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The number of subjects in this study was overestimated in the initial assessment.
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| Name | Class |
|---|---|
| Savannah Wooten | UNKNOWN |
| Stray-Gundersen, Sten, Ph.D. | INDIV |
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The impact of blood flow restriction (BFR) on exercise and hemodynamic responses will be studied. The use of BFR will be studied during yoga and low-intensity aerobic exercise in healthy subjects with no history of chronic illness ranging from 18-40 years of age. This study will evaluate several conditions related to cardiovascular physiology in order to determine the safety and efficacy of this type of exercise training. First, the effects of two distinct types of BFR cuffs (BStrong and Hokanson) will be studied during low-intensity aerobic exercise on vascular function. Second, the effect of yoga will be studied with and without the use of BStrong bands on vascular function. Outcome measures include acute effects on endothelial function i.e. flow-mediated dilation, arterial stiffness, beat-by-beat blood pressure, heart rate, RPE (rate of perceived exertion), and blood lactate. For this intervention, the BFR cuffs will be used during exercise to evaluate its safety and efficacy. Since BFR is becoming a widely popular method of exercise, it is important to study its safety and hemodynamic effects.
Participants will be tested a total of 5 times; twice for the yoga portion and thrice for the aerobic exercise (walking) portion. Outcome measures will be consistent across the five visits and will take approximately 2.5 hours to complete. The order of the five separate sessions will be randomized such that the participant cannot expect which condition they will be performing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise with Hokanson cuffs | Experimental | Participants will walk on the treadmill with Hokanson cuffs inflated. |
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| Exercise with BStrong Bands | Experimental | Participants will walk on the treadmill with BStrong bands inflated. |
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| Exercise without inflated bands/cuffs | Sham Comparator | Participants will walk on the treadmill with non-inflated BStrong bands. |
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| Yoga poses with BStrong bands inflated | Experimental | Participants will perform 15-20 yoga poses with BStrong bands inflated. |
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| Yoga poses with BStrong bands uninflated | Sham Comparator | Participants will perform 15-20 yoga poses with uninflated BStrong bands. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hokanson Cuffs | Device | Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Arterial blood pressure was measured using the automatic oscillometric methods. | Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation. |
| Flow-mediated Dilation | After 20 minutes of supine rest, endothelial function was measured via flow-mediated dilation (FMD) technique by measuring the brachial artery's diameter increase following a brief period of occlusion using an automated diagnostic ultrasound system. A blood pressure cuff was placed on the forearm with the proximal edge of the cuff above with the participant's antecubital fossa. Two cross-sectional images of the artery were acquired utilizing the automated ultrasound probe proximal to the antecubital fossa. Following baseline metrics, the cuff was inflated to 50 mmHg above resting systolic blood pressure for 5 minutes to occlude blood flow. After 5 minutes of occlusion, the cuff was deflated, and both brachial artery diameter and blood flow velocity were measured simultaneously and continuously for two-minutes immediately post occlusion. FMD was calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion. | Before (baseline) and after the exercise interventions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hirofumi Tanaka, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Aging Research Lab at UT Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19952840 | Background | Renzi CP, Tanaka H, Sugawara J. Effects of leg blood flow restriction during walking on cardiovascular function. Med Sci Sports Exerc. 2010 Apr;42(4):726-32. doi: 10.1249/MSS.0b013e3181bdb454. | |
| 26246503 | Background | Sugawara J, Tomoto T, Tanaka H. Impact of leg blood flow restriction during walking on central arterial hemodynamics. Am J Physiol Regul Integr Comp Physiol. 2015 Oct;309(7):R732-9. doi: 10.1152/ajpregu.00095.2015. Epub 2015 Aug 5. |
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IPD without identifying information will be shared with other investigators with a reasonable request to the investigators.
The information is available now.
They will be available with a reasonable request to the investigators.
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This is a cross-over study. Each subject performed all 5 experimental conditions that includes "exercise with Hokanson cuffs", "Exercise with BStrong bands", "Exercise without inflated bands/cuffs", "Yoga poses with BStrong bands inflated" and "Yoga poses with BStrong bands uninflated". The number of subjects studied is 20.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Flow Restriction Exercise | This is a cross-over study. Each subject performed all 5 experimental conditions that includes "exercise with Hokanson cuffs", "Exercise with BStrong bands", "Exercise without inflated bands/cuffs", "Yoga poses with BStrong bands inflated" and "Yoga poses with BStrong bands uninflated". |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Flow Restriction Exercise | Participants will walk on the treadmill with Hokanson cuffs inflated. Hokanson Cuffs: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | Arterial blood pressure was measured using the automatic oscillometric methods. | Baseline (before Experimental Arm Participation) data are reported below. | Posted | Mean | Standard Deviation | mmHg | Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation. |
|
Each participants came to the laboratory twice in the span of 2 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise With Hokanson Cuffs | Participants will walk on the treadmill with Hokanson cuffs inflated. Hokanson Cuffs: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hirofumi Tanaka | University of Texas at Austin | 5122324801 | htanaka@austin.utexas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2019 | Dec 21, 2020 | Prot_SAP_001.pdf |
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Each participant will undergo five visits to the laboratory for repeated testing under five different conditions. The sessions will be randomized and will take 2.5 hours to complete.
