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OpenTrials
Completed

NCT Number: NCT04406220

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location VUmc

Amsterdam, 1081 HV, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthcare workers aged 18 years or older.

Exclusion criteria

  • Inability to run on clogs.

Treatment and study plan

Small clog size

Other

Participants will be randomized to run in small clogs

Large clog size

Other

Participants will be randomized to run in large clogs

Primary outcomes

  1. Time to complete the running course

    Time frame: Follow-up until 60 minutes.

    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.

Secondary outcomes

  1. Adverse events

    Time frame: Follow-up until 60 minutes.

  2. Time to complete the running course for specific subgroups: By gender, job function, level of fitness.

    Time frame: Follow-up until 60 minutes.

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 28, 2020

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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