NCT03916952

Brief Summary

This study was designed to determine if walking with a healthy individual during the 6 minute walk test significantly influenced the outcome of the test.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

April 12, 2019

Last Update Submit

April 15, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Distance Walked

    How far the patient was able to ambulate

    6 Minutes

  • Gait Speed

    How fast the patient was able to ambulate

    6 Minutes

Study Arms (2)

Healthy younger

All participants between 18 and 65 years of age that completed the test

Diagnostic Test: Six Minute Walk Test

Healthy older

All participants \> 65 years of age that completed the test

Diagnostic Test: Six Minute Walk Test

Interventions

Six Minute Walk TestDIAGNOSTIC_TEST

The patients walked as far as possible for 6 minutes--over two separate trials. In one trial, an examiner walked with the participant. In the second trial, the participant walked independently. A paired T test was performed to see if there was a significant difference in the distance walked or gait speed between the trials.

Healthy olderHealthy younger

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoxes for Male, Female and Other were provided on demographic form
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was average age of 24 in the younger group and 71.2 in the older group. The population was 134 female to 69 males. The sample population was primarily Caucasian (89%). Mean BMI of the younger group was 24.1 and the older group 26.4.

You may qualify if:

  • Young Group
  • Between 18 and 50 years of age
  • Independent with ambulation such that no physical assistance was required during the 6MWT
  • No pertinent acute or chronic medical conditions.
  • Older adult group
  • years of age or older Ambulatory without requiring physical assistance Intact cognition as determined by achieving a score of 24 on the Mini Mental Status Exam
  • Stable balance by scoring a minimum of 18cm (7 inches) on the Functional Reach Test

You may not qualify if:

  • All Participants:
  • Unstable angina
  • History of myocardial infarction 30 days prior to the study
  • Resting heart rate greater than 120 beats per minute
  • Resting systolic blood pressure greater than 180 mmHg
  • Resting diastolic blood pressure greater than 100 mmHg
  • Symptoms were reported or observed that were consistent with low blood pressure
  • Recent injury, surgery or medical procedure.
  • Older Participants:
  • Functional Reach Test (\<18cm or 7 inches)
  • Mini Mental Exam (score \< 24).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Widener University

Chester, Pennsylvania, 19013, United States

Location

Related Publications (14)

  • Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.

    PMID: 20525717BACKGROUND
  • Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

    PMID: 27592691BACKGROUND
  • Wise RA, Brown CD. Minimal clinically important differences in the six-minute walk test and the incremental shuttle walking test. COPD. 2005 Mar;2(1):125-9. doi: 10.1081/copd-200050527.

    PMID: 17136972BACKGROUND
  • Bohannon RW. Comfortable and maximum walking speed of adults aged 20-79 years: reference values and determinants. Age Ageing. 1997 Jan;26(1):15-9. doi: 10.1093/ageing/26.1.15.

    PMID: 9143432BACKGROUND
  • Chetta A, Zanini A, Pisi G, Aiello M, Tzani P, Neri M, Olivieri D. Reference values for the 6-min walk test in healthy subjects 20-50 years old. Respir Med. 2006 Sep;100(9):1573-8. doi: 10.1016/j.rmed.2006.01.001. Epub 2006 Feb 7.

    PMID: 16466676BACKGROUND
  • Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.

    PMID: 11856064BACKGROUND
  • Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. doi: 10.1080/10543400701329422.

    PMID: 17613642BACKGROUND
  • Cicchetti D, Bronen R, Spencer S, Haut S, Berg A, Oliver P, Tyrer P. Rating scales, scales of measurement, issues of reliability: resolving some critical issues for clinicians and researchers. J Nerv Ment Dis. 2006 Aug;194(8):557-64. doi: 10.1097/01.nmd.0000230392.83607.c5.

    PMID: 16909062BACKGROUND
  • Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. doi: 10.1164/ajrccm.160.5.9808139.

    PMID: 10556117BACKGROUND
  • de Almeida FG, Victor EG, Rizzo JA. Hallway versus treadmill 6-minute-walk tests in patients with chronic obstructive pulmonary disease. Respir Care. 2009 Dec;54(12):1712-6.

    PMID: 19961638BACKGROUND
  • Bansal V, Hill K, Dolmage TE, Brooks D, Woon LJ, Goldstein RS. Modifying track layout from straight to circular has a modest effect on the 6-min walk distance. Chest. 2008 May;133(5):1155-60. doi: 10.1378/chest.07-2823. Epub 2008 Feb 8.

    PMID: 18263673BACKGROUND
  • Smith MD, Chang AT, Seale HE, Walsh JR, Hodges PW. Balance is impaired in people with chronic obstructive pulmonary disease. Gait Posture. 2010 Apr;31(4):456-60. doi: 10.1016/j.gaitpost.2010.01.022. Epub 2010 Mar 4.

    PMID: 20206529BACKGROUND
  • Lederer DJ, Arcasoy SM, Wilt JS, D'Ovidio F, Sonett JR, Kawut SM. Six-minute-walk distance predicts waiting list survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006 Sep 15;174(6):659-64. doi: 10.1164/rccm.200604-520OC. Epub 2006 Jun 15.

    PMID: 16778159BACKGROUND
  • VanWagner LB, Uttal S, Lapin B, Lee J, Jichlinski A, Subramanian T, Heldman M, Poole B, Bustamante E, Gunasekaran S, Tapia CS, Veerappan A, Wong SY, Levitsky J. Use of Six-Minute Walk Test to Measure Functional Capacity After Liver Transplantation. Phys Ther. 2016 Sep;96(9):1456-67. doi: 10.2522/ptj.20150376. Epub 2016 Apr 7.

    PMID: 27055540BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

June 11, 2017

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations