The Effects of Guarding on the Outcomes of the Six Minute Walk Test
1 other identifier
observational
205
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2018
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedApril 16, 2019
April 1, 2019
1.5 years
April 12, 2019
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
Healthy older
All participants \> 65 years of age that completed the test
Interventions
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.
Eligibility Criteria
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
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: 20525717BACKGROUNDBohannon 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: 27592691BACKGROUNDWise 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: 17136972BACKGROUNDBohannon 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: 9143432BACKGROUNDChetta 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: 16466676BACKGROUNDSteffen 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: 11856064BACKGROUNDBland 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: 17613642BACKGROUNDCicchetti 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: 16909062BACKGROUNDStevens 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: 10556117BACKGROUNDde 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: 19961638BACKGROUNDBansal 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: 18263673BACKGROUNDSmith 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: 20206529BACKGROUNDLederer 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: 16778159BACKGROUNDVanWagner 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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