Blood Flow Restriction (BFR) Training EffectsNCT07213726
Quantification of Progenitor Cell Circulation Following Vascular Resistance Exercise Using Delfi Tourniquet System
A study testing Delfi Personalized Tourniquet System in people with Blood Flow Restriction (BFR) Training Effects, run by Andrews Research & Education Foundation at 1 site in United States.
Trial summary
The purpose of this observational study is to examine how slowing down blood flow to the legs- a practice called blood flow restriction (BFR)- during exercise by applying compression to the legs affects the way stem cells are released into the blood stream. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction (BFR) Training Effects
- What is being tested?
- Delfi Personalized Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 20 Nov 2026
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer population of healthy males and females aged 18-45.
- Subjects consent to attending a total of 14 visits over a time span of seven to nine weeks. The breakdown of the 14 visits is as follows: 1 familiarization session, 12 experimental testing sessions, 1 final session.
Who cannot join
- Volunteers who have medical history involving one or more of the following medical conditions:
- Diabetes
- Uncontrolled hypertension
- Autoimmune disorders
- Blood disorders
- Ongoing infectious disease
Show all 12Show fewer
- Cancer
- Any disorder requiring immunosuppression treatment
- Steroid usage
- Significant cardiovascular, pulmonary, hepatic, or renal disease.
- Volunteers where 20 minutes of intense exercise is contra-indicated will also be excluded from the study.
- Positive pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Andrews Institute for Orthopaedics & Sports Medicine
Gulf Breeze, Florida, 32561
About this study
Official title: Quantification of Peripheral Hematopoietic Progenitor Cell Circulation Following Repeated Acute, Vascular Restriction Resistance Exercise Using the Delfi Tourniquet System
The purpose of this observational study is to examine how slowing down blood flow to the legs- a practice called blood flow restriction (BFR)- during exercise by applying compression to the legs affects the way stem cells are released into the blood stream. This will be determined by drawing 6 cubic centimeters (ccs) of blood immediately post-exercise after the Delfi Personalized Tourniquet System (PTS) has been removed. 6 ccs of blood will also be taken prior to exercise and at the 20-, 40-, and 60-minute marks after exercise. The main question of this study is:
- Will the levels of stem cells extracted before and after exercise be the same if blood flow is restricted during exercise?
Read more
In this study, participants will undergo the following:
- 6 ccs of blood extracted from the forearm prior to exercise to establish a baseline
- 3 exercises- seated leg extension, semi-reclined leg press, and seated hamstring curl- consisting of 4 sets of 30-15-15-15 repetitions per exercise; resistance will be set to 30% of one-rep maximum (1-RM)
- Additional 6 cc blood draws will be performed immediately post-exercise and after 20, 40, and 60 minutes have elapsed
Read the detailed description
The proposed study is a prospective, quasi-experiment, dual-center (exercise facility and laboratory) study involving 15 healthy, male and female volunteers. A potential subject must clear the screening, consent to the procedures of this study, and complete the medical interview before proceeding with the familiarization session. The familiarization process will include an introduction to the Delfi BFR Tourniquet System (Delfi Medical Innovations Inc., Vancouver, BC) and the exercises (seated leg extension, semi-reclined leg press, seated hamstring curl) that the subject will complete. The weight each subject will use for each exercise will be determined during this time. All familiarization procedures must be completed prior to the scheduling and execution of the first of twelve experimental testing sessions.
The experimental testing sessions will occur twice a week for six weeks (12 sessions) and will involve the BFR training utilizing the Delfi BFR Tourniquet System, as further described in the Experimental Testing Session section of the treatment plan (6.2). At the beginning of the first, the sixth, and the twelfth testing sessions there will be a blood draw requiring 6 cc of blood to be taken prior to exercise. Post-exercise, at each testing session, additional 6cc blood draws will be conducted immediately post exercise (time point 0), as well as 20- , 40- , and 60 minutes after the conclusion of the workout. Following every testing session workout, finger-prick blood samples for lactate testing will be taken. These blood samples are to be taken at Time point 0- (T 0), 10-, 20-, 30-, 40-, 50-, and 60-minutes following exercise. Once the twelfth experimental testing session has been completed, the subjects will have one final session that is to take place no more than five days following the twelfth testing session. This final session will include one final blood draw of 6 cc. Throughout the duration of the study, the blood drawn will be used for obtaining a complete blood count (CBC) and for cellular analysis to quantify peripheral hematopoietic progenitor cell concentration. The blood samples collected from subject's fingers throughout the study will be used for analysis using a portable lactate analyzer. Lactate analysis will allow researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
- Being tested
- Delfi Personalized Tourniquet System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfi Personalized Tourniquet SystemDevice
Bilateral proximal thigh bands that will be applied and inflated to a pressure of 80% of occlusive pressure as determined by the automated tourniquet before exercise. A standard exercise session would not include any blood occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | This group consists of all participants in this study. Subjects must be healthy, and gender is not a factor for enrollment. Receives: Device: Delfi Personalized Tourniquet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 1 week after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 2 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 3 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 4 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 5 weeks after enrollment
Concentration of Blood Lactate
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Measured: 6 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 1 week after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 2 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 3 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 4 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 5 weeks after enrollment
Prevalence of Hematopoietic Stem Cells
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Measured: 6 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start16 Aug 2022
- Primary completion20 Nov 2023
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrews Research & Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida
- Responsible party
- Sponsor
- Investigators
- Tyler Opitz, DPT, SCS, CSCS, Principal investigator, Physical Therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213726
- Sponsor's protocol ID
- Extended Delfi
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weissman IL, Shizuru JA. The origins of the identification and isolation of hematopoietic stem cells, and their capability to induce donor-specific transplantation tolerance and treat autoimmune diseases. Blood. 2008 Nov 1;112(9):3543-53. doi: 10.1182/blood-2008-08-078220.
