Blood Flow Restriction (BFR) Training EffectsNCT06718582
Effect of Limb Occlusion Pressure Attainment on Cardiovascular, Perceptual, and Performance Responses
A study testing Delfi Training Device in people with Blood Flow Restriction (BFR) Training Effects and Arterial Stiffness, Blood Pressure, run by Teri Herberger at 1 site in United States.
Trial summary
To test the effect of limb occlusion pressure attainment in the supine, seated, and standing position on exercise performance, vascular physiology, and muscle. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction (BFR) Training Effects, Arterial Stiffness, Blood Pressure, Muscle Morphology
- What is being tested?
- Delfi Training Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (> 1,000 MET/min/wk) for at least six months. Weight stable for previous 6 months (+/-2.5 kg) Female subjects only- reported regular menstrual cycles for the last 2 years
Who cannot join
- BP>140/90 mmHg
- BMI>40 kg/m2
- Diabetes
- Familial hypercholesterolemia
- Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
- Women must not be pregnant, plan to become pregnant during the study, or be nursing
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- Active renal or liver disease
- All medications and supplements that influence dependent variables*
- Recent surgery < 2 months
- Alcohol abuse
- Sleep apnea
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
To test the effect of limb occlusion pressure attainment in the supine, seated, and standing position on exercise performance, vascular physiology, and muscle.
Read the detailed description
The purpose of this study is to investigate the attainment of limb occlusion pressure (LOP)in the supine, seated, and standing positions on indices of arterial stiffness, muscle morphology, participant perception, and performance responses. Thirty adults aged 18-40 will undergo four treatment sessions (control (no BFR), supine LOP, seated LOP, and standing LOP) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). All sessions will consist of four sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, perceptual responses, and exercise performance.
- Conditions
- Blood Flow Restriction (BFR) Training Effects, Arterial Stiffness, Blood Pressure, Muscle Morphology, Perceptions
- Being tested
- Delfi Training Device
- Keywords
- blood flow restriction training, arterial stiffness, rating of perceived effort, traing volume, rating of perceived discomfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfi Training DeviceDevice
Delfi (Vancouver, Canada) training devices will be used for exercise and testing sessions. Cuffs will be placed around the right and left proximal thigh. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration) following manufacturer specifications. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. The cuffs will maintain pressure during training and rest periods. The LOP will be reduced to 0% immediately after completing the last set.
| Study group | Role | What they receive |
|---|---|---|
| Supine Limb Occlusion Pressure | Experimental | In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. Receives: Device: Delfi Training Device |
| Seated Limb Occlusion Pressure | Experimental | In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. Receives: Device: Delfi Training Device |
| Standing Limb Occlusion Pressure | Experimental | In the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. Receives: Device: Delfi Training Device |
| No BFR cuff | Placebo comparator | Four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals with no BFR cuffs Receives: Device: Delfi Training Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Non-invasive pulse tonometers (Complior Analytic Tonometer, Alam Medical, Vincennes, France) will be used to simultaneously obtain arterial pressure waveforms at the carotid, brachial, radial and femoral arteries throughout ten cardiac cycles. Surface distance between the two recording sites will be measured to the nearest 0.5 cm. Subsequently, this process is repeated to measure arterial pressure waveforms at the carotid and radial arteries. Pulse wave velocity for the carotid-femoral (aortic PWV) and carotid-radial (brachial PWV) recordings will be determined by normalizing the waveform foot-to-foot time delay to the distance between recording sites (i.e., PWV = D (cm)/Δt (sec)). The participant will remain supine exactly as they were positioned during the tonometry acquisition sequence. An enlarged caliper will be used to measure the distance between the carotid and radial tonometer, and the distance between the carotid and femoral tonometer.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Muscle Morphology
Participants' muscle cross-sectional area (mCSA) and echo intensity (EI) of the vastus lateralis (VL) muscle will be assessed using a brightness mode (B-mode) of the ultrasound imaging system (Terason t3300, MA, USA) and a multi-frequency linear-array probe (Model 15L4 Smart Mark 4-15 MHz, 50-mm field of view). All ultrasonic scans will be conducted on the participants' right arm to measure the mCSA and EI of the VL. Each participant will be instructed to lay in a supine position with their shoulder abducted at 90 degree and elbow flexed at 90 degrees. The VL measurements will be obtained from their right leg at 50% of the distance between the greater tubercle and lateral epicondyle. Locations of measurements will be marked with indelible ink to ensure scans will be taken at the same area for all scans. During every scan, water soluble gel will be applied on the skin and ultrasound probe to maximize acoustic coupling and reduce near-field artifacts.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction (BFR) Training EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teri Herberger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teri Herberger, Salisbury University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718582
- Sponsor's protocol ID
- #430
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2024
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dissemination of data will occur after publication upon request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Limb Occlusion Pressure Attainment on Cardiovascular, Perceptual, and Performance Responses
- ClinicalTrials.gov ID
- NCT06718582
- Acronym / sponsor ID
- #430
- Conditions
- Blood Flow Restriction (BFR) Training Effects, Arterial Stiffness, Blood Pressure, Muscle Morphology, Perceptions
- Keywords
- blood flow restriction training, arterial stiffness, rating of perceived effort, traing volume, rating of perceived discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Teri HerbergerUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effect of limb occlusion pressure attainment in the supine, seated, and standing position on exercise performance, vascular physiology, and muscle.
