Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000679280
Ethics application status
Approved
Date submitted
20/04/2018
Date registered
26/04/2018
Date last updated
19/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring physiological and metabolomic changes with sauna and exercise in healthy young volunteers
Scientific title
Exploring physiological and metabolomic changes with sauna and exercise in healthy young volunteers
Secondary ID [1] 294624 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Sauna-Exercise Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease prevention 307458 0
peripheral arterial disease prevention 307459 0
environmental toxin metabolism 307460 0
wellness 307461 0
Condition category
Condition code
Alternative and Complementary Medicine 306542 306542 0 0
Other alternative and complementary medicine
Cardiovascular 306543 306543 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 306544 306544 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive three interventions (after a control intervention) on separate occasions in a randomised crossover sequence with a minimum of 48 hours washout.

Intervention I- Exercise
45 minutes total [2 x 15-minute sessions separated by 10-15-min cool-down (at controlled room temperature, ~25oC)] of monitored exercise on cycle ergometer equivalent to moderate intensity (based upon maximal heart rate calculations);

Intervention II- Infrared Sauna Cabin
45 minutes total [2 x 15-minute sessions separated by 10-15 min cool-down (at room temperature, ~25oC)] of monitored full spectrum infrared sauna activity at 60oC, < 10-20% relative humidity;

Intervention III- Finnish-style Sauna
45 minutes total [2 x 15-min sessions separated by 10-15 min cool-down at room temperature, ~25oC) of monitored Finnish-style sauna activity at ~80oC, < 10-20% relative humidity, allowing brief periods of cool water to be thrown on sauna heater rocks if individually chosen and tolerated during the sauna activity.


Each intervention will be monitored closely by a registered medical practitioner of > 20+ years clinical experience and conducted at a Brisbane-based athletic facility.
Intervention code [1] 300926 0
Treatment: Other
Intervention code [2] 300927 0
Lifestyle
Comparator / control treatment
Control intervention added to protocol at step before crossover sequence of three interventions stated (exercise, infrared sauna, traditional sauna). The control intervention will involve same sequence of steps as other intervention, except no exercise or hyperthermia will be applied; instead participants will be instructed to rest quietly for the 45 minute intervention time.
Control group
Active

Outcomes
Primary outcome [1] 305612 0
Continuous heart rate variability will be measured using The SphygmoCor device (AtCor Medical, Sydney, Australia) which measures and analyses the standard deviations of normal R-R intervals on continuous 3-lead electrocardiogram monitoring.
Timepoint [1] 305612 0
10 minutes before intervention,
During intervention - approximately 35 minutes [primary timepoint]
10 minutes after intervention
Primary outcome [2] 305613 0
Pulse wave velocity testing will be obtained using the SphygmoCor XCEL System (AtCor Medical, Sydney, Australia), which measures the pulse wave velocity of the arterial pulse waveform travelling through the descending aorta to the femoral artery. The aortic wave velocity is detected from carotid and femoral arterial pulses measured non-invasively and simultaneously. The carotid pulse is measured using the tonometer while the femoral pulse is measured through pulsations in a cuff placed around the upper thigh.
Timepoint [2] 305613 0
10 minutes before intervention,
During intervention - approximately 35 minutes (primary timepoint)
10 minutes after intervention
Primary outcome [3] 305614 0
Exploratory laboratory metabolomic/toxicant analysis of collected sweat samples
Timepoint [3] 305614 0
Pooled collection of sweat during 35-minute intervention
Secondary outcome [1] 345897 0
Skin temperature reading using an infrared 'no touch' thermometer
Timepoint [1] 345897 0
10 minutes before intervention
During intervention (during 5-min break after 15 min of intervention)
10 minutes after intervention
Secondary outcome [2] 345898 0
O2 saturation readings using a finger pulsoximeter device.
Timepoint [2] 345898 0
10 minutes before intervention,
During intervention,
10 minutes after intervention
Secondary outcome [3] 345899 0
“Time to sweat” , defined as time elapsed during each intervention until first beads of sweating are experienced by participant and confirmed observationally by clinician
Timepoint [3] 345899 0
During intervention
Secondary outcome [4] 345901 0
Exploratory laboratory metabolomic/toxicant analysis of participant-collected urine samples
Timepoint [4] 345901 0
10 minutes before intervention,
10 minutes after intervention
Secondary outcome [5] 346035 0
core body temperature reading using a standard medical digital ear thermometer
Timepoint [5] 346035 0
10 minutes before intervention
during intervention (during 5-min break after 15 min of intervention)
10 minutes after intervention

