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

Not Applicable

Recruiting

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

• Registration Number: NCT06664827
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-30
• Status Verified: 2025-01
• Study Start: 2025-01-16
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Relative ligament thickness of the UCL	From baseline visit to end of treatment at 8 weeks	Ligament thickness will be evaluated by ultrasound imaging measurement.
Changes in the ulnohumeral joint laxity	At baseline visit and end of treatment at 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Changes in arm strength	From baseline visit to end of treatment at 8 weeks	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.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States