The Six Minute Walk Test: Influence of Instruction on Results

Alternative Instruction in Six Minute Walk Test (6MWT)

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Procedure: alternative six minute walk test; Procedure: Standard six minute walk test

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distance meters	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen saturation	assessed as an outcome of variable instruction given in different six minute walk tests performed in random order on the same day	1 day
dyspnea score	assessed as an outcome of variable instruction given in different six minute	1 day
heart rate response	assessed as an outcome of variable instruction given in different six minute	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate recovery at one minute	assessed as an outcome of variable instruction given in different six minute	1 day

Collaborators and Investigators

• Sponsor: Inova Health Care Services
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Study Director: Steven D Nathan, MD, Inova Advanced Lung Disease and Transplant Program

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 9, 2013
• First Submitted That Met QC Criteria: February 9, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: idiopathic pulmonary fibrosis; pulmonary arterial hypertension; 6 minute walk test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 10.089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.