Blood Flow Restriction (BFR) Training on the Ulnar Collateral Ligament (UCL)

The Methodist Hospital Research Institute (TMHRI)

Status: Enrolling

Conditions: Healthy Volunteers; Healthy; Healthy Male and Female Subjects

Treatments: Device: Delfi PTS Blood Flow Restriction Tourniquet System

Study type: Interventional

Funder types: Other

Identifiers

NCT06664827

PRO00038314

Details and patient eligibility

About

The goal of this clinical trial is to identify any differences in elbow ulnar collateral ligament (UCL) relative thickness and joint space laxity in the dominant arm following an 8-week course of low intensity resistance exercises with blood flow restriction (BFR) exercises in healthy volunteers. The main questions it aims to answer are:

1. Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space?
2. Are there changes in arm strength following the 8-week strengthening protocol with/without BFR?

Participants will:

• Complete two BFR sessions a week for a total of eight weeks.
• Complete an exercise session with both arms (dominant arm will receive BFR) at each study visit.
• Have sonographs taken of the UCL at the first and last study visit.
• Complete strength assessments at the first and last study visit.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer
• Agree to complete all exercise sessions and program in its entirety
• Between the ages of 18-50 years old

Exclusion criteria

• Current or recent injury of the hand, elbow, or shoulder
• Outside of the ages of 18-50 years old
• Vascular compromise or previous vascular surgery
• History of DVT
• Current participation in other BFR research study
• Currently participating in a structured strength training program
• Any musculoskeletal conditions resulting in inability to exercise
• Participants may not be collegiate/professional baseball/softball players
• Vulnerable populations

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

BFR Training on the UCL

Experimental group

Treatment:

Device: Delfi PTS Blood Flow Restriction Tourniquet System