Delfi CuffNCT07052227
The Influences of Blood Flow Restriction on Leg Press
A study testing Delfi blood flow restriction cuff and Fitcuffs in people with Delfi Cuff and Fitcuff, run by Salisbury University at 1 site in United States.
Trial summary
This study will investigate the use of different blood flow restriction cuffs during leg press exercise on arterial stiffness, muscle morphology, performance, and participant perception. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Delfi Cuff, Fitcuff, Placebo - Control
- What is being tested?
- Delfi blood flow restriction cuff and Fitcuffs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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)
Who cannot join
- Stage 2 hypertension (SBP >/= 140 and/or DBP >/= 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.
- Participants 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Salisbury University
Salisbury, Maryland, 21801
Tim Werner, 740-434-7720, tjwerner@salisbury.edu
About this study
Official title: The Influences of Blood Flow Restriction on Leg Press Perceptual Responses and Performance, and Systemic Arterial Stiffness
This study will investigate the use of different blood flow restriction cuffs during leg press exercise on arterial stiffness, muscle morphology, performance, and participant perception.
Read the detailed description
This study aims to investigate the use of Delfi vs. Fitcuffs blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, performance, and participant perception. Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), Delfi BFR, and Fitcuffs BFR) 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, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of leg press exercises performed to failure with a 2-second concentric and 2-second eccentric cadence at 20% of their 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. 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, and perceptual response.
- Conditions
- Delfi Cuff, Fitcuff, Placebo - Control
- Being tested
- Delfi blood flow restriction cuff, Fitcuffs, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfi blood flow restriction cuffDevice
Leg press exercise with Delfi blood flow restriction cuff
FitcuffsDevice
Leg press exercise with Fitcuff blood flow restriction cuff
ControlOther
Leg press exercise with no blood flow restriction cuff
| Study group | Role | What they receive |
|---|---|---|
| Delfi | Experimental | Not described Receives: Device: Delfi blood flow restriction cuff |
| Fitcuff | Experimental | Not described Receives: Device: Fitcuffs |
| Control | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Measured: 10 minutes before and 10 minutes after the exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion14 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delfi CuffStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salisbury University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Werner, Salisbury University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052227
- Sponsor's protocol ID
- #492
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel spreadsheet with data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Blood Flow Restriction on Leg Press Perceptual Responses and Performance, and Systemic Arterial Stiffness
- ClinicalTrials.gov ID
- NCT07052227
- Acronym / sponsor ID
- #492
- Conditions
- Delfi Cuff, Fitcuff, Placebo - Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Salisbury UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 14 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 4 Jul 2025 (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.
This study will investigate the use of different blood flow restriction cuffs during leg press exercise on arterial stiffness, muscle morphology, performance, and participant perception.
Detailed description
This study aims to investigate the use of Delfi vs. Fitcuffs blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, performance, and participant perception. Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), Delfi BFR, and Fitcuffs BFR) 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, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of leg press exercises performed to failure with a 2-second concentric and 2-second eccentric cadence at 20% of their 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. 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, and perceptual response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delfi | Experimental | Device: Delfi blood flow restriction cuff |
| Fitcuff | Experimental | Device: Fitcuffs |
| Control | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physically active (> 1,000 MET/min/wk) for at least six months.
- Weight stable for previous 6 months (+/-2.5 kg)
Key exclusion criteria (11 listed)
- Stage 2 hypertension (SBP >/= 140 and/or DBP >/= 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 blood flow restriction cuffLeg press exercise with Delfi blood flow restriction cuff | Device | Delfi |
| FitcuffsLeg press exercise with Fitcuff blood flow restriction cuff | Device | Fitcuff |
| ControlLeg press exercise with no blood flow restriction cuff | Other | Control |
Primary outcome
Pulse wave velocity
Time frame: 10 minutes before and 10 minutes after the exercise intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes. Excel spreadsheet with data will be shared upon request.
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.
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 blood flow restriction cuff and Fitcuffs in people with Delfi Cuff and Fitcuff, run by Salisbury University 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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 4 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Werner, PhD (410-548-3526, tjwerner@salisbury.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (time frame: 10 minutes before and 10 minutes after the exercise intervention). 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 4 Jul 2025.