NCT03540147

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

Terminated NA Results posted Last updated 11 March 2021

What this trial tests

NA trial testing Hokanson Cuffs in Exercise Training in 20 participants. Terminated before completion.

Timeline

26 January 2018

Primary endpoint
26 May 2019

26 May 2019

Quick facts

Lead sponsor	University of Texas at Austin
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	20
Start date	26 January 2018
Primary completion	26 May 2019
Estimated completion	26 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Hokanson Cuffs
• BStrong Bands

Conditions studied

• Exercise Training — all drugs for Exercise Training →
• Hemodynamic Response — all drugs for Hemodynamic Response →

Sponsor

University of Texas at Austin

Who can join

Adults 18 to 40, any sex, with Exercise Training or Hemodynamic Response. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Systolic Blood Pressure Primary · Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.

Arterial blood pressure was measured using the automatic oscillometric methods.

Baseline (before the experimental arm participation)

Group	Value	95% CI
Exercise With Hokanson Cuffs	116	± 11
Exercise With BStrong Bands	116	± 9
Exercise Without Inflated Bands/Cuffs	117	± 7
Yoga Poses With BStrong Bands Inflated	117	± 7
Yoga Poses With BStrong Bands Uninflated	115	± 8

Immediately after

Group	Value	95% CI
Exercise With Hokanson Cuffs	150	± 16
Exercise With BStrong Bands	127	± 10
Exercise Without Inflated Bands/Cuffs	158	± 14
Yoga Poses With BStrong Bands Inflated	160	± 15
Yoga Poses With BStrong Bands Uninflated	130	± 15

Flow-mediated Dilation Primary · Before (baseline) and after the exercise interventions

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 bloo

Baseline (before conditions)

Group	Value	95% CI
Exercise With Hokanson Cuffs	7.0	± 2
Exercise With BStrong Bands	7.2	± 2.2
Exercise Without Inflated Bands/Cuffs	7.0	± 1.8
Yoga Poses With BStrong Bands Inflated	6.8	± 1.6
Yoga Poses With BStrong Bands Uninflated	6.9	± 2

After conditions

Group	Value	95% CI
Exercise With Hokanson Cuffs	6.8	± 1.8
Exercise With BStrong Bands	7.1	± 2.0
Exercise Without Inflated Bands/Cuffs	7.1	± 1.9
Yoga Poses With BStrong Bands Inflated	7.0	± 2
Yoga Poses With BStrong Bands Uninflated	6.7	± 1.7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Walking With Leg Blood Flow Restriction: Wide-Rigid Cuffs vs. Narrow-Elastic Bands.
   Stray-Gundersen S, Wooten S, Tanaka H. · · 2020 · cited 16× · PMID 32547424 · DOI 10.3389/fphys.2020.00568