Blood Flow Restriction Following ACL Reconstruction (BFR)

Inova Health Care Services

Status: Completed

Conditions: Anterior Cruciate Ligament Rupture

Treatments: Device: Blood Flow Restriction Therapy; Other: ACL Reconstruction rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03758755

18-3150

Details and patient eligibility

About

The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.

Full description

Recovery from anterior cruciate ligament (ACL) reconstruction involves early physical therapy to promote muscular development. Traditional training regimens are based on the concept that muscle growth is induced with high resistance exercises of at least 65-70% of 1-repetition maximum. Achieving a high resistance level can be challenging in the early post-surgical patient who may be limited by pain, muscle atrophy, diminished proprioception, and psychological factors. Increasing evidence has suggested that Blood Flow Restriction (BFR) in resistance training, while transmitting a decreased load (25-50% of 1-repetition maximum) across the surgical site, may provide an additional benefit of inducing muscular development similar to that of high intensity exercises .

Augmenting exercises with BFR involves an external pressure cuff applied to the proximal portion of the extremity, which is inflated to a pressure that restricts venous outflow while allowing arterial inflow to continue. This creates a physiologic environment for the patient to gain the hypertrophic effect of high resistance training, though at a lower and safer intensity. Studies suggest that BFR stimulates muscular development through an increase in metabolic stress, muscle fiber recruitment, cell swelling, and protein synthesis.

Enrollment: 49 patients

Sex: All

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 13-35 years at the time of surgery
2. Anterior Cruciate Ligament (ACL) reconstruction
3. Using a physical therapy center with Blood Flow Restriction capabilities.

Exclusion criteria

1. Concomitant ligament reconstruction
2. Concurrent procedures that require delayed weight bearing (ie: High Tibial Osteotomy (HTO), multi-ligament reconstruction, microfracture, etc)
3. History of Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
4. Immunocompromising conditions (ie: Rheumatoid arthritis, chronic steroid use, etc.)
5. History of coagulation disorders or current use of anticoagulants
6. Completion of physical therapy at a location not affiliated with the study
7. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

BFR Therapy

Experimental group

Description:

This group will undergo physical therapy exercises per the standard of care, with the addition of Blood Flow Restriction (BFR) utilizing a wide pressure cuff. BFR exercises will be initiated two weeks post-op, and continued for 16 weeks.

Treatment:

Device: Blood Flow Restriction Therapy

Other: ACL Reconstruction rehabilitation

No BFR

Active Comparator group

Description:

This group of patients will undergo physical therapy exercises per the current standard of care after their ACL reconstruction without BFR

Treatment:

Other: ACL Reconstruction rehabilitation