HealthyNCT06664827
Blood Flow Restriction (BFR) Training on the Ulnar Collateral Ligament (UCL)
A study testing Delfi PTS Blood Flow Restriction Tourniquet System in people with Healthy and Healthy Male and Female Subjects, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Male and Female Subjects, Healthy Volunteers
- What is being tested?
- Delfi PTS Blood Flow Restriction Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
- Agree to complete all exercise sessions and program in its entirety
- Between the ages of 18-50 years old
Who cannot join
- 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
Show all 9Show fewer
- Any musculoskeletal conditions resulting in inability to exercise
- Participants may not be collegiate/professional baseball/softball players
- Vulnerable populations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Haley Goble, MHA, 713-441-3930, hmgoble@houstonmethodist.org
About this study
Official title: Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament
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:
- Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space?
- Are there changes in arm strength following the 8-week strengthening protocol with/without BFR?
Read more
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.
- Being tested
- Delfi PTS Blood Flow Restriction Tourniquet System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfi PTS Blood Flow Restriction Tourniquet SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR Training on the UCL | Experimental | Not described Receives: Device: Delfi PTS Blood Flow Restriction Tourniquet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative ligament thickness of the UCL
Ligament thickness will be evaluated by ultrasound imaging measurement.
Measured: From baseline visit to end of treatment at 8 weeks
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.
Measured: At baseline visit and end of treatment at 8 weeks
Secondary 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.
Measured: From baseline visit to end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start16 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert A. Jack, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664827
- Sponsor's protocol ID
- PRO00038314
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament
- ClinicalTrials.gov ID
- NCT06664827
- Acronym / sponsor ID
- PRO00038314
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BFR Training on the UCL | Experimental | Device: Delfi PTS Blood Flow Restriction Tourniquet System |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteer
- Agree to complete all exercise sessions and program in its entirety
- Between the ages of 18-50 years old
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delfi PTS Blood Flow Restriction Tourniquet SystemIn 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. | Device | BFR Training on the UCL |
Primary outcome
Relative ligament thickness of the UCL
Time frame: From baseline visit to end of treatment at 8 weeks
Ligament thickness will be evaluated by ultrasound imaging measurement.
Changes in the ulnohumeral joint laxity
Time frame: At baseline visit and end of treatment at 8 weeks
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.
1 secondary outcome
Changes in arm strength
Time frame: From baseline visit to end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delfi PTS Blood Flow Restriction Tourniquet System in people with Healthy and Healthy Male and Female Subjects, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Goble, MHA (713-441-3930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative ligament thickness of the UCL (time frame: From baseline visit to end of treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.