Blood Flow Restriction Therapy for Distal Radius Fracture

(ORIF DR BFR Trial)

Overseen By Roxanne Miller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Ergogenic aids

Disqualifiers: Obesity, Diabetes, Cardiovascular, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery. Therefore, the specific aims of this study are as follows: 1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone. 2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone. 3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking any ergogenic aids (substances that enhance physical performance) or compounds banned by the NCAA, you must stop them at least one month before participating.

Is Blood Flow Restriction (BFR) Therapy safe for humans?

Blood Flow Restriction (BFR) Therapy is generally safe and well tolerated in humans, as shown in studies where it was used for rehabilitation after distal radius fractures without any noted complications. ^{1 2 3 4 5}

How does blood flow restriction therapy differ from other treatments for distal radius fracture?

Blood flow restriction therapy is unique because it involves applying a tight band or cuff to restrict blood flow to the injured area, which can help improve muscle strength and recovery without the need for heavy weights. This method is different from traditional treatments that may rely more on immobilization or surgery. ^{6 7 8 9 10}

Research Team

Shari Liberman, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for adults over 18 who need surgery (ORIF) for a broken wrist at the end of the forearm bone. It's not suitable for those with severe pain, previous injuries or surgeries to that arm, extreme obesity, diabetes type II, major organ diseases, active infections, recent cancer history, bleeding disorders, significant weight changes in the last year, inability to do rehab exercises or those on certain medications.

Inclusion Criteria

I am 18 years old or older.

I need surgery for a broken wrist bone.

Exclusion Criteria

I have Type II diabetes.

I have heart, kidney, liver, or lung disease.

I do not have any active infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Initial Recovery

Participants undergo ORIF surgery for distal radius fractures and initial recovery

2 weeks

1 visit (in-person)

Rehabilitation with Blood Flow Restriction

Participants begin physical therapy with BFR exercises at two weeks post-operatively

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 2 months, 6 months, and 1 year post-op

Treatment Details

Interventions

• Blood Flow Restriction (BFR) Therapy

Trial Overview The study tests if adding Blood Flow Restriction (BFR) therapy to standard post-surgery rehab can better prevent muscle loss and improve strength and recovery after wrist fracture surgery. Participants will undergo low intensity resistance exercise with BFR cuff as part of their rehabilitation routine.

Participant Groups

Group I: Intervention - Blood Flow Restriction Therapy (BFR) Experimental Treatment 1 Intervention

Subjects will undergo standard postoperative rehabilitation that incorporates BFR during certain exercises.

Group II: Control Active Control 1 Intervention

Standard of care postoperative rehabilitation. Subject will undergo standard rehab following surgery without BFR.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Blood Flow Restriction Therapy after Operative Management of Distal Radius Fractures: A Randomized Controlled Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness and safety of blood flow restriction training for the post-operation treatment of distal radius fracture. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

BFR Training Improves Patients' Reported Outcomes, Strength, and Range of Motion After Casting for Colles' Fracture. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Forecasting effects of "fast-tracks" for surgery in the Swedish national guidelines for distal radius fractures. [2023]

5. France pubmed.ncbi.nlm.nih.gov

Minimally invasive anterior plate osteosynthesis of the distal radius: A 710 case-series. [2021]

6. Japan pubmed.ncbi.nlm.nih.gov

Front-line fludarabine-cyclophosphamide-rituximab (FCR) in 110 patients with chronic lymphocytic leukaemia (CLL): real-life experience with long-term outcomes, toxicities and responses to second-line therapies. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Treatment of Intracranial Aneurysms with Flow Re-direction Endoluminal Device - A Single Centre Experience with Short-term Follow-up Results. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Reduced-dose fludarabine, cyclophosphamide, and rituximab (FCR-Lite) plus lenalidomide, followed by lenalidomide consolidation/maintenance, in previously untreated chronic lymphocytic leukemia. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Enhancing the action of rituximab in chronic lymphocytic leukemia by adding fresh frozen plasma: complement/rituximab interactions & clinical results in refractory CLL. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapsed/refractory follicular lymphoma: a Fondazione Italiana Linfomi multicenter, randomized, phase III trial. [2023]