Detailed description
The purpose of this study is to investigate the attainment of limb occlusion pressure (LOP)in the supine, seated, and standing positions on indices of arterial stiffness, muscle morphology, participant perception, and performance responses. Thirty adults aged 18-40 will undergo four treatment sessions (control (no BFR), supine LOP, seated LOP, and standing LOP) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). All sessions will consist of four sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, perceptual responses, and exercise performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine Limb Occlusion Pressure | Experimental | Device: Delfi Training DeviceIn the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. |
| Seated Limb Occlusion Pressure | Experimental | Device: Delfi Training DeviceIn the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. |
| Standing Limb Occlusion Pressure | Experimental | Device: Delfi Training DeviceIn the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. |
| No BFR cuff | Placebo comparator | Device: Delfi Training DeviceFour sets of dumbbell wall squats will be performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals with no BFR cuffs |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physically active (> 1,000 MET/min/wk) for at least six months. Weight stable for previous 6 months (+/-2.5 kg) Female subjects only- reported regular menstrual cycles for the last 2 years
Key exclusion criteria (12 listed)
- BP>140/90 mmHg
- BMI>40 kg/m2
- Diabetes
- Familial hypercholesterolemia
- Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delfi Training DeviceDelfi (Vancouver, Canada) training devices will be used for exercise and testing sessions. Cuffs will be placed around the right and left proximal thigh. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration) following manufacturer specifications. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. The cuffs will maintain pressure during training and rest periods. The LOP will be reduced to 0% immediately after completing the last set. | Device | No BFR cuff, Seated Limb Occlusion Pressure, Standing Limb Occlusion Pressure, Supine Limb Occlusion Pressure |
Primary outcome
Arterial Stiffness
Time frame: From enrollment to the end of treatment at 4 weeks
Non-invasive pulse tonometers (Complior Analytic Tonometer, Alam Medical, Vincennes, France) will be used to simultaneously obtain arterial pressure waveforms at the carotid, brachial, radial and femoral arteries throughout ten cardiac cycles. Surface distance between the two recording sites will be measured to the nearest 0.5 cm. Subsequently, this process is repeated to measure arterial pressure waveforms at the carotid and radial arteries. Pulse wave velocity for the carotid-femoral (aortic PWV) and carotid-radial (brachial PWV) recordings will be determined by normalizing the waveform foot-to-foot time delay to the distance between recording sites (i.e., PWV = D (cm)/Δt (sec)). The participant will remain supine exactly as they were positioned during the tonometry acquisition sequence. An enlarged caliper will be used to measure the distance between the carotid and radial tonometer, and the distance between the carotid and femoral tonometer.
1 secondary outcome
Muscle Morphology
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Individual participant dataSharing planned: Yes. Dissemination of data will occur after publication upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delfi Training Device in people with Blood Flow Restriction (BFR) Training Effects and Arterial Stiffness, Blood Pressure, run by Teri Herberger at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.