Recruiting

BFR Training

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT06664827

Conditions

Healthy

Healthy Male and Female Subjects

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Delfi PTS Blood Flow Restriction Tourniquet System

Study Details

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 ID

NCT06664827

Start date

Jan 16, 2025

Status verified date

Jan, 2025

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: BFR Training on the UCL

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.

Primary outcome measure

  • Relative ligament thickness of the UCL [ Time Frame: From baseline visit to end of treatment at 8 weeks ]
  • Changes in the ulnohumeral joint laxity [ Time Frame: At baseline visit and end of treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Haley Goble, MHA

713-441-3930hmgoble@houstonmethodist.org

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jan 22, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2025-01-22.