NCT06685627

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2020

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

5 years

First QC Date

November 11, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

Core temperaturewaterswimwetsuitcold

Outcome Measures

Primary Outcomes (1)

  • Core temperature

    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.

    The thermistor was inserted 15 minutes prior to immersion and measured the core temperature until 30 minutes after egress from the water.

Interventions

All swimmers used their own well-fitting wetsuits (5 mm maximum thickness in accordance with World Triathlon guidelines7) and were free to supplement additional neoprene hats, gloves and booties as desired. A safety paramedic attended all swims. Swim distance was self-determined

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trained and highly trained swimmers were recruited from local swim clubs and via social media

You may qualify if:

  • Trained and highly trained swimmers.

You may not qualify if:

  • a history of cardiovascular disease, arrhythmias, or gastrointestinal abnormalities precluding the use of rectal temperature measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Clinical Medicine, University of Oslo, Oslo, Norway

Olso, Olso, Norway

Location

Related Publications (1)

  • Morton WJ, Melau J, Olsen RA, Lovvik OM, Hisdal J, Sovik S. Thermal physiology of open water wetsuited swimming: A cohort study. Temperature (Austin). 2025 Mar 24;12(3):245-263. doi: 10.1080/23328940.2025.2479893. eCollection 2025.

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Jonny Hisdal, PhD

    Institute of Clinical Medicine, University of Oslo, Oslo, Norway

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 12, 2024

Study Start

October 27, 2015

Primary Completion

October 18, 2020

Study Completion

October 18, 2020

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

IPD will be shared upon request from a validated body and subject to a data sharing agreement with the University of Oslo.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD and supporting data will be available from publication of the primary outcome data in a peer review journal and will be supported for 10 years form that date.
Access Criteria
IPD will be shared upon request from a validated body and subject to a data sharing agreement with the University of Oslo.

Locations