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Functional CapacityNCT03916952

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

An observational study of Functional Capacity and Physical Activity, run by Concordia University, St. Paul at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Six Minute Walk Test
How many people
205 participants
Where
1 siteUnited States
Study dates
11 Jun 2017to 12 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Widener University

    Chester, Pennsylvania, 19013

Other trials in United States

About this study

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.

Read the detailed 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.

Being tested
Six Minute Walk Test
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03916952
Study groupRoleWhat they receive
Healthy youngerAll participants between 18 and 65 years of age that completed the test
Receives: Diagnostic Test: Six Minute Walk Test
Healthy olderAll participants > 65 years of age that completed the test
Receives: Diagnostic Test: Six Minute Walk Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distance Walked

    How far the patient was able to ambulate

    Measured: 6 Minutes

  2. Gait Speed

    How fast the patient was able to ambulate

    Measured: 6 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start11 Jun 2017
  3. Primary completion12 Dec 2018
  4. Study completion12 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03916952
Sponsor's protocol ID
ConcordiaUStPau
Status last verified
Apr 2019
First submitted
12 Apr 2019
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20525717

  • 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.

    PubMed 27592691

  • 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.

    PubMed 17136972

  • 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.

    PubMed 9143432

  • 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.

    PubMed 16466676

  • 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.

    PubMed 11856064

  • 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.

    PubMed 17613642

  • 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.

    PubMed 16909062

  • 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.

    PubMed 10556117

  • 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.

    PubMed 19961638

  • 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.

    PubMed 18263673

  • 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.

    PubMed 20206529

  • 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.

    PubMed 16778159

  • 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.

    PubMed 27055540

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Capacity and Physical Activity, run by Concordia University, St. Paul at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distance Walked (time frame: 6 Minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03916952, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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