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

This study is currently recruiting participants.
Verified February 2013 by Inova Health Care Services
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: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Each Patient Serves as His/Her Own Control.
 Behavioral: alternative instruction in exercise testing (6MWT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Alternative Instruction in Six Minute Walk Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • heart rate recovery at one minute [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Advanced Lung Disease
subjects will be enrolled with advanced lung disease and each will undergo 2-4 6MWT with variable instructions. Single arm study
 Behavioral: alternative instruction in exercise testing (6MWT)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789996

Contacts
Contact: Edwinia Battle 7037763067

Locations
United States, Virginia
Inova Advanced Lung Disease and Transplant Program Recruiting
Falls Church, Virginia, United States, 22042
Contact: Nargues Weir, MD     703-776-2986     nargues.weir@inova.org    
Sponsors and Collaborators
Inova Health Care Services
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Director: Steven D Nathan, MD Inova Advanced Lung Disease and Transplant Program
  More Information

No publications provided

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01789996     History of Changes
Other Study ID Numbers: 10.089
Study First Received: February 9, 2013
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
6 minute walk test
idiopathic pulmonary fibrosis
pulmonary arterial hypertension
interstitial lung disease

ClinicalTrials.gov processed this record on May 16, 2013