Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001203549
Ethics application status
Approved
Date submitted
9/09/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The availability of drinking water on postural sway following a simulated military march in the heat
Scientific title
The effect of hydration on postural sway following a simulated military march in the heat in trained military personnel and healthy trained members of the community
Secondary ID [1] 312932 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human fatigue in the heat 335096 0
Condition category
Condition code
Other 331598 331598 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine the effect of heat stress and dehydration from a self-paced 60 min march in the heat. Descriptive characteristics of the participants will be measured (height, mass, body composition by DEXA). Peak power output and oxygen consumption will be determined on a treadmill using a standard ramped protocol and standard metabolic cart methods available in our laboratory. Participants will be initially randomly assigned to a dehydration (control - DEH) or hydration (intervention - HYD) group. The experiment will be conducted in climate chamber with temperature set at ~30 +/-2°C, relative humidity set at 50 +/-2%. Participants will undertake two trials (DEH & HYD) wearing standard military combat gear. The goal of the march will be to complete a 60 min march. Participants in the HYD trial will consume plain water ad libitum. The time between the cross over for trials for each participant will be a minimum of 3 days and no more that 7 days.

Measurements: The following measurements will be taken for the purpose of further understanding the key responses during heat stress with and without hydration. A finger prick blood sample will be collected before, each 20 min interval and at the completion of the test to assess blood lactate, glucose, haemoglobin and hematocrit. To assess the level of hydration, a urine sample will be collected before and at the completion of the test which will be checked for osmolality.

Core temperature will be continuously monitored and recorded at 5 min intervals via radio telemetry pill ingested 5 h before the trial. Skin temperature at four sites will be monitored continuously and recorded at similar intervals with the use of iButtons. Heart rate will also be continuously monitored and recorded at 15 s intervals. Rating of perceived exertion (RPE), thermal comfort, thermal sensation and thirst sensation will be measured and recorded a 10 min intervals.

To further understand and evaluate the effect of dehydration during long marches in the heat, urinary samples will be taken prior to and immediately on completion of the trial and will be analysed for osmolality (Advanced Micro Osmometer 3300, Advanced Instruments Inc, MA, USA). This will allow the evaluation of hydration and its potential effects on body fluid compartments.

To examine the potential combined effect of hydration, heat stress and a long march on postural stability and sway, participants will immediately undertake a NeuroCom test each 10 min. Using a NeroCom Balance (VSR SPORT; NeuroCom International, Clackamas, OR, USA), each participant’s static control will be assessed by performing a stability evaluation test and limits of stability test. A stability evaluation test will be used to assess an individual’s postural sway velocity during double-tandem. Limits of stability will assess the ability of the participant to move their centre of gravity location accurately and quickly voluntarily to predetermined targets without losing balance. The postural sway that might eventuate will be no more than what is experienced following normal exercise. It is not detectable by the participant. The apparatus that they will stand on will not cause sway. It will measure the amount of force that changes from one foot to the other over the 20 s measurement period.

Immediately following each postural sway measurement, the participant will be handed a simulation laser guided pistol and requested to aim the laser at predetermined targets on the wall in front of them. They will randomly fire at the targets which will measure their accuracy at various stages of the exercise trial. The simulated pistol is produced and identified as a plastic toy, and operates similar to common toy pistols used for playing video games. Consequently, licensing and permits are not required. Operating the simulated pistol is akin to playing a video game, no prior experience with a firearm is necessary. Nevertheless, participants will be instructed on how to use the simulated pistol before any data collection. This will include instructions to only point the simulated pistol at the targets, and never at a person, including themselves or the researchers. No protective eyewear is required, as the simulated pistol is produced as a toy and emits a very low-intensity light that is safe for the naked eye.
Intervention code [1] 329464 0
Treatment: Other
Comparator / control treatment
Participants will be initially randomly assigned to a dehydration (control - DEH) or hydration (treatment - HYD) group for the purpose of comparing the effect of drinking ad libitum versus restricted fluid during exercise in the heat on fatigue, postural sway and aiming capability.

