- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06685627
Core Temperature in Open Water Wetsuited Swimming.
Core Temperature in Open Water Wetsuited Swimming: a Cohort Study
Swimming in cold water is intrinsically unsafe. One of the threats is a fall in core body temperature (Tcore), which adversely affects all body systems and increases the risk of death. Wetsuits mitigate, but do not negate this threat. Environmental conditions may confound findings from laboratory studies or computer models, thus necessitating open water studies.
This study was designed to investigate the effects of open water wetsuited swimming on core body temperature at a range of different water temperatures between 8.4oC and 24.5oC.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Olso, Norway
- Institute of Clinical Medicine, University of Oslo, Oslo, Norway
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Trained and highly trained swimmers.
Exclusion Criteria:
- a history of cardiovascular disease, arrhythmias, or gastrointestinal abnormalities precluding the use of rectal temperature measurement.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Core temperature
Time Frame: The thermistor was inserted 15 minutes prior to immersion and measured the core temperature until 30 minutes after egress from the water.
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A self-inserted rectal pill was used to continuously measure core temperature in 76 open water swims by 31 wetsuited swimmers in water temperatures ranging from 8.4°C to 24.5°C.
The Tcore curves were analysed by linear mixed model regression.
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The thermistor was inserted 15 minutes prior to immersion and measured the core temperature until 30 minutes after egress from the water.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jonny Hisdal, PhD, Institute of Clinical Medicine, University of Oslo, Oslo, Norway
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Akershus Universitetssykehus
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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