PubMed 18948588Zakrzewski JL, van den Brink MR, Hubbell JA. Overcoming immunological barriers in regenerative medicine. Nat Biotechnol. 2014 Aug;32(8):786-94. doi: 10.1038/nbt.2960.
PubMed 25093888Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
PubMed 1870029Marycz K, Mierzejewska K, Smieszek A, Suszynska E, Malicka I, Kucia M, Ratajczak MZ. Endurance Exercise Mobilizes Developmentally Early Stem Cells into Peripheral Blood and Increases Their Number in Bone Marrow: Implications for Tissue Regeneration. Stem Cells Int. 2016;2016:5756901. doi: 10.1155/2016/5756901. Epub 2015 Nov 9.
PubMed 26664409Agha NH, Baker FL, Kunz HE, Graff R, Azadan R, Dolan C, Laughlin MS, Hosing C, Markofski MM, Bond RA, Bollard CM, Simpson RJ. Vigorous exercise mobilizes CD34+ hematopoietic stem cells to peripheral blood via the beta2-adrenergic receptor. Brain Behav Immun. 2018 Feb;68:66-75. doi: 10.1016/j.bbi.2017.10.001. Epub 2017 Oct 7.
PubMed 29017969Callanan MC, Plummer HA, Chapman GL, Opitz TJ, Rendos NK, Anz AW. Blood Flow Restriction Training Using the Delfi System Is Associated With a Cellular Systemic Response. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e189-e198. doi: 10.1016/j.asmr.2020.09.009. eCollection 2021 Feb.
PubMed 33615264Hwang NS, Zhang C, Hwang YS, Varghese S. Mesenchymal stem cell differentiation and roles in regenerative medicine. Wiley Interdiscip Rev Syst Biol Med. 2009 Jul-Aug;1(1):97-106. doi: 10.1002/wsbm.26.
PubMed 20835984Docheva D, Popov C, Mutschler W, Schieker M. Human mesenchymal stem cells in contact with their environment: surface characteristics and the integrin system. J Cell Mol Med. 2007 Jan-Feb;11(1):21-38. doi: 10.1111/j.1582-4934.2007.00001.x.
PubMed 17367499Rochefort GY, Delorme B, Lopez A, Herault O, Bonnet P, Charbord P, Eder V, Domenech J. Multipotential mesenchymal stem cells are mobilized into peripheral blood by hypoxia. Stem Cells. 2006 Oct;24(10):2202-8. doi: 10.1634/stemcells.2006-0164. Epub 2006 Jun 15.
PubMed 16778152Hylden C, Burns T, Stinner D, Owens J. Blood flow restriction rehabilitation for extremity weakness: a case series. J Spec Oper Med. 2015 Spring;15(1):50-6.
PubMed 25770798Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
PubMed 11128848Vechin FC, Libardi CA, Conceicao MS, Damas FR, Lixandrao ME, Berton RP, Tricoli VA, Roschel HA, Cavaglieri CR, Chacon-Mikahil MP, Ugrinowitsch C. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015 Apr;29(4):1071-6. doi: 10.1519/JSC.0000000000000703.
PubMed 25264670Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
PubMed 10846023Feriche B, Garcia-Ramos A, Morales-Artacho AJ, Padial P. Resistance Training Using Different Hypoxic Training Strategies: a Basis for Hypertrophy and Muscle Power Development. Sports Med Open. 2017 Dec;3(1):12. doi: 10.1186/s40798-017-0078-z. Epub 2017 Mar 17.
PubMed 28315193Kaijser L, Sundberg CJ, Eiken O, Nygren A, Esbjornsson M, Sylven C, Jansson E. Muscle oxidative capacity and work performance after training under local leg ischemia. J Appl Physiol (1985). 1990 Aug;69(2):785-7. doi: 10.1152/jappl.1990.69.2.785.
