Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000398404
Ethics application status
Approved
Date submitted
10/02/2025
Date registered
2/05/2025
Date last updated
30/06/2025
Date data sharing statement initially provided
2/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Comparing Blood Flow Restriction Devices: How They Measure Limb Pressure"
Scientific title
Comparison of different blood flow restriction devices in assessing the limb occlusion pressure in healthy active athletes
Secondary ID [1] 313619 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
blood flow restriction 336170 0
Condition category
Condition code
Cardiovascular 332715 332715 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our objective is to compare limb occlusion pressure (LoP) measurements obtained using different devices in recreationally active individuals. This study employs a crossover design, with 21 participants undergoing LoP assessments in both supine and standing positions using each of the following five devices:

ZIMMER Tourniquet System – a medical-grade pneumatic device commonly used in surgical and clinical settings for controlled occlusion.

SUJI BFR Cuff – a semi-automated blood flow restriction system that connects to a smartphone app for guided occlusion pressure application.

AIRBANDs – manually inflated cuffs with a handheld pump and integrated pressure gauge, typically used in fitness environments.

SMART Cuffs Pro – an automated BFR system that determines LoP via pulse detection technology.

Pulse oximeter paired with a standard blood pressure cuff – a traditional method used to estimate LoP based on the disappearance of pulse signal, serving as a reference technique.

Participant anthropometrics including height, weight, and leg dominance will be recorded prior to testing. All device applications will be performed by a certified exercise physiologist to ensure consistency and safety.

For each device, participants will undergo two trials: one trial to determine LoP in the supine position and one trial to determine LoP in the standing position. No exercise protocols will be performed during these trials; the trials will only involve inflation of the cuff to determine LoP. The time to determine LoP will vary between devices, typically ranging from 20 seconds to 2 minutes.

Devices will be applied in a randomized order, and two trials will be conducted per device on the dominant leg, with a 5-minute rest (washout) period between trials to allow for full vascular recovery and eliminate carryover effects. A brief familiarization session with each device will be provided before formal testing.

After each LoP trial, participants will rate their perceived discomfort using a standard 0–10 numerical scale.

All testing will be conducted in a single session lasting approximately 120 to 150 minutes per participant. This crossover protocol, incorporating randomization and washout periods, is designed to ensure the internal validity of comparisons across devices.
Intervention code [1] 330527 0
Treatment: Other
Intervention code [2] 330929 0
Rehabilitation
Comparator / control treatment
Pulse oximeter paired with a standard blood pressure cuff
Control group
Active

Outcomes
Primary outcome [1] 340688 0
LoP measurement using all 5 equipment's supine– This is the pressure required to to occlude the blood supply in the lower limb.
Timepoint [1] 340688 0
Each equipment will be used to assess Limb Occlusion Pressure (LoP) twice in the supine position—at baseline and again 5 minutes later, prior to standing.
Primary outcome [2] 341262 0
LoP measurement using all 5 equipment's standing– This is the pressure required to to occlude the blood supply in the lower limb.
Timepoint [2] 341262 0
Each equipment will also be used to assess LoP while the participant is standing at 11 minutes and 16 minutes post-commencement of occlusion.
Secondary outcome [1] 444799 0
Ratings of discomfort – Is a subjective method used to measure an individual's perception of how difficult they are perceiving during pressure inflation.
Timepoint [1] 444799 0
After each equipment scale will be asked for participants to respond.

Eligibility
Key inclusion criteria
aged 18-40 years,
recreationally active with an IPAQ score above 600 METs per week equivalent to 150-300 minutes of physical exercise involvement,
no known medical conditions, and
no injuries in the last six months
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any known medical condition and any injuries in the last six months.
resting blood pressure greater than 150/100 mmHg

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/08/2024
Date of last participant enrolment
Anticipated
Actual
30/08/2024
Date of last data collection
Anticipated
Actual
30/08/2024
Sample size
Target
21
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318087 0
University
Name [1] 318087 0
Deakin University
Country [1] 318087 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 320826 0
None
Name [1] 320826 0
Address [1] 320826 0
Country [1] 320826 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316735 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 316735 0
Ethics committee country [1] 316735 0
Australia
Date submitted for ethics approval [1] 316735 0
10/05/2024
Approval date [1] 316735 0
25/06/2024
Ethics approval number [1] 316735 0

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

Contacts
Principal investigator
Name 138838 0
A/Prof Stuart Warmington
Address 138838 0
School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 138838 0
Australia
Phone 138838 0
+61 3 925 17013
Fax 138838 0
Email 138838 0
[email protected]
Contact person for public queries
Name 138839 0
Stuart Warmington
Address 138839 0
School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 138839 0
Australia
Phone 138839 0
+61 3 925 17013
Fax 138839 0
Email 138839 0
[email protected]
Contact person for scientific queries
Name 138840 0
Stuart Warmington
Address 138840 0
School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country 138840 0
Australia
Phone 138840 0
+61 3 925 17013
Fax 138840 0
Email 138840 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    HEAG-H 105_2024-240625-Approval memo.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.