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

Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Healthy Volunteers; Healthy Male and Female Subjects
• Intervention / Treatment: Device: Delfi PTS Blood Flow Restriction Tourniquet System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Contact: Haley Goble, MHA; Phone Number: 713-441-3930; Email: hmgoble@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BFR Training on the UCL

Device: Delfi PTS Blood Flow Restriction Tourniquet System; In Houston Methodist rehabilitation clinics these devices are used as standard of care for BFR therapy in many post-operative treatments. General guidelines suggest using ranges between 30% - 80% of limb occlusion pressure (LOP). In our previous research efforts involving BFR the investigators have adhered to these guidelines and experienced no adverse events while observing these ranges to be well tolerated by subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative ligament thickness of the UCL	Ligament thickness will be evaluated by ultrasound imaging measurement.	From baseline visit to end of treatment at 8 weeks
Changes in the ulnohumeral joint laxity	Any changes will be evaluated by ultrasound imaging. To calculate the relative measurement, also known as the side-to-side difference (STS), investigators will take measurements from both the dominant and nondominant arms and then calculate difference between the two.	At baseline visit and end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in arm strength	This value will be measured with a crane scale (a device used to measure force) and will evaluate the participant's maximum force output with different movements. Higher or lower scores don't reflect whether an outcome is better or worse, but rather each participant's scores are only being compared to their own to assess strength change.	From baseline visit to end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PRO00038314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No