: Undecided
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.
Inova Health Care Services
Inova Health Care Services
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Steven D Nathan, MD Inova Advanced Lung Disease and Transplant Program
Inova Health Care Services
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP