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

NCT ID: NCT03540147

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2019-05-26

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.

Detailed 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.

Conditions

Exercise Training; Hemodynamic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Exercise with Hokanson cuffs

Participants will walk on the treadmill with Hokanson cuffs inflated.

Group Type: EXPERIMENTAL

Hokanson Cuffs

Intervention Type: 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 BStrong Bands

Participants will walk on the treadmill with BStrong bands inflated.

Group Type: EXPERIMENTAL

BStrong Bands

Intervention Type: 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 without inflated bands/cuffs

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

Group Type: SHAM_COMPARATOR

BStrong Bands

Intervention Type: 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.

Yoga poses with BStrong bands inflated

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

Group Type: EXPERIMENTAL

BStrong Bands

Intervention Type: 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.

Yoga poses with BStrong bands uninflated

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

Group Type: SHAM_COMPARATOR

BStrong Bands

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Savannah Wooten

UNKNOWN

Sponsor Role: collaborator

Stray-Gundersen, Sten, Ph.D.

INDIV

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Hirofumi Tanaka

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hirofumi Tanaka, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Cardiovascular Aging Research Lab at UT Austin

Austin, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19952840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26246503 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26822582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23738677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23341425 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27633625 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32547424 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-10-0074

Identifier Type: -

Identifier Source: org_study_id