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Completed

NCT Number: NCT06718582

Effect of Limb Occlusion Pressure Attainment on Cardiovascular, Perceptual, and Performance Responses

To test the effect of limb occlusion pressure attainment in the supine, seated, and standing position on exercise performance, vascular physiology, and muscle.

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Key information

Conditions

Blood Flow Restriction (BFR) Training Effects Arterial Stiffness, Blood Pressure Muscle Morphology Perceptions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salisbury University

Salisbury, Maryland, 21811, United States

About this study

The purpose of this study is to investigate the attainment of limb occlusion pressure (LOP)in the supine, seated, and standing positions on indices of arterial stiffness, muscle morphology, participant perception, and performance responses. Thirty adults aged 18-40 will undergo four treatment sessions (control (no BFR), supine LOP, seated LOP, and standing LOP) 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). All sessions will consist of four sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the LOP with 1-minute rest intervals. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, perceptual responses, and exercise performance.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physically active (> 1,000 MET/min/wk) for at least six months. Weight stable for previous 6 months (+/-2.5 kg) Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion criteria

  • 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

Treatment and study plan

Delfi Training Device

Device

Delfi (Vancouver, Canada) training devices will be used for exercise and testing sessions. Cuffs will be placed around the right and left proximal thigh. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration) following manufacturer specifications. In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. And, in the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. The cuffs will maintain pressure during training and rest periods. The LOP will be reduced to 0% immediately after completing the last set.

Primary outcomes

  1. Arterial Stiffness

    Time frame: From enrollment to the end of treatment at 4 weeks

    Non-invasive pulse tonometers (Complior Analytic Tonometer, Alam Medical, Vincennes, France) will be used to simultaneously obtain arterial pressure waveforms at the carotid, brachial, radial and femoral arteries throughout ten cardiac cycles. Surface distance between the two recording sites will be measured to the nearest 0.5 cm. Subsequently, this process is repeated to measure arterial pressure waveforms at the carotid and radial arteries. Pulse wave velocity for the carotid-femoral (aortic PWV) and carotid-radial (brachial PWV) recordings will be determined by normalizing the waveform foot-to-foot time delay to the distance between recording sites (i.e., PWV = D (cm)/Δt (sec)). The participant will remain supine exactly as they were positioned during the tonometry acquisition sequence. An enlarged caliper will be used to measure the distance between the carotid and radial tonometer, and the distance between the carotid and femoral tonometer.

Secondary outcomes

  1. Muscle Morphology

    Time frame: From enrollment to the end of treatment at 4 weeks

    Participants' muscle cross-sectional area (mCSA) and echo intensity (EI) of the vastus lateralis (VL) muscle will be assessed using a brightness mode (B-mode) of the ultrasound imaging system (Terason t3300, MA, USA) and a multi-frequency linear-array probe (Model 15L4 Smart Mark 4-15 MHz, 50-mm field of view). All ultrasonic scans will be conducted on the participants' right arm to measure the mCSA and EI of the VL. Each participant will be instructed to lay in a supine position with their shoulder abducted at 90 degree and elbow flexed at 90 degrees. The VL measurements will be obtained from their right leg at 50% of the distance between the greater tubercle and lateral epicondyle. Locations of measurements will be marked with indelible ink to ensure scans will be taken at the same area for all scans. During every scan, water soluble gel will be applied on the skin and ultrasound probe to maximize acoustic coupling and reduce near-field artifacts.

Sponsors and collaborators

Lead sponsor

Teri Herberger

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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