ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000130864

Ethics application status

Approved

Date submitted

12/01/2021

Date registered

8/02/2021

Date last updated

8/02/2021

Date data sharing statement initially provided

8/02/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Droplet and aerosol generation during high intensity exercise

Scientific title

Droplet and aerosol generation during high intensity exercise

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Respiratory infection risk during exercise

Generation of droplets during exercise

Condition category

Condition code

Public Health

Other public health

Respiratory

Normal development and function of the respiratory system

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Characterization of the size, number, volume, dispersion and clearance of droplet/aerosol particles during high intensity exercise.
The COVID-19 pandemic is ongoing and there is little data on the spread of droplets and aerosols during moderate to high intensity exercise. Data on aerosolisation in exercise may assist in guiding rational use of face masks and allowing appropriate distancing in participant’s gymnasium’s as communities look to re-open in the COVID-19 era.
The data will also guide appropriate safety precautions to staff involved in cardiopulmonary exercise testing and exercise echocardiography, where currently no evidence exists on droplet and aerosol generation.
Study participants will undergo a maximal cardiopulmonary exercise test and a spirometry test using a Vyntus CPX metabolic chart and a lode bicycle ergometer. The exercise intensity (workload) at which the participants will exercise for multiple 5minutes bouts for the measurements of droplets and aerosols will be determined from this test. The participants will exercise for 5minutes at the determined workload using the Vyntus CPX metabolic chart to determine minute ventilation, flow and volume.
Baseline measurements of droplet/aerosol particles will occur in the clean exercise room before commencement of the experiment. This clean room is an operating room with high efficiency particulate air (HEPA) filtered air. Droplet and aerosol particles will be detected using an Aerodynamic Particle Sizer (APS) and a Mini Wide Range Aerosol Spectrometer (MiniWRAS) that will be operated by experts in droplet/aerosol detection and behaviour.
Participants will be asked to exercise for 5minutes at high intensity with no mask, a standard surgical mask and a N95 mask. Repeat droplet/aerosol measurements will occur during each stage after clearance of droplets/aerosols and return to baseline.
All investigators will wear N95 masks to minimise droplet/aerosol contamination from subjects other than participants.
Detection of droplet/aerosols will occur from sampling sites at increasing distance from the participants, 30cm, 1.5m and 3m, frontal, lateral and posterior. These distances will be measured and marked by tape on the floor prior to testing.
The cardiopulmonary exercise test (CPET) will be conducted by a research nurse and exercise physiologist. The 5minute exercise sessions for the different measurements in the operating room will be supervised by a team of investigators including an anesthetist, research nurse, exercise physiologist and research scientists who will operate the APS and MiniWRAS.
The participants will be asked to come in over three separate visits. The first visit will include the CPET and the 5minute exercise test at the determined workload. This visit will take around 1hour 30minutes of their time. The measurements in the operating room will take place over two full days with 8 exercise sessions, each taking 5minutes, per participant on each day. A total of 16, 5 minute exercise sessions per participant over the 2 days. Each separate measurement mask/no mask at different distances will take 5 minutes. Sufficient time will be given in between sessions to allow for the droplet/aerosol count to return back to baseline.

Intervention code [1]

Not applicable

Comparator / control treatment

Droplet/aerosol generation during exercise will be compared between wearing no mask and wearing a surgical mask.

Control group

Active

Outcomes

Primary outcome [1]

Characterization of the size of droplet/aerosol particles during high intensity exercise in a HEPA filtered room using an Aerodynamic Particle Sizer (APS) and a Mini Wide Range Aerosol Spectrometer (MiniWRAS).

Timepoint [1]

Each assessment will be conducted under separate conditions, When the participant is wearing no mask, participant is wearing a surgical mask and participant is wearing an N95 mask, at 30cm, 1.5m and 3m and measuring frontal, lateral and posterior to the participant.

Primary outcome [2]

Characterization of the volume of droplet/aerosol particles during high intensity exercise in a HEPA filtered room using an Aerodynamic Particle Sizer (APS) and a Mini Wide Range Aerosol Spectrometer (MiniWRAS)

Timepoint [2]

Each assessment will be conducted under separate conditions, When participant is wearing no mask, participant is wearing a surgical mask and participant is wearing an N95 mask, at 30cm, 1.5m and 3m and measuring frontal, lateral and posterior to the participant.

Primary outcome [3]

Characterization of the dispertion of droplet/aerosol particles during high intensity exercise in a HEPA filtered room using an Aerodynamic Particle Sizer (APS) and a Mini Wide Range Aerosol Spectrometer (MiniWRAS).

Timepoint [3]

Each assessment will be conducted under separate conditions, When the participant is wearing no mask and the participant is wearing a surgical mas at 30cm, 1.5m and 3m and measuring frontal, lateral and posterior to the participant.

