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

NCT ID: NCT06664827

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2028-11-30

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.

Conditions

Healthy; Healthy Male and Female Subjects; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BFR Training on the UCL

Group Type: EXPERIMENTAL

Delfi PTS Blood Flow Restriction Tourniquet System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert A. Jack

Assistant Professor of Clinical Orthopedic Surgery, Academic Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Haley Goble, MHA

Role: CONTACT

hmgoble@houstonmethodist.org

713-441-3930

Facility Contacts

Haley Goble, MHA

Role: primary

hmgoble@houstonmethodist.org

713-441-3930

Other Identifiers

PRO00038314

Identifier Type: -

Identifier Source: org_study_id