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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]

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

peripheral arterial disease prevention

environmental toxin metabolism

wellness

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Cardiovascular

Normal development and function of the cardiovascular system

Metabolic and Endocrine

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]

Treatment: Other

Intervention code [2]

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]

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]

10 minutes before intervention,
During intervention - approximately 35 minutes [primary timepoint]
10 minutes after intervention

Primary outcome [2]

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]

10 minutes before intervention,
During intervention - approximately 35 minutes (primary timepoint)
10 minutes after intervention

Primary outcome [3]

Exploratory laboratory metabolomic/toxicant analysis of collected sweat samples

Timepoint [3]

Pooled collection of sweat during 35-minute intervention

Secondary outcome [1]

Skin temperature reading using an infrared 'no touch' thermometer

Timepoint [1]

10 minutes before intervention
During intervention (during 5-min break after 15 min of intervention)
10 minutes after intervention

Secondary outcome [2]

O2 saturation readings using a finger pulsoximeter device.

Timepoint [2]

10 minutes before intervention,
During intervention,
10 minutes after intervention

Secondary outcome [3]

“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]

During intervention

Secondary outcome [4]

Exploratory laboratory metabolomic/toxicant analysis of participant-collected urine samples

Timepoint [4]

10 minutes before intervention,
10 minutes after intervention

Secondary outcome [5]

core body temperature reading using a standard medical digital ear thermometer

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4005 - New Farm

Recruitment postcode(s) [2]

4000 - Brisbane

Recruitment postcode(s) [3]

4520 - Samford Valley

Recruitment postcode(s) [4]

4051 - Grange

Recruitment postcode(s) [5]

4066 - Mount Coot-Tha

Recruitment postcode(s) [6]

4066 - Toowong

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

RMIT University,
School of Health and Biomedical Sciences
Bundoora Campus West, Bldg 215, Level 3
Plenty Rd
Bundoora VIC 3083

Country [1]

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]

University

Name [1]

University of Queensland/ Queensland Alliance for Environmental Health Sciences

Address [1]

Queensland Alliance for Environmental Health Sciences
39 Kessels Road
Coopers Plains, QLD 4108

Country [1]

Australia

Other collaborator category [1]

Government body

Name [1]

Queensland Academy of Sport

Address [1]

Level 1, Queensland Sport and Athletics Centre (QSAC)
468 Kessels Road
Nathan Qld 4111

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT Human Research Ethics Committee

Ethics committee address [1]

RMIT - Human Research Ethics Committee
Building 91, Level 2, City Campus
Melbourne  VIC  3000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/12/2017

Approval date [1]

20/08/2018

Ethics approval number [1]

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

A/Prof Ronda Greaves

Address

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

Australia

Phone

+61 (03) 8341 6347

Fax

[email protected]

Contact person for public queries

Name

Joy Hussain

Address

RMIT University,
School of Health and Biomedical Sciences
Bundoora Campus West, Bldg 215, Level 3
Plenty Rd
Bundoora VIC 3083

Country

Australia

Phone

+61 439383889

Fax

[email protected]

Contact person for scientific queries

Name

Ronda Greaves

Address

Country

Australia

Phone

+61 (03) 8341 6347

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
247	Study protocol	374922-(Uploaded-14-11-2018-15-07-22)-Study-related document.docx
248	Informed consent form	374922-(Uploaded-14-11-2018-15-10-17)-Study-related document.docx
249	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Infrared sauna as exercise-mimetic? Physiological responses to infrared sauna vs exercise in healthy women: A randomized controlled crossover trial.	2022	https://dx.doi.org/10.1016/j.ctim.2021.102798

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically