NCT05748821

Brief Summary

The purpose of this study is to investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) blood flow restriction (BFR) bicep curls on indices of arterial stiffness. We are attempting to differentiate physiological changes with AR and NAR bicep curl exercise. Twenty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), AR BFR and NAR BFR) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). After a familiarization session with the BFR device, subjects will perform arm curls during the three treatment sessions with 4 sets to failure with a 2 seconds concentric and 2 seconds eccentric cadence, at 20% 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity, beta-stiffness index, and augmentation index.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

February 8, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Beta-Stiffness Index

    A measurement that compares carotid SBP and DBP with carotid systolic and diastole diameters.

    10 minutes after exercise trial.

  • Carotid-femoral pulse wave velocity

    A measurement that records the time difference between the foot of the systolic wave form as it arrives at the carotid and femoral arterial sites. It is measured with an arterial tonometer.

    15 minutes after exercise trial.

Study Arms (3)

Autoregulated blood flow restriction

ACTIVE COMPARATOR

Autoregulated BFR expands as the muscle progresses into the stretch-shortening cycle.

Device: Delfi Personal Tourniquet Systems

Non-autoregulated blood flow restriction

ACTIVE COMPARATOR

Non-autoregulated BFR does not expand as the muscle progresses into the stretch-shortening cycle.

Device: Delfi Personal Tourniquet Systems

No blood flow restriction

ACTIVE COMPARATOR

This group serves as the control group for this study

Device: Delfi Personal Tourniquet Systems

Interventions

Measure within \& between differences in acute vascular compliance from pre- to post-training with autoregulated BFR, nonautoregulated BFR and no BFR conditions.

Autoregulated blood flow restrictionNo blood flow restrictionNon-autoregulated blood flow restriction

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years old
  • Physically active (\> 6 months of consistent exercise training)
  • Weight stable for previous 6 months (+/-2.5 kg)
  • Female subjects only- reported regular menstrual cycles for the last 2 years

You may not qualify if:

  • BP\>140/90 mmHg
  • BMI\>40 kg/m2
  • Diabetes
  • Familial hypercholesterolemia
  • Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
  • Women must not be pregnant, plan to become pregnant during the study, or be nursing
  • Active renal or liver disease
  • All medications and supplements that influence dependent variables
  • Recent surgery \< 2 months
  • Alcohol abuse
  • Sleep apnea
  • Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21801, United States

RECRUITING

Central Study Contacts

Nick Rolnick, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 1, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 20, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations