Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Six Minute Walk Test: Influence of Patient Effort on Results and Interpretation (fast vs far)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2013 by Inova Health Care Services.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Inova Health Care Services Identifier:
First received: February 9, 2013
Last updated: February 12, 2013
Last verified: February 2013

February 9, 2013
February 12, 2013
June 2010
November 2014   (final data collection date for primary outcome measure)
distance meters [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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 Archive Site
  • oxygen saturation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • heart rate response [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
heart rate recovery at one minute [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
The Six Minute Walk Test: Influence of Patient Effort on Results and Interpretation
Alternative Instruction in Six Minute Walk Test

2-4 6MWT performed but with alternative wording and coaching in random order to determine differences in outcomes.

Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Each Patient Serves as His/Her Own Control.
Behavioral: alternative instruction in exercise testing (6MWT)
Advanced Lung Disease
subjects will be enrolled with advanced lung disease and each will undergo 2-4 6MWT with variable instructions. Single arm study
Intervention: Behavioral: alternative instruction in exercise testing (6MWT)
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):1900-5. doi: 10.1378/chest.13-0287.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
18 Years to 90 Years
Contact: Edwinia Battle 7037763067
United States
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
February 2013

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