The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses

Exercise Training Clinical Trial

Official title:

The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03540147
• Other study ID #: 2017-10-0074
• Status: Terminated
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: May 26, 2019

Study information

• Verified date: February 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 26, 2019
• Est. primary completion date: May 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adults

Exclusion Criteria:

• Pregnancy

• A recent illness, recent surgery, or any medical intervention

• history of diabetes, heart disease, or other cardiovascular problems

Related Conditions & MeSH terms

• Exercise Training
• Hemodynamic Response

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cardiovascular Aging Research Lab at UT Austin	Austin	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas at Austin	Savannah Wooten, Sten Stray-Gundersen

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Erratum in: J Phys Act Health. 2017 Jan;14 (1):76. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
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.	Before (baseline) and after the exercise interventions