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The participants will not know which condition they will receive on the day of testing.
| BStrong Bands | Device | Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
|
| 26822582 | Background | Shimizu R, Hotta K, Yamamoto S, Matsumoto T, Kamiya K, Kato M, Hamazaki N, Kamekawa D, Akiyama A, Kamada Y, Tanaka S, Masuda T. Low-intensity resistance training with blood flow restriction improves vascular endothelial function and peripheral blood circulation in healthy elderly people. Eur J Appl Physiol. 2016 Apr;116(4):749-57. doi: 10.1007/s00421-016-3328-8. Epub 2016 Jan 28. |
| 23738677 | Background | Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. The effect of Bikram yoga on arterial stiffness in young and older adults. J Altern Complement Med. 2013 Dec;19(12):930-4. doi: 10.1089/acm.2012.0709. Epub 2013 Jun 5. |
| 23341425 | Background | Miles SC, Chun-Chung C, Hsin-Fu L, Hunter SD, Dhindsa M, Nualnim N, Tanaka H. Arterial blood pressure and cardiovascular responses to yoga practice. Altern Ther Health Med. 2013 Jan-Feb;19(1):38-45. |
| 27633625 | Background | Hunter SD, Dhindsa MS, Cunningham E, Tarumi T, Alkatan M, Nualnim N, Tanaka H. Impact of Hot Yoga on Arterial Stiffness and Quality of Life in Normal and Overweight/Obese Adults. J Phys Act Health. 2016 Dec;13(12):1360-1363. doi: 10.1123/jpah.2016-0170. Epub 2016 Aug 24. |
| 32547424 | Derived | Stray-Gundersen S, Wooten S, Tanaka H. Walking With Leg Blood Flow Restriction: Wide-Rigid Cuffs vs. Narrow-Elastic Bands. Front Physiol. 2020 May 29;11:568. doi: 10.3389/fphys.2020.00568. eCollection 2020. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
Participants will walk on the treadmill with BStrong bands inflated.
BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant.
| OG002 | Exercise Without Inflated Bands/Cuffs | Participants will walk on the treadmill with non-inflated BStrong bands. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
| OG003 | Yoga Poses With BStrong Bands Inflated | Participants will perform 15-20 yoga poses with BStrong bands inflated. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
| OG004 | Yoga Poses With BStrong Bands Uninflated | Participants will perform 15-20 yoga poses with uninflated BStrong bands. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. |
|
|
| Primary | Flow-mediated Dilation | After 20 minutes of supine rest, endothelial function was measured via flow-mediated dilation (FMD) technique by measuring the brachial artery's diameter increase following a brief period of occlusion using an automated diagnostic ultrasound system. A blood pressure cuff was placed on the forearm with the proximal edge of the cuff above with the participant's antecubital fossa. Two cross-sectional images of the artery were acquired utilizing the automated ultrasound probe proximal to the antecubital fossa. Following baseline metrics, the cuff was inflated to 50 mmHg above resting systolic blood pressure for 5 minutes to occlude blood flow. After 5 minutes of occlusion, the cuff was deflated, and both brachial artery diameter and blood flow velocity were measured simultaneously and continuously for two-minutes immediately post occlusion. FMD was calculated as a percent increase in brachial artery diameter at the post-blood flow occlusion compared with the pre-blood flow occlusion. | Posted | Mean | Standard Error | percentage of resting diameter | Before (baseline) and after the exercise interventions |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Exercise With BStrong Bands | Participants will walk on the treadmill with BStrong bands inflated. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Exercise Without Inflated Bands/Cuffs | Participants will walk on the treadmill with non-inflated BStrong bands. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Yoga Poses With BStrong Bands Inflated | Participants will perform 15-20 yoga poses with BStrong bands inflated. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Yoga Poses With BStrong Bands Uninflated | Participants will perform 15-20 yoga poses with uninflated BStrong bands. BStrong Bands: Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant. | 0 | 20 | 0 | 20 | 0 | 20 |
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| After conditions |
|