Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Florida | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy | Experimental | This group consists of all participants in this study. Subjects must be healthy, and gender is not a factor for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delfi Personalized Tourniquet System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Blood Lactate | Allows researchers insight into each subject's exertion level reflected by the amount of lactate found within the samples collected. | 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. | 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. | 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. | 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. | 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. | 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 |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Volunteers who have medical history involving one or more of the following medical conditions:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tyler Opitz, DPT, SCS, CSCS | Physical Therapist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Institute for Orthopaedics & Sports Medicine | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18948588 | Background | 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. | |
| 25093888 | Background | Zakrzewski 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. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2022 | Jan 30, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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 | 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 | 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 | 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 | 6 weeks after enrollment |
| 1870029 | Background | Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991 Sep;9(5):641-50. doi: 10.1002/jor.1100090504. |
| 26664409 | Background | Marycz 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. |
| 29017969 | Background | Agha 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. |
| 33615264 | Background | Callanan 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. |
| 20835984 | Background | Hwang 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. |
| 17367499 | Background | Docheva 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. |
| 16778152 | Background | Rochefort 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. |
| 25770798 | Background | Hylden 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. |
| 11128848 | Background | Takarada 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. |
| 25264670 | Background | Vechin 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. |
| 10846023 | Background | Takarada 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. |
| 28315193 | Background | Feriche 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. |
| 2146245 | Background | Kaijser 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. |
| 25603897 | Background | Farup J, de Paoli F, Bjerg K, Riis S, Ringgard S, Vissing K. Blood flow restricted and traditional resistance training performed to fatigue produce equal muscle hypertrophy. Scand J Med Sci Sports. 2015 Dec;25(6):754-63. doi: 10.1111/sms.12396. Epub 2015 Jan 21. |
| 26202071 | Background | Ellefsen S, Hammarstrom D, Strand TA, Zacharoff E, Whist JE, Rauk I, Nygaard H, Vegge G, Hanestadhaugen M, Wernbom M, Cumming KT, Ronning R, Raastad T, Ronnestad BR. Blood flow-restricted strength training displays high functional and biological efficacy in women: a within-subject comparison with high-load strength training. Am J Physiol Regul Integr Comp Physiol. 2015 Oct;309(7):R767-79. doi: 10.1152/ajpregu.00497.2014. Epub 2015 Jul 22. |
| 28706859 | Background | de Freitas MC, Gerosa-Neto J, Zanchi NE, Lira FS, Rossi FE. Role of metabolic stress for enhancing muscle adaptations: Practical applications. World J Methodol. 2017 Jun 26;7(2):46-54. doi: 10.5662/wjm.v7.i2.46. eCollection 2017 Jun 26. |
| 28966705 | Background | Vanwye WR, Weatherholt AM, Mikesky AE. Blood Flow Restriction Training: Implementation into Clinical Practice. Int J Exerc Sci. 2017 Sep 1;10(5):649-654. doi: 10.70252/LYGQ7085. eCollection 2017. |
| 22051111 | Background | Loenneke JP, Fahs CA, Rossow LM, Abe T, Bemben MG. The anabolic benefits of venous blood flow restriction training may be induced by muscle cell swelling. Med Hypotheses. 2012 Jan;78(1):151-4. doi: 10.1016/j.mehy.2011.10.014. Epub 2011 Nov 1. |
| 23446173 | Background | Wilson JM, Lowery RP, Joy JM, Loenneke JP, Naimo MA. Practical blood flow restriction training increases acute determinants of hypertrophy without increasing indices of muscle damage. J Strength Cond Res. 2013 Nov;27(11):3068-75. doi: 10.1519/JSC.0b013e31828a1ffa. |
| 22982712 | Background | Loenneke JP, Abe T, Wilson JM, Thiebaud RS, Fahs CA, Rossow LM, Bemben MG. Blood flow restriction: an evidence based progressive model (Review). Acta Physiol Hung. 2012 Sep;99(3):235-50. doi: 10.1556/APhysiol.99.2012.3.1. |
| 16902061 | Background | Reeves GV, Kraemer RR, Hollander DB, Clavier J, Thomas C, Francois M, Castracane VD. Comparison of hormone responses following light resistance exercise with partial vascular occlusion and moderately difficult resistance exercise without occlusion. J Appl Physiol (1985). 2006 Dec;101(6):1616-22. doi: 10.1152/japplphysiol.00440.2006. Epub 2006 Aug 10. |
| 21399959 | Background | Inagaki Y, Madarame H, Neya M, Ishii N. Increase in serum growth hormone induced by electrical stimulation of muscle combined with blood flow restriction. Eur J Appl Physiol. 2011 Nov;111(11):2715-21. doi: 10.1007/s00421-011-1899-y. Epub 2011 Mar 12. |
| 23338987 | Background | Schoenfeld BJ. Potential mechanisms for a role of metabolic stress in hypertrophic adaptations to resistance training. Sports Med. 2013 Mar;43(3):179-94. doi: 10.1007/s40279-013-0017-1. |
| 25249278 | Background | Pearson SJ, Hussain SR. A review on the mechanisms of blood-flow restriction resistance training-induced muscle hypertrophy. Sports Med. 2015 Feb;45(2):187-200. doi: 10.1007/s40279-014-0264-9. |
| 22727808 | Background | Manini TM, Yarrow JF, Buford TW, Clark BC, Conover CF, Borst SE. Growth hormone responses to acute resistance exercise with vascular restriction in young and old men. Growth Horm IGF Res. 2012 Oct;22(5):167-72. doi: 10.1016/j.ghir.2012.05.002. Epub 2012 Jun 23. |
| 15959798 | Background | Takano H, Morita T, Iida H, Asada K, Kato M, Uno K, Hirose K, Matsumoto A, Takenaka K, Hirata Y, Eto F, Nagai R, Sato Y, Nakajima T. Hemodynamic and hormonal responses to a short-term low-intensity resistance exercise with the reduction of muscle blood flow. Eur J Appl Physiol. 2005 Sep;95(1):65-73. doi: 10.1007/s00421-005-1389-1. Epub 2005 Jun 15. |
| 10642363 | Background | Takarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol (1985). 2000 Jan;88(1):61-5. doi: 10.1152/jappl.2000.88.1.61. |
| 24870580 | Background | Ganesan G, Cotter JA, Reuland W, Cerussi AE, Tromberg BJ, Galassetti P. Effect of blood flow restriction on tissue oxygenation during knee extension. Med Sci Sports Exerc. 2015 Jan;47(1):185-93. doi: 10.1249/MSS.0000000000000393. |
| 24715613 | Background | Scott BR, Slattery KM, Sculley DV, Dascombe BJ. Hypoxia and resistance exercise: a comparison of localized and systemic methods. Sports Med. 2014 Aug;44(8):1037-54. doi: 10.1007/s40279-014-0177-7. |
| 7607195 | Background | Narici MV, Kayser B. Hypertrophic response of human skeletal muscle to strength training in hypoxia and normoxia. Eur J Appl Physiol Occup Physiol. 1995;70(3):213-9. doi: 10.1007/BF00238566. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Oct 28, 2022 | ICF_001.pdf |