Secondary outcome [1]

Droplet and aerosol generation will be compared at 30cm, 1.5m, 3metres to the participant.

Timepoint [1]

Each assessment will be conducted under separate conditions, When the participant is wearing no mask, participant is wearing a surgical mask and participant is wearing an N95 mask, measuring frontal, lateral and posterior to the participant.

Secondary outcome [2]

Droplet and aerosol generation will be compared when the participant is wearing no mask, participant is wearing a surgical mask and participant is wearing a N95 mask.

Timepoint [2]

Each assessment will be conducted under separate conditions, At 30cm, 1.5m and 3m and measuring frontal, lateral and posterior to the participant.

Eligibility

Key inclusion criteria

The participant must be over 18years of age, be free of any significant underlying medical condition, be eligible for medicare, be able to perform high intensity exercise for up to 2 hours.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

A person will be excluded from this study if they have a condition or disease where exercise is contraindicated and/or if they are unable to speak or understand English.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

This is a hypothesis generating pilot study to estimate the number, volume, dispersion and clearance of droplet/aerosol particles during moderate intensity exercise.
There is currently little to no data on the impact of droplet/aerosol generation during moderate intensity exercise in an indoor environment. This includes cardiopulmonary exercise labs in healthcare facilities and public gymnasiums. We are unaware of any similar published data. so the number of participants required to achieve the study objectives is unclear. A pilot observational study looking at droplet/aerosol generation in tracheal intubation generated useful data with 3 participants.
Descriptive statistics will be used to describe mean and standard deviation of droplet and aerosol count between the 3 participants from .0.1 to 20 microns in size.. Independent t-test samples will be used to assess for differences between distances of 30/150/300cm from the participants, with and without a surgical face mask. A P value of p < 0.05 will be defined as significant. Analyses will be performed using open source statistical software.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

11/12/2020

Date of last participant enrolment

Anticipated

Actual

11/12/2020

Date of last data collection

Anticipated

Actual

18/12/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Baker Heart and Diabetes Institute - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Baker Heart and Diabetes Institute

Address [1]

75 Commercial Road
Melbourne
VIC 3004
Aistralia

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

St Vincents Hospital

Address [2]

41 Victoria Parade
Fitzroy
VIC 3065

Country [2]

Australia

Primary sponsor type

Other

Name

Baker Heart and Diabetes Institute

Address

75 Commercial Road
Melbourne
VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Ethics Commitee

Ethics committee address [1]

55 Commercial Road
Melbourne 
VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/10/2020

Approval date [1]

18/11/2020

Ethics approval number [1]

709/20

Summary

Brief summary

This study will seek to evaluate the generation of droplets and aerosol during high intensity exercise. We will characterise the droplet and aerosol size, volume and direction in an indoor environment during high intensity exercise in athletes. These measurements will be done with the participants wearing no mask or a surgical mask and sampling will happen at different distances and locations. We will compare the concentration of droplets/aerosol at 3 different distances of .3, 1.5 and 3 metres from the participant with and without a surgical mask.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andre La Gerche

Address

Department of Sports Cardiology
75 Commercial Road
Melbourne
VIC 3004

Country

Australia

Phone

+61 3 8532 1143

Fax

[email protected]

Contact person for public queries

Name

Brian Cowie

Address

Department of Anaesthesia
St. Vincent's Hospital
44 Victoria Parade
Fitzroy 3065

Country

Australia

Phone

+61 3 92882211

Fax

[email protected]

Contact person for scientific queries

Name

Brian Cowie

Address

Department of Anaesthesia
St. Vincent's Hospital
44 Victoria Parade
Fitzroy 3065

Country

Australia

Phone

+61 3 92882211

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

Summary data will be published in a peer reviewed journal.
Raw data from this experiment is highly complex with the APS device sampling every second.
Including the baseline overnight measures for >12 hours, there will be something in the order of >50000 data points. In addition to these multiple time points, the APS and miniWRAS devices have multiple sampling channels detecting the droplet/aerosol counts of particles from 0.1->20 microns in size. Each aerosol/droplet detector analyses the atmosphere and uses proprietary protected software to manage the huge volumes of data.

What supporting documents are/will be available?

Doc. No.	Type	Email
10169	Study protocol	[email protected]
10170	Statistical analysis plan	[email protected]
10171	Informed consent form	[email protected]
10172	Ethical approval	[email protected]

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	Aerosol Generation During High Intensity Exercise-Implications for COVID-19 Transmission.	2023	https://dx.doi.org/10.1016/j.hlc.2022.10.014

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

Trial Review

Documents added manually

Documents added automatically