The Effect of Large Versus Small Clog Size on Emergency Response Time

Study Overview
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Brief Summary
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In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly, The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed. Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course. The primary endpoint is the time taken to complete the course. The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation. The ethical committee judged the study protocol exempt from extensive review.

Official Title
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The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial

Conditions
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Clothing, Occupational Injuries

Intervention / Treatment
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* Other: Small clog size
* Other: Large clog size


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthcare workers aged 18 years or older. Exclusion Criteria: Inability to run on clogs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Small clog size<br> | Other: Small clog size<br>* Participants will be randomized to run in small clogs<br>|
| Active Comparator: Large clog size<br> | Other: Large clog size<br>* Participants will be randomized to run in large clogs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete the running course | The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates. | Follow-up until 60 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Follow-up until 60 minutes. | 
| Time to complete the running course for specific subgroups: By gender, job function, level of fitness. |  | Follow-up until 60 minutes. |