Trial Review

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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
Date results information 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] 303064 0
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 320130 0
Generation of droplets during exercise 320131 0
Condition category
Condition code
Public Health 318073 318073 0 0
Other public health
Respiratory 318475 318475 0 0
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] 319407 0
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] 326118 0
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] 326118 0
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] 326436 0
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] 326436 0
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] 326437 0
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] 326437 0
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] 390192 0
Droplet and aerosol generation will be compared at 30cm, 1.5m, 3metres to the participant.
Timepoint [1] 390192 0
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] 391483 0
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] 391483 0
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
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18327 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 32405 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307472 0
Other
Name [1] 307472 0
Baker Heart and Diabetes Institute
Country [1] 307472 0
Australia
Funding source category [2] 307776 0
Hospital
Name [2] 307776 0
St Vincents Hospital
Country [2] 307776 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
75 Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 308143 0
None
Name [1] 308143 0
Address [1] 308143 0
Country [1] 308143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307548 0
Alfred Health Ethics Commitee
Ethics committee address [1] 307548 0
55 Commercial Road
Melbourne
VIC 3004
Ethics committee country [1] 307548 0
Australia
Date submitted for ethics approval [1] 307548 0
26/10/2020
Approval date [1] 307548 0
18/11/2020
Ethics approval number [1] 307548 0
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 107630 0
A/Prof Andre La Gerche
Address 107630 0
Department of Sports Cardiology
75 Commercial Road
Melbourne
VIC 3004
Country 107630 0
Australia
Phone 107630 0
+61 3 8532 1143
Fax 107630 0
Email 107630 0
[email protected]
Contact person for public queries
Name 107631 0
Dr Brian Cowie
Address 107631 0
Department of Anaesthesia
St. Vincent's Hospital
44 Victoria Parade
Fitzroy 3065
Country 107631 0
Australia
Phone 107631 0
+61 3 92882211
Fax 107631 0
Email 107631 0
[email protected]
Contact person for scientific queries
Name 107632 0
Dr Brian Cowie
Address 107632 0
Department of Anaesthesia
St. Vincent's Hospital
44 Victoria Parade
Fitzroy 3065
Country 107632 0
Australia
Phone 107632 0
+61 3 92882211
Fax 107632 0
Email 107632 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
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.TypeCitationLinkEmailOther DetailsAttachment
10169Study protocol  [email protected]
10170Statistical analysis plan  [email protected]
10171Informed consent form  [email protected]
10172Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAerosol Generation During High Intensity Exercise-Implications for COVID-19 Transmission.2023https://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.