Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000605594
Ethics application status
Approved
Date submitted
12/04/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of humidity upon the effect of post-exercise water dousing as a potential cooling intervention
Scientific title
The role of absolute humidity upon the effect of post-exercise water dousing as a potential cooling intervention in trained long-distance runners
Secondary ID [1] 311938 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperthermia 333529 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330211 330211 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials and procedures:
- 3 x session visits to the lab by each participant in total
- 1 x familiarisation session to complete an incremental test to exhaustion. The familiarisation session will occur 4-7 days prior to the first experimental session take approximately 3hours and requires participants to complete an incremental test to exhaustion and a 10 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.
- 2 x experimental sessions to complete a 10 km time-trial on a treadmill. The dousing intervention is then applied after the completion of the time-trial during these two sessions.
- Each session will take approximately 2-3 hours and are undertaken 4-7 days apart.
- The dousing water will be administered at ~29 degrees as 1 x 400 mL douse immediately after the 10 km time trial and then followed by 4 x 200 mL douses every 6 min for a total of 30 min. The participant will place the water over their forehead whilst standing in a large bucket. After the dousing, the participant will remain seated in front of a fan that is 1.25 m away and set to 4 m/s.
- 150ml of 38 degree water will be consumed by the participant at each dousing timepoint
-A ingestible gastrointestinal temperature sensors is provided to the participants for consumption 6-8 hours prior to the two experimental sessions.

The environmental conditions for the two experimental sessions will be:
1) 30°C and 45% relative humidity (1.91 kPa absolute humidity)
2) 28.5°C and 76% relative humidity (2.96 kPa absolute humidity)

The minimum period of days that the intervention can be completed over is 11 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 University of South Australia
Intervention code [1] 328400 0
Prevention
Comparator / control treatment
Participants act as their own control in this crossover study (active control group)
Control group
Active

Outcomes
Primary outcome [1] 337963 0
Core temperature
Timepoint [1] 337963 0
Monitored continuously during the entire duration of the 10 km time trial and 30 minute recovery time for each experimental session. Core temperature will be measured via two sensors:
1) An ingestible sensor that is consumed 6-8 prior to each session (actual core temperature).
2) CALERAresearch by greenTEG device that is placed over the top of the chest (estimated coretemperature). Placed on the participant within 15 minutes prior to the time trial in each session.
Secondary outcome [1] 433906 0
Heart rate
Timepoint [1] 433906 0
Fitted within 15 minutes prior to the time-trial or incremental test to exhaustion, and then monitored continuously during the entire duration of all activities (10 km time trial, 30 minute recovery time, incremental test to exhaustion).
Secondary outcome [2] 433907 0
Thermal sensation
Timepoint [2] 433907 0
10km time trial: Baseline (start of the 10 km time trial) and every subsequent 2.5 km during the time trial in all sessions.
30 min recovery time: At baseline (0 min) and then every subsequent 6 minutes.
Secondary outcome [3] 433908 0
Thermal discomfort
Timepoint [3] 433908 0
10km time trial: Baseline (start of the 10 km time trial) and every subsequent 2.5 km during the time trial in all sessions.
30 min recovery time: At baseline (0 min) and then every subsequent 6 minutes.
Secondary outcome [4] 433909 0
Skin temperature
Timepoint [4] 433909 0
Fitted within 30 minutes prior to the time-trial and then monitored continuously during the entire duration of the 10 km time trials and 30 minute recovery time for all sessions.
Secondary outcome [5] 433910 0
Whole body sweat loss
Timepoint [5] 433910 0
Immediately before and after the time trial and the recovery 30 minutes of the cooling intervention during each session
Secondary outcome [6] 433914 0
Hydration status
Timepoint [6] 433914 0
30 minutes prior to the the 10 km time trial for all experimental sessions

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 Exercise Sport Science Australia (ESSA) pre-exercise screening tool.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed (see reasoning in the description in sequence generation entry)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Since the study is a crossover design, participants were not randomly allocated to groups, but were randomly allocated the trial order via blocked randomisation by the lead 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
Null hypothesis testing to compare the participant responses to the two dousing conditions using common statistical approaches to the Sport Science literature.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/08/2023
Date of last participant enrolment
Anticipated
5/08/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
14
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316281 0
University
Name [1] 316281 0
University of South Australia
Country [1] 316281 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 318471 0
None
Name [1] 318471 0
Address [1] 318471 0
Country [1] 318471 0
Other collaborator category [1] 283006 0
University
Name [1] 283006 0
University of Canberra
Address [1] 283006 0
Country [1] 283006 0
Australia
Other collaborator category [2] 283007 0
University
Name [2] 283007 0
The University of Sydney
Address [2] 283007 0
Country [2] 283007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315100 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 315100 0
Ethics committee country [1] 315100 0
Australia
Date submitted for ethics approval [1] 315100 0
04/05/2023
Approval date [1] 315100 0
23/05/2023
Ethics approval number [1] 315100 0
205513

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

Contacts
Principal investigator
Name 133678 0
Dr Samuel Chalmers
Address 133678 0
University of South Australia, GPO Box 2471, Adelaide, SA, 5001
Country 133678 0
Australia
Phone 133678 0
+61 08 8302 1307
Fax 133678 0
Email 133678 0
[email protected]
Contact person for public queries
Name 133679 0
Chelsea Blackman
Address 133679 0
University of South Australia, GPO Box 2471, Adelaide, SA, 5001
Country 133679 0
Australia
Phone 133679 0
+61 08 8302 1307
Fax 133679 0
Email 133679 0
[email protected]
Contact person for scientific queries
Name 133680 0
Samuel Chalmers
Address 133680 0
University of South Australia, GPO Box 2471, Adelaide, SA, 5001
Country 133680 0
Australia
Phone 133680 0
+61 08 8302 1307
Fax 133680 0
Email 133680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data may be provided for all relevant outcomes that are requested.
When will data be available (start and end dates)?
For at least 5 years following the publication in a peer-review scientific journal
Available to whom?
Other researchers can request deidentified data be made available upon request to the principle investigator.
Available for what types of analyses?
Not specific
How or where can data be obtained?
Email the primary contact of the study
Dr Samuel Chalmers
E: [email protected]


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.