Quantification of Progenitor Cell Circulation Following Vascular Resistance Exercise Using Delfi Tourniquet System

NCT07213726 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-08

No results posted yet for this study

Summary

The purpose of this observational study is to examine how slowing down blood flow to the legs- a practice called blood flow restriction (BFR)- during exercise by applying compression to the legs affects the way stem cells are released into the blood stream. This will be determined by drawing 6 cubic centimeters (ccs) of blood immediately post-exercise after the Delfi Personalized Tourniquet System (PTS) has been removed. 6 ccs of blood will also be taken prior to exercise and at the 20-, 40-, and 60-minute marks after exercise. The main question of this study is:

• Will the levels of stem cells extracted before and after exercise be the same if blood flow is restricted during exercise?

In this study, participants will undergo the following:

* 6 ccs of blood extracted from the forearm prior to exercise to establish a baseline
* 3 exercises- seated leg extension, semi-reclined leg press, and seated hamstring curl- consisting of 4 sets of 30-15-15-15 repetitions per exercise; resistance will be set to 30% of one-rep maximum (1-RM)
* Additional 6 cc blood draws will be performed immediately post-exercise and after 20, 40, and 60 minutes have elapsed

Conditions

  • Blood Flow Restriction (BFR) Training Effects

Interventions

DEVICE

Delfi Personalized Tourniquet System

Bilateral proximal thigh bands that will be applied and inflated to a pressure of 80% of occlusive pressure as determined by the automated tourniquet before exercise. A standard exercise session would not include any blood occlusion.

Sponsors & Collaborators

  • Florida

    collaborator OTHER
  • Andrews Research & Education Foundation

    lead OTHER

Principal Investigators

  • Tyler Opitz, DPT, SCS, CSCS · Physical Therapist

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2023-11-20
Completion
2026-11-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213726 on ClinicalTrials.gov