Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001282370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
8/10/2026
Date registered
Help: Date registered
27/10/2026
Date last updated
Help: Date last updated
27/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
27/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Physiological response of rowers during a regatta
Scientific title
Physiological response of rowers during a regatta
Additional trial identifiers [1] 318611 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Heat illness 343813 0
Condition category
Condition code
Injuries and Accidents 339954 339954 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
The core temperature (primary outcome) response of rowers will be observed during at least 4 real-world all-day regattas in New South Wales and Queensland. Each regatta is scheduled as an all-day event, however, every participant participates for a different length of time depending on their competition schedule. The total time length of the study will be based upon the scheduling of regattas and therefore, when the research team has access to the prospective participants.

The rowers will be supplied an ingestible core temperature sensor prior to competition via postal mail, which will provide wireless data readings to the research team throughout the day of the regatta. The participants will be required to consume the sensor at least 6 hours prior to the start of the regatta, as per routine protocol in the scientific literature.

The participants will not be asked to change any of their behaviour during the regatta, and will only be asked to provide a written diary of their activities during the day and to meet the research team at regular intervals on-site in order to download the wireless data. The diary will feature
details such as:
-Detail any cooling strategies (i.e. cold water consumption, ice towels, fans, seeking shade) that you have used during the regatta.
-Detail when and how much fluid you have consumed.
-Detail your pre-race warm-up routine.
-Detail what times you had races
-provide an outline of the types of activities that you completed in-between races.

A sport science University student will lead data collection, and the remainder of the team are experienced researchers with 10-30 years of academic experience or relevent rowing organisation members.
Intervention code [1] 335517 0
Not applicable
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 347125 0
Core temperature
Timepoint [1] 347125 0
Monitored continuously during the entire duration across the sessions. An ingestible sensor is consumed 6-8 hours prior to each session. Each regatta session will be of a varied length depending on the competition involvement of each individual.
Secondary outcome [1] 469017 0
Performance data
Timepoint [1] 469017 0
During the regatta at irregular intervals (~every 2 hours). Each regatta session will be of a varied length depending on the competition involvement of each individual.
Secondary outcome [2] 469018 0
Body mass loss
Timepoint [2] 469018 0
During the regatta at feasible irregular intervals (~every 2 hours). Each regatta session will be of a varied length depending on the competition involvement of each individual.
Secondary outcome [3] 469444 0
Activity performed during a warm-up prior to each race
Timepoint [3] 469444 0
-Noted in a diary continuously during the day

Eligibility
Key inclusion criteria
-Registered competitior at a rowing regatta organised by Rowing NSW or Rowing Australia.
-Male or female
-18 years to 65 years old
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria:
People weighing less than 40 kg.
People with or presenting a risk of intestinal disorders that can lead to obstruction of the digestive tract, including diverticula.
People with motility disorders of the gastrointestinal tract.
People who have undergone surgical procedures in the gastrointestinal tract.
People with known swallowing disorders.
People who have to undergo strong electromagnetic field during the period of use of the system (MRI particular).
Pregnant women.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
-Core temperature values will be descriptively plotted against the relevant environmental risk (for heat illness) ratings, as indicated by the extreme heat policy.
-Linear mxed models will determine whether the core temperature response statistically differs between the environmental risk ratings (low, moderate, high, extreme risk) that are indicated by the extreme heat policy.
-The primary research does not lend itself to a formal power calculation, which is to determine the appropriatness of the descriptive terms for heat illness risk (low, moderate, high, extreme) against the associated core temperature response during regatta days that correspond to different risk levels. There is no formal method for doing this other than describing how the average core temperature response per risk bracket compares against known criticial core temperature thresholds that are typically associated with elevated risk. Overall, our anticipated sample size
meets precedents that is expected in similar lines of research.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/12/2026
Actual
Date of last participant enrolment
Anticipated
27/03/2028
Actual
Date of last data collection
Anticipated
3/04/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 323185 0
Commercial sector/Industry
Name [1] 323185 0
Rowing Australia
Country [1] 323185 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 326156 0
None
Name [1] 326156 0
Address [1] 326156 0
Country [1] 326156 0
Other collaborator category [1] 284135 0
University
Name [1] 284135 0
University of Canberra
Address [1] 284135 0
Country [1] 284135 0
Australia
Other collaborator category [2] 284136 0
University
Name [2] 284136 0
The University of Sydney
Address [2] 284136 0
Country [2] 284136 0
Australia
Other collaborator category [3] 284137 0
Commercial sector/Industry
Name [3] 284137 0
Rowing New South Wales
Address [3] 284137 0
Country [3] 284137 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321591 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 321591 0
Ethics committee country [1] 321591 0
Australia
Date submitted for ethics approval [1] 321591 0
Approval date [1] 321591 0
20/12/2024
Ethics approval number [1] 321591 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154182 0
Dr Samuel Chalmers
Address 154182 0
Adelaide University, Level 2, South Australian Sports Institute (SASI) Building, 145B Railway Terrace, Mile End SA 5031.
Country 154182 0
Australia
Phone 154182 0
+61 08 8302 1307
Fax 154182 0
Email 154182 0
[email protected]
Contact person for public queries
Name 154183 0
Samuel Chalmers
Address 154183 0
Adelaide University, Level 2, South Australian Sports Institute (SASI) Building, 145B Railway Terrace, Mile End SA 5031.
Country 154183 0
Australia
Phone 154183 0
+61 08 8302 1307
Fax 154183 0
Email 154183 0
[email protected]
Contact person for scientific queries
Name 154184 0
Samuel Chalmers
Address 154184 0
Adelaide University, Level 2, South Australian Sports Institute (SASI) Building, 145B Railway Terrace, Mile End SA 5031.
Country 154184 0
Australia
Phone 154184 0
+61 08 8302 1307
Fax 154184 0
Email 154184 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.