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NCT Number: NCT06664827

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

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.

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Key information

Conditions

Healthy Healthy Male and Female Subjects Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Haley Goble, MHA

CONTACT

[email protected]

713-441-3930

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Relative ligament thickness of the UCL

    Time frame: From baseline visit to end of treatment at 8 weeks

    Ligament thickness will be evaluated by ultrasound imaging measurement.

  2. Changes in the ulnohumeral joint laxity

    Time frame: 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 outcomes

  1. Changes in arm strength

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Goble, MHA

CONTACT

[email protected]

713-441-3930

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Oct 30, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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