NCT03758755

Blood Flow Restriction Following ACL Reconstruction

The Effect of Blood Flow Restriction Therapy Following Anterior Cruciate Ligament Reconstruction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 13 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	Blood Flow Restriction Therapy	A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
OTHER	ACL Reconstruction rehabilitation	post-operative rehabilitation according to current standards of care

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-11-01
• Completion: 2022-10-26
• First posted: 2018-11-29
• Last updated: 2022-12-22
• Results posted: 2022-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study