The Effects of Guarding on the Outcomes of the Six Minute Walk Test

Physical Activity Clinical Trial

Official title:

The Effects of Guarding on the Outcomes of the Six Minute Walk Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916952
• Other study ID #: ConcordiaUStPau
• Status: Completed
• Start date: June 11, 2017
• Est. completion date: December 12, 2018

Study information

• Verified date: April 2019
• Source: Concordia University, St. Paul
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Introduction: The American Thoracic Society recommends not walking with the patient or client during the Six Minute Walk Test (6MWT). However, this recommendation raises safety concerns for individuals at increased risk of falls. Given the recommendations and concerns, the effects of guarding during the 6MWT has not been investigated. Purpose: The purpose of this study was to determine if guarding during the 6MWT affected gait speed and distance walked. Methods: Participants were randomized into a 'guarded first' vs 'guarded second' condition. Data were analyzed using a one-sample t-test, Pearson Correlation Coefficients, Intraclass Correlation Coefficients (ICC), and Bland Altman plots to assess differences and relationships for gait speed and distance walked between the guarded and unguarded trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• 50 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Functional Capacity
• Physical Activity
• Rehabilitation

Intervention

Diagnostic Test:
• Six Minute Walk 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.

Locations

Country	Name	City	State
United States	Widener University	Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Concordia University, St. Paul

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat. 2007;17(4):571-82. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Feb 7. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jun 15. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Walked	How far the patient was able to ambulate	6 Minutes
Primary	Gait Speed	How fast the patient was able to ambulate	6 Minutes