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

NCT06664827 | Recruiting FDA Device

• 1 other identifier: PRO00038314
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Healthy; Healthy Male and Female Subjects; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in arm strength

  From baseline visit to end of treatment at 8 weeks

Study Arms (1)

BFR Training on the UCL

EXPERIMENTAL

Device: Delfi PTS Blood Flow Restriction Tourniquet System

Interventions

Delfi PTS Blood Flow Restriction Tourniquet System DEVICE

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.

BFR Training on the UCL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Central Study Contacts

Haley Goble, MHA

CONTACT

713-441-3930; hmgoble@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Orthopedic Surgery, Academic Institute

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 30, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)