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The Six Minute Walk Test: Influence of Instruction on Results

This study has been completed.
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: August 15, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention
Interstitial Lung Disease Procedure: alternative six minute walk test Procedure: Standard six minute walk test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Alternative Instruction in Six Minute Walk Test (6MWT)

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • heart rate recovery at one minute [ Time Frame: 1 day ]
    assessed as an outcome of variable instruction given in different six minute


Enrollment: 45
Study Start Date: June 2010
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Placebo Comparator: Standard six minute walk test

Subjects will be given the following instruction

1. walk as far as they can in 6 minutes

Procedure: Standard six minute walk test
Subjects will walk as far as they can in 6 minutes
Other Name: far

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Virginia
Inova Advanced Lung Disease and Transplant Program
Falls Church, Virginia, United States, 22042
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

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: August 15, 2017
Individual Participant Data (IPD) Sharing Statement:
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.

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 21, 2017