The control - DEH group wiil be restricted to consuming no water during the trial.
Control group
Active

Outcomes
Primary outcome [1] 339335 0
Postural changes with and without fluid availability and drinking
Timepoint [1] 339335 0
pre trial, 20 min, 40 min, immediately post trial
Secondary outcome [1] 439559 0
Changes in core and skin temperature with and without hydration will be assessed as a composite outcome at pre trial, 20 min, 40 min, immediately post trial
Timepoint [1] 439559 0
Each 15 seconds data will be captured but visually displayed to researchers for real time assessment
Secondary outcome [2] 439560 0
Accuracy of simulated pistol laser shooting at pre trial, 20 min, 40 min, immediately post trial.
Timepoint [2] 439560 0
Pre trial, 20 min, 40 min, immediately post trial
Secondary outcome [3] 439772 0
Blood analysis for Haemoglobin and hematocrit which will be combined to assess changes in blood and plasma volume from start to finish of the trial.
Timepoint [3] 439772 0
immediately pre and post trial.
Secondary outcome [4] 439773 0
Urine osmolality will be assessed with the participant providing a sample prior to the trial and then a sample immediately post trial.
Timepoint [4] 439773 0
Samples will be taken at pre and post trial.
Secondary outcome [5] 439774 0
Blood lactate will be measured to assess the intensity of the exercise.
Timepoint [5] 439774 0
samples assessed pre, 20, 40 min and post trial.
Secondary outcome [6] 439775 0
Blood glucose will be measured to assess metabolic status.
Timepoint [6] 439775 0
smples assessed at pre, 20, 40 min and post trial
Secondary outcome [7] 440051 0
Hematocrit will be assessed by finger prick capillary blood sample at pre trial, and immediately post trial
Timepoint [7] 440051 0
pre trial, and immediately post trial.
Secondary outcome [8] 440052 0
Heart rate will be monitored continuously via a garmin monitor
Timepoint [8] 440052 0
At rest, each 5 min interval and immediately end of trial
Secondary outcome [9] 440053 0
Rating of perceived exertion (RPE) using the Borg 6-20 scale will be assessed at start and each 5 min and immediately at the end of the trial.
Timepoint [9] 440053 0
at start and each 5 min and at end of trial.
Secondary outcome [10] 440054 0
Thermal comfort/sensation, used interchangeably will be assessed using a scale ranging from 1-7 (1 cool - 7 unbearably hot).
Timepoint [10] 440054 0
Assessed at start of trial, each 5 min and at end of trial.

Eligibility
Key inclusion criteria
The aim is to recruit both trained military personnel and healthy trained members of the community aged 18-45 years for the purpose of comparison of distinct groups. The sample size will be up to 18 participants from each group. Our contacts through the Spitfire Association (funding body) and through the ADF will assist in recruiting of appropriate trained personnel. Recruitment of community participants will be undertaken by the researchers and assistants. In all recruitment, participation will be voluntary. The participants must have a level of physical training developed with at least 3 days per week of sufficient aerobic exercise lasting 30-40 min in duration per day for at least 3 months prior to study commencement.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Injuries to any joint, co-morbidities type 2 diabetes mellitus, hypertension,VO2mx below 30 ml.kg.min as assessed by a ramped exercise protocol. Pre-screening questionnaire as provided by Exercise & Sports Science Australia will be used to determine suitability.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation determined by coin toss moments prior to trial commencement
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The data will be analysed by repeated measures ANOVA with the source of significant differences located using appropriate simple main effects and multiple comparison tests. Effect sizes will also be used where appropriate and correction factors employed when data are not evenly distributed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
15/10/2024
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
18
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 43157 0
2795 - Bathurst
Recruitment postcode(s) [2] 43158 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 317363 0
Charities/Societies/Foundations
Name [1] 317363 0
Spitfire Association
Country [1] 317363 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 319652 0
None
Name [1] 319652 0
Address [1] 319652 0
Country [1] 319652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316095 0
Charles Sturt University Human Research Ethics Committee
Ethics committee address [1] 316095 0
Ethics committee country [1] 316095 0
Australia
Date submitted for ethics approval [1] 316095 0
03/04/2023
Approval date [1] 316095 0
31/05/2023
Ethics approval number [1] 316095 0
H23552

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

Contacts
Principal investigator
Name 136762 0
Prof Francesco Marino
Address 136762 0
Building 1008, School of Rural Medicine, Charles Sturt University, Leeds Parade, Orange NSW 2800
Country 136762 0
Australia
Phone 136762 0
+61 02 63384268
Fax 136762 0
Email 136762 0
[email protected]
Contact person for public queries
Name 136763 0
Francesco Marino
Address 136763 0
Building 1008, School of Rural Medicine, Charles Sturt University, Leeds Parade, Orange NSW 2800
Country 136763 0
Australia
Phone 136763 0
+61 02 63384268
Fax 136763 0
Email 136763 0
[email protected]
Contact person for scientific queries
Name 136764 0
Francesco Marino
Address 136764 0
Building 1008, School of Rural Medicine, Charles Sturt University, Leeds Parade, Orange NSW 2800
Country 136764 0
Australia
Phone 136764 0
+61 02 63384268
Fax 136764 0
Email 136764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual privacy with respect to health status.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24181Ethical approval    388426-(Uploaded-17-09-2024-21-16-19)-Ethics Spitfire Approval.pdf



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.