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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Inova Health Care Services
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Steven D Nathan, MD Inova Advanced Lung Disease and Transplant Program
  More Information

No publications provided by Inova Health Care Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 25, 2014