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

NCT06718582 | Completed DMC

• 1 other identifier: #430
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

blood flow restriction training; arterial stiffness; rating of perceived effort; traing volume; rating of perceived discomfort

Outcome Measures

Primary Outcomes (1)

• Arterial Stiffness

  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.

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Muscle Morphology

  From enrollment to the end of treatment at 4 weeks

Study Arms (4)

Supine Limb Occlusion Pressure

EXPERIMENTAL

In the supine LOP session, the BFR cuffs will be pressurized to 60% of the supine LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be 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.

Device: Delfi Training Device

Seated Limb Occlusion Pressure

EXPERIMENTAL

In the seated LOP session, the BFR cuffs will be pressurized to 60% of the seated LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be 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.

Device: Delfi Training Device

Standing Limb Occlusion Pressure

EXPERIMENTAL

In the standing LOP session, the BFR cuffs will be pressurized to 60% of the standing LOP. After inflation of the BFR cuffs, four sets of dumbbell wall squats will be 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.

Device: Delfi Training Device

No BFR cuff

PLACEBO COMPARATOR

Four sets of dumbbell wall squats will be 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 with no BFR cuffs

Device: Delfi Training Device

Interventions

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.

No BFR cuff; Seated Limb Occlusion Pressure; Standing Limb Occlusion Pressure; Supine Limb Occlusion Pressure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Teri Herberger: lead

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21811, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Sponsored Research Programs

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: February 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: April 15, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: January 2026 - December 2029

Locations

US (1)