Eligibility
Key inclusion criteria
All participants will be
-aged between 18-40 years
-non-smokers
-English speaking and able to give written informed consent
-willing and able to engage in sauna activities (both far-infrared and Finnish-style)
-willing and able to engage in 30 minutes of moderate-intensity exercise (stationary bicycle)
-willing to avoid over the counter medicines such as Nurofen and Paracetamol for 24 hours prior to the study sessions.
-willing to avoid topical perfume and skin preparations for 24 hours prior to the study sessions
-willing to fast overnight (minimum 12 hours)
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are:
- smokers
- diagnosed with diabetes or chronic medical condition (i.e. current or previous history of renal, cardiac, gastrointestinal, liver, skin, psychiatric disorders or respiratory -other than asthma not requiring continuous medication) or any other condition for which the subject is currently taking medications or in the opinion of the investigators would impede competence, compliance, or participation in the study.
-recent hospitalisation, surgery or antibiotic therapy
-taking any medications or supplements on a regular basis; regular consumption of prescription or OTC (over the counter) medications such as proton pump inhibitors, non-steroidal anti-inflammatory drugs, or pain medications
-clinically underweight (BMI < 18.5 kg/m2) or obese (BMI > 30 kg/m2);
-orthopaedic or cardiovascular limitations that precludes participation in sauna or moderate exercise;
-regular performance of > 60 minutes daily, 7 days/week of continuous physical activity defined as “vigorous” by Sports Medicine Australia (i.e. training for triathlon, marathon)
-any participation in regular heat-acclimation (i.e. hot yoga) or exercise-acclimation activities (i.e. hyperbaric chamber) within the past 6 months.
-have been regularly sauna bathing during the past 6 months
-pregnant or expect/attempting to become pregnant or impregnate
-currently having irregular menstrual periods
-unable to give informed consent

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)
Participants will be randomised to the order of 3 interventions given in this crossover study but allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation will be used to determine the order of three interventions delivered to each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Single-blinded, single group crossover study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Microsoft Excel and the Statistical Package for the Social Sciences (SPSS) software program will be utilised for statistical analysis of results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
Date of last participant enrolment
Anticipated
1/09/2019
Actual
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 22503 0
4005 - New Farm
Recruitment postcode(s) [2] 22504 0
4000 - Brisbane
Recruitment postcode(s) [3] 22505 0
4520 - Samford Valley
Recruitment postcode(s) [4] 22506 0
4051 - Grange
Recruitment postcode(s) [5] 22507 0
4066 - Mount Coot-Tha
Recruitment postcode(s) [6] 22508 0
4066 - Toowong

Funding & Sponsors
Funding source category [1] 299240 0
University
Name [1] 299240 0
RMIT University
Country [1] 299240 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
RMIT University,
School of Health and Biomedical Sciences
Bundoora Campus West, Bldg 215, Level 3
Plenty Rd
Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 298514 0
University
Name [1] 298514 0
University of Queensland/ Queensland Alliance for Environmental Health Sciences
Address [1] 298514 0
Queensland Alliance for Environmental Health Sciences
39 Kessels Road
Coopers Plains, QLD 4108
Country [1] 298514 0
Australia
Other collaborator category [1] 280434 0
Government body
Name [1] 280434 0
Queensland Academy of Sport
Address [1] 280434 0
Level 1, Queensland Sport and Athletics Centre (QSAC)
468 Kessels Road
Nathan Qld 4111
Country [1] 280434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300163 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 300163 0
RMIT - Human Research Ethics Committee
Building 91, Level 2, City Campus
Melbourne VIC 3000
Ethics committee country [1] 300163 0
Australia
Date submitted for ethics approval [1] 300163 0
12/12/2017
Approval date [1] 300163 0
20/08/2018
Ethics approval number [1] 300163 0
RMIT HREC - Project no. 21191

Summary
Brief summary
The purpose of this research study is to investigate the changes in cardiovascular function and contents of sweat and urine in healthy young adults after a single session of Finnish-style sauna, far infrared sauna and exercise in comparison to a control resting activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82746 0
A/Prof Ronda Greaves
Address 82746 0
RMIT University, School of Health and Biomedical Sciences Bundoora Campus West, Bldg 201, Level 9, Plenty Rd, Bundoora VIC 3083
and
Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Flemington Rd, Parkville VIC 3052
Country 82746 0
Australia
Phone 82746 0
+61 (03) 8341 6347
Fax 82746 0
Email 82746 0
[email protected]
Contact person for public queries
Name 82747 0
Dr Joy Hussain
Address 82747 0
RMIT University,
School of Health and Biomedical Sciences
Bundoora Campus West, Bldg 215, Level 3
Plenty Rd
Bundoora VIC 3083
Country 82747 0
Australia
Phone 82747 0
+61 439383889
Fax 82747 0
Email 82747 0
[email protected]
Contact person for scientific queries
Name 82748 0
A/Prof Ronda Greaves
Address 82748 0
RMIT University, School of Health and Biomedical Sciences Bundoora Campus West, Bldg 201, Level 9, Plenty Rd, Bundoora VIC 3083
and
Victorian Clinical Genetics Services, Murdoch Children's Research Institute, Flemington Rd, Parkville VIC 3052
Country 82748 0
Australia
Phone 82748 0
+61 (03) 8341 6347
Fax 82748 0
Email 82748 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 metabolomics data is exploratory and not meant to be quantitative for an individual. Final group data in the form of the publication output will be provided.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
247Study protocol    374922-(Uploaded-14-11-2018-15-07-22)-Study-related document.docx
248Informed consent form    374922-(Uploaded-14-11-2018-15-10-17)-Study-related document.docx
249Ethical approval    374922-(Uploaded-14-11-2018-15-12-17)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfrared sauna as exercise-mimetic? Physiological responses to infrared sauna vs exercise in healthy women: A randomized controlled crossover trial.2022https://dx.doi.org/10.1016/j.ctim.2021.102798
N.B. These documents automatically identified may not have been verified by the study sponsor.