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

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ClinicalTrials.gov Identifier: NCT03916952
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kristin Lefebvre, Concordia University, St. Paul

Study Description
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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.

Condition or disease Intervention/treatment
Functional Capacity Physical Activity Rehabilitation Diagnostic Test: Six Minute Walk Test

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.
Study Design
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Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effects of Guarding on the Outcomes of the Six Minute Walk Test
Actual Study Start Date : June 11, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy younger
All participants between 18 and 65 years of age that completed the test
 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.
Healthy older
All participants > 65 years of age that completed the test
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Distance Walked [ Time Frame: 6 Minutes ]
    How far the patient was able to ambulate

  2. Gait Speed [ Time Frame: 6 Minutes ]
    How fast the patient was able to ambulate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Boxes for Male, Female and Other were provided on demographic form
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916952


Locations
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United States, Pennsylvania
Widener University
Chester, Pennsylvania, United States, 19013
Sponsors and Collaborators
Concordia University, St. Paul
More Information
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Publications:

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Responsible Party: Kristin Lefebvre, Principle investigator, Concordia University, St. Paul
ClinicalTrials.gov Identifier: NCT03916952    
Other Study ID Numbers: ConcordiaUStPau
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No