Blood Vessel DiseaseNCT06276673
The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs
A study testing Delfi in people with Blood Vessel Disease and Muscle Edema, run by Salisbury University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, 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
- Blood Vessel Disease, Muscle Edema
- What is being tested?
- Delfi
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to 10 Dec 2024
- 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
Official title: The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs on Post-exercise Arterial Stiffness, Perceptual Responses and Performance
The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception.
Read the detailed description
Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), SC BFR, and MC 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, ultrasonography of the carotid artery, 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 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 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
- Blood Vessel Disease, Muscle Edema
- Being tested
- Delfi
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelfiDevice
Also called B-Strong
Cuffs will be worn throughout the entire training session. Training session consist of lower intensity wall squats. Four sets of wall squats will be performed to failure. Arterial stiffness and muscle morphological assessments will be conducted before and after the exercise.
| Study group | Role | What they receive |
|---|---|---|
| single chamber blood flow restriction cuff | Experimental | Single Chamber BFR (Delfi, Vancouver, Canada) training devices will be used for exercise and testing sessions (see attachment). 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) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed. Receives: Device: Delfi |
| Multiple chamber blood flow restriction cuff | Experimental | Multiple chamber BFR (B-Strong, Park City, UT) training devices will be used for exercise and testing sessions (see attachment). 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) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed. Receives: Device: Delfi |
| No BFR cuff | Placebo comparator | No cuff will be worn during the training session. Receives: Device: Delfi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
A measurement of vascular health.
Measured: Prior to and 10-minutes after the exercise intervention
Muscle Morphology
A measurement of vastus lateralis cross sectional area
Measured: Prior to and immediately 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 posted26 Feb 2024
- Study start13 Feb 2024
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Vessel DiseaseStudies 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
- Model description
- Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week.
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT06276673
- Sponsor's protocol ID
- 301
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The plan is to share data when requested
Publications
Rolnick N, de Queiros VS, Moghaddam M, Peikon E, Taylor S, Watson S, Ruffhead C, Zupnik S, Werner T. Cardiovascular, perceptual, and performance responses to single- vs. multi-chambered blood flow restriction cuffs. Front Sports Act Living. 2024 Nov 14;6:1469356. doi: 10.3389/fspor.2024.1469356. eCollection 2024.
PubMed 39610655
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs on Post-exercise Arterial Stiffness, Perceptual Responses and Performance
- ClinicalTrials.gov ID
- NCT06276673
- Acronym / sponsor ID
- 301
- Conditions
- Blood Vessel Disease, Muscle Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Salisbury UniversityUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 26 Feb 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.
The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception.
Detailed description
Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), SC BFR, and MC 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, ultrasonography of the carotid artery, 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 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 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
- Model description
- Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week.
| Arm | Type | Receives |
|---|---|---|
| single chamber blood flow restriction cuff | Experimental | Device: DelfiSingle Chamber BFR (Delfi, Vancouver, Canada) training devices will be used for exercise and testing sessions (see attachment). 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) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed. |
| Multiple chamber blood flow restriction cuff | Experimental | Device: DelfiMultiple chamber BFR (B-Strong, Park City, UT) training devices will be used for exercise and testing sessions (see attachment). 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) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed. |
| No BFR cuff | Placebo comparator | Device: DelfiNo cuff will be worn during the training session. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 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 |
|---|---|---|
| DelfiAlso: B-StrongCuffs will be worn throughout the entire training session. Training session consist of lower intensity wall squats. Four sets of wall squats will be performed to failure. Arterial stiffness and muscle morphological assessments will be conducted before and after the exercise. | Device | Multiple chamber blood flow restriction cuff, No BFR cuff, single chamber blood flow restriction cuff |
Primary outcome
Arterial Stiffness
Time frame: Prior to and 10-minutes after the exercise intervention
A measurement of vascular health.
Muscle Morphology
Time frame: Prior to and immediately after the exercise intervention
A measurement of vastus lateralis cross sectional area
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 39610655Rolnick N, de Queiros VS, Moghaddam M, Peikon E, Taylor S, Watson S, Ruffhead C, Zupnik S, Werner T. Cardiovascular, perceptual, and performance responses to single- vs. multi-chambered blood flow restriction cuffs. Front Sports Act Living. 2024 Nov 14;6:1469356. doi: 10.3389/fspor.2024.1469356. eCollection 2024.
- Individual participant dataSharing planned: Yes. The plan is to share data when requested
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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 in people with Blood Vessel Disease and Muscle Edema, 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 3 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
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: Prior to and 10-minutes after the exercise intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276673, which also lists 1 linked publication.
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 26 Feb 2024.