PubMed 2146245
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Peripheral Hematopoietic Progenitor Cell Circulation Following Repeated Acute, Vascular Restriction Resistance Exercise Using the Delfi Tourniquet System
- ClinicalTrials.gov ID
- NCT07213726
- Acronym / sponsor ID
- Extended Delfi
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Andrews Research & Education FoundationUniversity, hospital or other
- Collaborators
- Florida
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 9 Oct 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.
The purpose of this observational study is to examine how slowing down blood flow to the legs- a practice called blood flow restriction (BFR)- during exercise by applying compression to the legs affects the way stem cells are released into the blood stream. This will be determined by drawing 6 cubic centimeters (ccs) of blood immediately post-exercise after the Delfi Personalized Tourniquet System (PTS) has been removed. 6 ccs of blood will also be taken prior to exercise and at the 20-, 40-, and 60-minute marks after exercise. The main question of this study is:
- Will the levels of stem cells extracted before and after exercise be the same if blood flow is restricted during exercise?
In this study, participants will undergo the following:
- 6 ccs of blood extracted from the forearm prior to exercise to establish a baseline
- 3 exercises- seated leg extension, semi-reclined leg press, and seated hamstring curl- consisting of 4 sets of 30-15-15-15 repetitions per exercise; resistance will be set to 30% of one-rep maximum (1-RM)
- Additional 6 cc blood draws will be performed immediately post-exercise and after 20, 40, and 60 minutes have elapsed
Detailed description
The proposed study is a prospective, quasi-experiment, dual-center (exercise facility and laboratory) study involving 15 healthy, male and female volunteers. A potential subject must clear the screening, consent to the procedures of this study, and complete the medical interview before proceeding with the familiarization session. The familiarization process will include an introduction to the Delfi BFR Tourniquet System (Delfi Medical Innovations Inc., Vancouver, BC) and the exercises (seated leg extension, semi-reclined leg press, seated hamstring curl) that the subject will complete. The weight each subject will use for each exercise will be determined during this time. All familiarization procedures must be completed prior to the scheduling and execution of the first of twelve experimental testing sessions.
The experimental testing sessions will occur twice a week for six weeks (12 sessions) and will involve the BFR training utilizing the Delfi BFR Tourniquet System, as further described in the Experimental Testing Session section of the treatment plan (6.2). At the beginning of the first, the sixth, and the twelfth testing sessions there will be a blood draw requiring 6 cc of blood to be taken prior to exercise. Post-exercise, at each testing session, additional 6cc blood draws will be conducted immediately post exercise (time point 0), as well as 20- , 40- , and 60 minutes after the conclusion of the workout. Following every testing session workout, finger-prick blood samples for lactate testing will be taken. These blood samples are to be taken at Time point 0- (T 0), 10-, 20-, 30-, 40-, 50-, and 60-minutes following exercise. Once the twelfth experimental testing session has been completed, the subjects will have one final session that is to take place no more than five days following the twelfth testing session. This final session will include one final blood draw of 6 cc. Throughout the duration of the study, the blood drawn will be used for obtaining a complete blood count (CBC) and for cellular analysis to quantify peripheral hematopoietic progenitor cell concentration. The blood samples collected from subject's fingers throughout the study will be used for analysis using a portable lactate analyzer. Lactate analysis will allow researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Device: Delfi Personalized Tourniquet SystemThis group consists of all participants in this study. Subjects must be healthy, and gender is not a factor for enrollment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Volunteer population of healthy males and females aged 18-45.
- Subjects consent to attending a total of 14 visits over a time span of seven to nine weeks. The breakdown of the 14 visits is as follows: 1 familiarization session, 12 experimental testing sessions, 1 final session.
Key exclusion criteria (12 listed)
- Volunteers who have medical history involving one or more of the following medical conditions:
- Diabetes
- Uncontrolled hypertension
- Autoimmune disorders
- Blood disorders
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 Personalized Tourniquet SystemBilateral proximal thigh bands that will be applied and inflated to a pressure of 80% of occlusive pressure as determined by the automated tourniquet before exercise. A standard exercise session would not include any blood occlusion. | Device | Healthy |
Primary outcome
Concentration of Blood Lactate
Time frame: 1 week after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Concentration of Blood Lactate
Time frame: 2 weeks after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Concentration of Blood Lactate
Time frame: 3 weeks after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Concentration of Blood Lactate
Time frame: 4 weeks after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Concentration of Blood Lactate
Time frame: 5 weeks after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Concentration of Blood Lactate
Time frame: 6 weeks after enrollment
Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected.
