Blood Flow Restriction (BFR) Training on the Ulnar Collateral Ligament (UCL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Delfi PTS Blood Flow Restriction Tourniquet System.
- Who it may be relevant to
- Registry conditions: Healthy, Healthy Male and Female Subjects, Healthy Volunteers. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament
Overview
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.
Interventions
- Device 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 measures
- 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]
Secondary outcome measures (1)
- Changes in arm strength [Time frame: From baseline visit to end of treatment at 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Houston Methodist Hospital — Houston
Identifiers
NCT: NCT06664827 · PRO00038314