The Influences of Blood Flow Restriction on Leg Press

NCT ID: NCT07052227

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-15

Brief Summary

This study will investigate the use of different blood flow restriction cuffs during leg press exercise on arterial stiffness, muscle morphology, performance, and participant perception.

Detailed Description

This study aims to investigate the use of Delfi vs. Fitcuffs blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, performance, and participant perception. Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), Delfi BFR, and Fitcuffs 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, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of leg press exercises performed to failure with a 2-second concentric and 2-second eccentric cadence at 20% of their 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 main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, and perceptual response.

Conditions

Delfi Cuff; Fitcuff; Placebo - Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Delfi

Group Type: EXPERIMENTAL

Delfi blood flow restriction cuff

Intervention Type: DEVICE

Leg press exercise with Delfi blood flow restriction cuff

Fitcuff

Group Type: EXPERIMENTAL

Fitcuffs

Intervention Type: DEVICE

Leg press exercise with Fitcuff blood flow restriction cuff

Control

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Leg press exercise with no blood flow restriction cuff

Interventions

Delfi blood flow restriction cuff

Leg press exercise with Delfi blood flow restriction cuff

Intervention Type: DEVICE

Fitcuffs

Leg press exercise with Fitcuff blood flow restriction cuff

Intervention Type: DEVICE

Control

Leg press exercise with no blood flow restriction cuff

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Physically active (> 1,000 MET/min/wk) for at least six months.

2. Weight stable for previous 6 months (+/-2.5 kg)

Exclusion Criteria

1. Stage 2 hypertension (SBP >/= 140 and/or DBP >/= 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. Participants 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salisbury University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Werner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Salisbury University

Salisbury, Maryland, United States

Countries

United States

Central Contacts

Tim Werner, PhD

Role: CONTACT

tjwerner@salisbury.edu

410-548-3526

Facility Contacts

Tim Werner

Role: primary

tjwerner@salisbury.edu

740-434-7720

Other Identifiers

#492

Identifier Type: -

Identifier Source: org_study_id