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

NCT03540147 | Terminated Results FDA Device

• 1 other identifier: 2017-10-0074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Training; Hemodynamic Response

Keywords

blood flow restriction; blood pressure; yoga

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (5)

Exercise with Hokanson cuffs

EXPERIMENTAL

Participants will walk on the treadmill with Hokanson cuffs inflated.

Device: Hokanson Cuffs

Exercise with BStrong Bands

EXPERIMENTAL

Participants will walk on the treadmill with BStrong bands inflated.

Device: BStrong Bands

Exercise without inflated bands/cuffs

SHAM COMPARATOR

Participants will walk on the treadmill with non-inflated BStrong bands.

Device: BStrong Bands

Yoga poses with BStrong bands inflated

EXPERIMENTAL

Participants will perform 15-20 yoga poses with BStrong bands inflated.

Device: BStrong Bands

Yoga poses with BStrong bands uninflated

SHAM COMPARATOR

Participants will perform 15-20 yoga poses with uninflated BStrong bands.

Device: BStrong Bands

Interventions

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.

Exercise with Hokanson cuffs

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.

Exercise with BStrong Bands; Exercise without inflated bands/cuffs; Yoga poses with BStrong bands inflated; Yoga poses with BStrong bands uninflated

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults

You may not qualify if:

• Pregnancy
• A recent illness, recent surgery, or any medical intervention
• history of diabetes, heart disease, or other cardiovascular problems

Sponsors & Collaborators

• University of Texas at Austin: lead
• Savannah Wooten: collaborator
• Stray-Gundersen, Sten, Ph.D.: collaborator

Study Sites (1)

Cardiovascular Aging Research Lab at UT Austin

Austin, Texas, 78712, United States

Location

Related Publications (7)

• 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.

  PMID: 19952840 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.

  PMID: 26246503 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.

  PMID: 26822582 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.

  PMID: 23738677 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.

  PMID: 23341425 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.

  PMID: 27633625 BACKGROUND

• 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.

  PMID: 32547424 DERIVED

Results Point of Contact

• Title: Hirofumi Tanaka
• Organization: University of Texas at Austin

htanaka@austin.utexas.edu

5122324801

Study Officials

• Hirofumi Tanaka, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know which condition they will receive on the day of testing.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 30, 2018
• Study Start: January 26, 2018
• Primary Completion: May 26, 2019
• Study Completion: May 26, 2019
• Last Updated: March 11, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The information is available now.
• Access Criteria: They will be available with a reasonable request to the investigators.

Locations

US (1)