NCT06664827

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

Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-16
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2024-10-30
• Last updated: 2025-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study