Recruiting

Blood Flow Restriction

Sponsor:

Salisbury University

Code:

NCT05748821

Conditions

Arterial Stiffness

Healthy Lifestyle

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Delfi Personal Tourniquet Systems

Study Details

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.

Conditions

Arterial Stiffness

Healthy Lifestyle

Study ID

NCT05748821

Start date

Apr 1, 2023

Status verified date

Jul, 2023

Completion date

Dec 20, 2023

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. BP>140/90 mmHg
2. BMI>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. 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.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables
9. Recent surgery < 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Autoregulated blood flow restriction

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

active comparator: Non-autoregulated blood flow restriction

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

active comparator: No blood flow restriction

This group serves as the control group for this study

Interventions

Delfi Personal Tourniquet Systems

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

Primary outcome measure

  • Beta-Stiffness Index [ Time Frame: 10 minutes after exercise trial. ]
  • Carotid-femoral pulse wave velocity [ Time Frame: 15 minutes after exercise trial. ]

Central Contacts and Locations

Central contacts

Locations

Salisbury University

Recruiting

Salisbury, Maryland, United States, 21801

Contacts

More Information

Sponsor

Salisbury University

Last update posted

Jul 27, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salisbury University on 2023-07-27.