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Not yet recruiting NCT07052227

The Influences of Blood Flow Restriction on Leg Press

No phase Interventional Delfi Cuff Fitcuff Placebo - Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Delfi blood flow restriction cuff, Fitcuffs, Control.
Who it may be relevant to
Registry conditions: Delfi Cuff, Fitcuff, Placebo - Control. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Influences of Blood Flow Restriction on Leg Press Perceptual Responses and Performance, and Systemic Arterial Stiffness

Overview

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.

Interventions

  • Device Delfi blood flow restriction cuff
    Leg press exercise with Delfi blood flow restriction cuff
  • Device Fitcuffs
    Leg press exercise with Fitcuff blood flow restriction cuff
  • Other Control
    Leg press exercise with no blood flow restriction cuff

Primary outcome measures

  • Pulse wave velocity [Time frame: 10 minutes before and 10 minutes after the exercise intervention]

Eligibility criteria

Inclusion criteria

  • Physically active (> 1,000 MET/min/wk) for at least six months.
  • Weight stable for previous 6 months (+/-2.5 kg)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Salisbury University — Salisbury

Identifiers

NCT: NCT07052227 · #492

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