Prevalence of Hematopoietic Stem Cells
Time frame: 1 week after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Prevalence of Hematopoietic Stem Cells
Time frame: 2 weeks after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Prevalence of Hematopoietic Stem Cells
Time frame: 3 weeks after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Prevalence of Hematopoietic Stem Cells
Time frame: 4 weeks after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Prevalence of Hematopoietic Stem Cells
Time frame: 5 weeks after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
Prevalence of Hematopoietic Stem Cells
Time frame: 6 weeks after enrollment
Technique completed using special machine that utilizes lasers to separate and quantify various content of cell samples; used in this study to determine complete blood cell count (CBC) and peripheral hematopoietic progenitor cell concentration
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 8 Dec 2025.
- Background: PubMed 18948588Weissman IL, Shizuru JA. The origins of the identification and isolation of hematopoietic stem cells, and their capability to induce donor-specific transplantation tolerance and treat autoimmune diseases. Blood. 2008 Nov 1;112(9):3543-53. doi: 10.1182/blood-2008-08-078220.
- Background: PubMed 25093888Zakrzewski JL, van den Brink MR, Hubbell JA. Overcoming immunological barriers in regenerative medicine. Nat Biotechnol. 2014 Aug;32(8):786-94. doi: 10.1038/nbt.2960.
- Background: PubMed 1870029Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504.
- Background: PubMed 26664409Marycz K, Mierzejewska K, Smieszek A, Suszynska E, Malicka I, Kucia M, Ratajczak MZ. Endurance Exercise Mobilizes Developmentally Early Stem Cells into Peripheral Blood and Increases Their Number in Bone Marrow: Implications for Tissue Regeneration. Stem Cells Int. 2016;2016:5756901. doi: 10.1155/2016/5756901. Epub 2015 Nov 9.
- Background: PubMed 29017969Agha NH, Baker FL, Kunz HE, Graff R, Azadan R, Dolan C, Laughlin MS, Hosing C, Markofski MM, Bond RA, Bollard CM, Simpson RJ. Vigorous exercise mobilizes CD34+ hematopoietic stem cells to peripheral blood via the beta2-adrenergic receptor. Brain Behav Immun. 2018 Feb;68:66-75. doi: 10.1016/j.bbi.2017.10.001. Epub 2017 Oct 7.
- Background: PubMed 33615264Callanan MC, Plummer HA, Chapman GL, Opitz TJ, Rendos NK, Anz AW. Blood Flow Restriction Training Using the Delfi System Is Associated With a Cellular Systemic Response. Arthrosc Sports Med Rehabil. 2020 Dec 27;3(1):e189-e198. doi: 10.1016/j.asmr.2020.09.009. eCollection 2021 Feb.
- Background: PubMed 20835984Hwang NS, Zhang C, Hwang YS, Varghese S. Mesenchymal stem cell differentiation and roles in regenerative medicine. Wiley Interdiscip Rev Syst Biol Med. 2009 Jul-Aug;1(1):97-106. doi: 10.1002/wsbm.26.
- Background: PubMed 17367499Docheva D, Popov C, Mutschler W, Schieker M. Human mesenchymal stem cells in contact with their environment: surface characteristics and the integrin system. J Cell Mol Med. 2007 Jan-Feb;11(1):21-38. doi: 10.1111/j.1582-4934.2007.00001.x.
- Background: PubMed 16778152Rochefort GY, Delorme B, Lopez A, Herault O, Bonnet P, Charbord P, Eder V, Domenech J. Multipotential mesenchymal stem cells are mobilized into peripheral blood by hypoxia. Stem Cells. 2006 Oct;24(10):2202-8. doi: 10.1634/stemcells.2006-0164. Epub 2006 Jun 15.
- Background: PubMed 25770798Hylden C, Burns T, Stinner D, Owens J. Blood flow restriction rehabilitation for extremity weakness: a case series. J Spec Oper Med. 2015 Spring;15(1):50-6.
- Background: PubMed 11128848Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.
- Background: PubMed 25264670Vechin FC, Libardi CA, Conceicao MS, Damas FR, Lixandrao ME, Berton RP, Tricoli VA, Roschel HA, Cavaglieri CR, Chacon-Mikahil MP, Ugrinowitsch C. Comparisons between low-intensity resistance training with blood flow restriction and high-intensity resistance training on quadriceps muscle mass and strength in elderly. J Strength Cond Res. 2015 Apr;29(4):1071-6. doi: 10.1519/JSC.0000000000000703.
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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.
Tyler Opitz, DPT, SCS, CSCS principal investigator
Physical Therapist
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 Personalized Tourniquet System in people with Blood Flow Restriction (BFR) Training Effects, run by Andrews Research & Education Foundation 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 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 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. 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?
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?
Concentration of Blood Lactate (time frame: 1 week after enrollment). The study lists 12 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 NCT07213726, which also lists 32 linked publications.
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 8 Dec 2025.