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

Sponsor
Concordia University, St. Paul (Other)
Overall Status
Completed
CT.gov ID
NCT03916952
Collaborator
(none)
205
1
18
11.4

Study Details

Study Description

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 Phase
  • 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

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 :
Jun 11, 2017
Actual Primary Completion Date :
Dec 12, 2018
Actual Study Completion Date :
Dec 12, 2018

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Distance Walked [6 Minutes]

    How far the patient was able to ambulate

  2. Gait Speed [6 Minutes]

    How fast the patient was able to ambulate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Widener University Chester Pennsylvania United States 19013

Sponsors and Collaborators

  • Concordia University, St. Paul

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kristin Lefebvre, Principle investigator, Concordia University, St. Paul
ClinicalTrials.gov Identifier:
NCT03916952
Other Study ID Numbers:
  • ConcordiaUStPau
First Posted:
Apr 16, 2019
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 16, 2019