Clinical trial NCT03916952: The Effects of Guarding on the Outcomes of the Six Minute Walk Test
Official title: The Effects of Guarding on the Outcomes of the Six Minute Walk Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Capacity
Physical Activity
Rehabilitation
Lead sponsor: Concordia University, St. Paul
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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).

Primary outcomes:
measure: Distance Walked
timeFrame: 6 Minutes
measure: Gait Speed
timeFrame: 6 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chester
country: United States
facility: Widener University
state: Pennsylvania
Study officials:
References:
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