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The Six Minute Walk Test: Influence of Instruction on Results

Sponsor
Inova Health Care Services (Other)
Overall Status
Completed
CT.gov ID
NCT01789996
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
45
Enrollment
1
Location
2
Arms
54
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: alternative six minute walk test
  • Procedure: Standard six minute walk test
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Alternative Instruction in Six Minute Walk Test (6MWT)
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Alternative six minute walk test

Subjects will be given the following instructions walk as fast as they can in 6 minutes walk as normally as they can in 6 minutes 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 walk as fast as they can in 6 minutes walk as normally as they can in 6 minutes walk leisurely as they can in 6 minutes. Pts will serve as their own controls.
Other Names:
  • 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 Names:
  • far

    		•

    Outcome Measures

    Primary Outcome Measures

    1. distance meters [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

    1. oxygen saturation [1 day]

      assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day

    2. dyspnea score [1 day]

      assessed as an outcome of variable instruction given in different six minute

    3. heart rate response [1 day]

      assessed as an outcome of variable instruction given in different six minute

    Other Outcome Measures

    1. heart rate recovery at one minute [1 day]

      assessed as an outcome of variable instruction given in different six minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT01789996
    Other Study ID Numbers:
    • 10.089
    First Posted:
    Feb 12, 2013
    Last Update Posted:
    Jun 16, 2020
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Jun 16, 2020