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

NCT06664827 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2026-11-30
Completion
2028-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664827 on ClinicalTrials.gov