Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625001123437
Ethics application status
Approved
Date submitted
30/09/2025
Date registered
15/10/2025
Date last updated
15/10/2025
Date data sharing statement initially provided
15/10/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of cold wet towels on core temperature after long distance running in the heat
Scientific title
The effect of cold wet towels on core temperature after long distance running in the heat
Secondary ID [1] 315486 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This work is a sub-study of ACTRN12625001030460

Health condition
Health condition(s) or problem(s) studied:
High core temperature 339061 0
Condition category
Condition code
Injuries and Accidents 335338 335338 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial forms part of a larger existing study, but with independent research questions.

-Once enrolled into the study, participants will complete one familiarisation session and three experimental trials in an environmental chamber. Every session will involve only an individual participant completing the trials.

-Each experimental session will take approximately 2 to 4 hours and are undertaken 3-7 days apart.

-The familiarisation session will occur 3-7 days prior to the first experimental session and take approximately 3 hours and requires participants to complete an incremental test to exhaustion and a 5 km time trial on the treadmill. The incremental test to exhaustion will be conducted in temperate conditions (22°C and 50% relative humidity) on a calibrated motorised treadmill at 1% incline with a metabolic cart to measure gas exchange. The test will consist of initial four minute submaximal steady state exercise intensities, followed by the speed of the treadmill increasing by 1 km/h every minute until volitional exhaustion.

- The three experimental sessions require the participant to complete a running self-paced time trial on a treadmill across three distances (one per session) in warm and humid conditions (28.5°C and 76 % relative humidity);
- 5 km
- 10 km
- Half marathon

-Intervention trial: Participants will remain in the chamber for 30 min following each time-trial. Following the 10 km time-trial, participants will be seated and have 6 cold-wet towels placed around their neck, torso, arms, and legs. The towels will be made cold and wet by being placed in a bucket of water at an temperature of ~14 degrees celsius prior to application. They will drink 200mL of ~38 degrees celsius water at baseline, 10 min, and 20 min mark of the recovery period. Used towels will be rotated with new towels every 10 min by the research team. A fan will be placed in front of the participant to mimic outdoor conditions, whilst the ambient air temperature and relative humidity will remain the same as the preceding time-trials.

-Control trial: Following the 5 km and half-marathon time-trials, participants will remain seated in the chamber but without the addition of the cold-towels. They will drink 200mL of ~38 degrees celsius water at baseline, 10 min, and 20 min mark of the recovery period

The minimum period of days that the intervention can be completed over is 18 days. A study calendar will be used to manage adherence to the study sessions.

Who will deliver:
A sport science graduate will lead data collection, and the remainder of the team are experienced researchers with 10-30 years of academic experience.

Mode:
In-person testing of individual participants

Location:
Environmental chamber at the Mile End campus of Adelaide University.
Intervention code [1] 332104 0
Treatment: Other
Comparator / control treatment
Following the 5 km and half-marathon time-trials, participants will remain seated in the chamber in front of a fan (to mimic outdoor conditions) but without the addition of the cold-towels. They will drink 200mL of ~38 degrees celsius water at baseline, 10 min, and 20 min mark of the recovery period. The trial (of either the 5 km or half-marathon) which has the closest end-time trial core temperature will be matched with the 10 km intervention trial in order to form the control observation. Hence, the study is using a crossover design to investigate the independent effect of cold wet towels vs no additional intervention during recovery.
Control group
Active

Outcomes
Primary outcome [1] 342923 0
Core temperature (directly measured)
Timepoint [1] 342923 0
Monitored continuously for each experimental session duration by an ingestible sensor that is consumed 6-8 hour prior to each session.
Secondary outcome [1] 452710 0
Heart rate
Timepoint [1] 452710 0
Fitted within 15 minutes prior to the time-trial and then monitored continuously during the entire duration of each trial.
Secondary outcome [2] 452711 0
Thermal sensation
Timepoint [2] 452711 0
Baseline (at the start of the 30 min recovery period), and every 10 min of the recovery period.
Secondary outcome [3] 452712 0
Thermal discomfort
Timepoint [3] 452712 0
Baseline (at the start of the 30 min recovery period), and every 10 min of the recovery period.
Secondary outcome [4] 452713 0
Skin temperature
Timepoint [4] 452713 0
Fitted within 15 minutes prior to the time-trial and then monitored continuously during the entire duration of each each trial.
Secondary outcome [5] 452714 0
Whole body sweat loss
Timepoint [5] 452714 0
Before and after the 30 min recovery period
Secondary outcome [6] 452715 0
Core temperature (estimated)
Timepoint [6] 452715 0
Monitored continuously for the duration of each experimental session.

Eligibility
Key inclusion criteria
Trained long-distance runners who are: males and females aged between 18-55 and are training at leastthree times per week with local level representation
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not passing Stage 1 of the ESSA pre-exercise screening tool.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Since the study is a crossover design, participants are not randomly allocated to groups, but randomly allocated the trial order via blocked randomisation. Blocked randomisation (without blinding) will be completed by the lead data collector.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1) Null hypothesis testing to compare the participant responses during the intervention and control trial using common statistical approaches to the Sport Science literature.

The trial (of either the 5 km or half-marathon) which has the closest end-time trial core temperature will be matched with the 10 km intervention trial in order to form the control observation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/08/2025
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
14
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 320079 0
University
Name [1] 320079 0
Adelaide University
Country [1] 320079 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 322633 0
None
Name [1] 322633 0
Address [1] 322633 0
Country [1] 322633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318623 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 318623 0
Ethics committee country [1] 318623 0
Australia
Date submitted for ethics approval [1] 318623 0
04/05/2023
Approval date [1] 318623 0
23/07/2025
Ethics approval number [1] 318623 0

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

Contacts
Principal investigator
Name 144750 0
Dr Samuel Chalmers
Address 144750 0
Adelaide University, Level 2, SASI Building, 145B Railway Terrace, Mile End SA 5031
Country 144750 0
Australia
Phone 144750 0
+61 08 8302 1307
Fax 144750 0
Email 144750 0
[email protected]
Contact person for public queries
Name 144751 0
Mikayla Vidmar
Address 144751 0
Adelaide University, Level 2, SASI Building, 145B Railway Terrace, Mile End SA 5031.
Country 144751 0
Australia
Phone 144751 0
+61 08 8302 1307
Fax 144751 0
Email 144751 0
[email protected]
Contact person for scientific queries
Name 144752 0
Samuel Chalmers
Address 144752 0
Adelaide University, Level 2, SASI Building, 145B Railway Terrace, Mile End SA 5031
Country 144752 0
Australia
Phone 144752 0
+61 08 8302 1307
Fax 144752 0
Email 144752 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.