Trial Outcomes & Findings for The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses (NCT NCT03540147)

Results Overview

Arterial blood pressure was measured using the automatic oscillometric methods.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.

Results posted on

2021-03-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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".
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Blood Flow Restriction Exercise n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	23 year STANDARD_DEVIATION 4 • n=20 Participants
Sex: Female, Male Female	10 Participants n=20 Participants
Sex: Female, Male Male	10 Participants n=20 Participants
Body weight	71 kg STANDARD_DEVIATION 10 • n=20 Participants

PRIMARY outcome

Timeframe: Measurements were taken at Baseline (before Experimental Arm Participation) and immediately after Experimental Arm Participation.

Population: Baseline (before Experimental Arm Participation) data are reported below.

Arterial blood pressure was measured using the automatic oscillometric methods.

Outcome measures

Outcome measures
Measure	Exercise With Hokanson Cuffs n=20 Participants 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.	Exercise With BStrong Bands n=20 Participants 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.	Exercise Without Inflated Bands/Cuffs n=20 Participants 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.	Yoga Poses With BStrong Bands Inflated n=20 Participants 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.	Yoga Poses With BStrong Bands Uninflated n=20 Participants 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.
Systolic Blood Pressure Baseline (before the experimental arm participation)	116 mmHg Standard Deviation 11	116 mmHg Standard Deviation 9	117 mmHg Standard Deviation 7	117 mmHg Standard Deviation 7	115 mmHg Standard Deviation 8
Systolic Blood Pressure Immediately after	150 mmHg Standard Deviation 16	127 mmHg Standard Deviation 10	158 mmHg Standard Deviation 14	160 mmHg Standard Deviation 15	130 mmHg Standard Deviation 15

PRIMARY outcome

Timeframe: 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 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.