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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Inova Health Care Services.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01789996
First received: February 9, 2013
Last updated: March 23, 2015
Last verified: March 2015
February 9, 2013
March 23, 2015
June 2010
November 2016   (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 ]
  • heart rate response [ Time Frame: 1 day ]
Same as current
heart rate recovery at one minute [ Time Frame: 1 day ]
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
Interventional
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):1900-1905. 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.
 
Unknown status
45
December 2016
November 2016   (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
Not Provided
Not Provided
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
March 2015

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