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OpenTrials
Completed

NCT Number: NCT03916952

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Widener University

Chester, Pennsylvania, 19013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Six Minute Walk Test

Diagnostic 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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Concordia University, St. Paul

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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