Blood Flow Restriction (BFR) Training on the Ulnar Collateral Ligament (UCL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorThe Methodist Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy volunteer
Agree to complete all exercise sessions and program in its entirety
Between the ages of 18-50 years old
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Delfi PTS Blood Flow Restriction Tourniquet System
DeviceIn 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: BFR Training on the UCLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Relative ligament thickness of the UCL
Ligament thickness will be evaluated by ultrasound imaging measurement.
Time frame
From baseline visit to end of treatment at 8 weeks2
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.
Time frame
At baseline visit and end of treatment at 8 weeksSecondary outcomes
1
Changes in arm strength
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.
Time frame
From baseline visit to end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov