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

Completed

• Conditions: Rehabilitation; Functional Capacity; Physical Activity
• Interventions: Diagnostic Test: Six Minute Walk Test

• Registration Number: NCT03916952
• Lead Sponsor: Concordia University, St. Paul

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.

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 Timeline

• Study Start: 2017-06-11
• Primary Completion: 2018-12-12
• Study Completion: 2018-12-12
• Status Verified: 2019-04
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-15
• Last Update Submitted: 2019-04-15
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy younger	Six Minute Walk Test	All participants between 18 and 65 years of age that completed the test
Healthy older	Six Minute Walk Test	All participants \> 65 years of age that completed the test

Primary Outcome Measures

Name	Time	Method
Gait Speed	6 Minutes	How fast the patient was able to ambulate
Distance Walked	6 Minutes	How far the patient was able to ambulate

Trial Locations

Locations (1)

Widener University; 🇺🇸 Chester, Pennsylvania, United States