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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04406220
Other study ID # 2019-clog
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2020
Est. completion date April 30, 2020

Study information

Verified date May 2020
Source VU University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthcare workers aged 18 years or older.

Exclusion Criteria:

- Inability to run on clogs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Small clog size
Participants will be randomized to run in small clogs
Large clog size
Participants will be randomized to run in large clogs

Locations

Country Name City State
Netherlands Amsterdam UMC, location VUmc Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Adverse events Follow-up until 60 minutes.
Secondary Time to complete the running course for specific subgroups: By gender, job function, level of fitness. Follow-up until 60 minutes.
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