The Six Minute Walk Test: Influence of Instruction on Results

NCT01789996 | Completed

• 1 other identifier: 10.089
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

6 minute walk test; idiopathic pulmonary fibrosis; pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• oxygen saturation

  1 day

• dyspnea score

  1 day

• heart rate response

  1 day

Other Outcomes (1)

• heart rate recovery at one minute

  1 day

Study Arms (2)

Alternative six minute walk test

ACTIVE COMPARATOR

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

Standard six minute walk test

PLACEBO COMPARATOR

Subjects will be given the following instruction 1\. walk as far as they can in 6 minutes

Procedure: Standard six minute walk test

Interventions

alternative six minute walk test PROCEDURE

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.

Also known as: fast vs far

Alternative six minute walk test

Standard six minute walk test PROCEDURE

Subjects will walk as far as they can in 6 minutes

Also known as: far

Standard six minute walk test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• advanced lung disease such as COPD, ILD, IPF, or PAH

You may not qualify if:

• inability to walk, requiring supplemental oxygen, cardiac disease preventing successful 6MWT

Sponsors & Collaborators

• Inova Health Care Services: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Inova Advanced Lung Disease and Transplant Program

Falls Church, Virginia, 22042, United States

Location

Related Publications (1)

• 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.

  PMID: 23975232 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Pulmonary Arterial Hypertension

Interventions

Mutation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Hypertension, Pulmonary

Intervention Hierarchy (Ancestors)

Genetic Variation; Genetic Phenomena

Study Officials

• Steven D Nathan, MD

  Inova Advanced Lung Disease and Transplant Program

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2013
• First Posted: February 12, 2013
• Study Start: June 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 16, 2020

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)