The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction

NCT ID: NCT06342063

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-01-31

Brief Summary

This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.

Detailed Description

Quadriceps femoris (QF) muscle function is an integral factor in the rehabilitation and overall outcome after lower extremity injury or surgical intervention. Atrophy of this muscle group is a common finding in patients undergoing anterior cruciate ligament (ACL) reconstruction. This is due to the immobility prior to surgery, vascular ischemia caused by a tourniquet intra-operatively and inability to perform high load strength training in the early post-operative period. A deficit in QF muscle strength can result in excessive joint loading and be a contributing factor in the early onset of osteoarthritis of the knee. It should be noted that a loss of strength in this primary knee extensor mechanism muscle group can persist for up to 2 years after surgery. Thus, the reduction of QF atrophy and maintenance of strength during an intervention such as an ACL reconstruction has large implications for the overall post-operative outcome and natural history of the knee joint.

In order to combat the challenges of muscle atrophy for patients with an ACL injury, blood flow restriction (BFR) training has been shown to have beneficial effects in the post-operative period specifically. The process of using BFR therapy involves the application of an extremity tourniquet to occlude venous outflow and restrict arterial inflow. Thus, an anaerobic environment is created to promote muscle hypertrophy by having cells upregulate cell signalling, protein synthesis and ultimately myogenic proliferation. The use of BFR during lower extremity rehabilitation has shown that its simultaneous use with low load resistance training can have similar hypertrophic effects to isolated high load resistance training. This is ideal for patients who are initially unable to perform high intensity exercises shortly after an ACL reconstruction surgery, but are attempting to reduce overall QF atrophy.

However, the use of BFR in the pre-operative period has yet to be well established. Preconditioning with an ischemic environment may provide an effective way to reduce QF atrophy with low load exercises while awaiting surgery. Additionally, having a period of sensitization with anaerobic conditions prior to surgery, may provide some resistance to the damaging effects of a tourniquet intra-operatively. The limited studies that have attempted to use BFR therapy prior to ACL surgery have had short intervention periods, small sample sizes and outcome variables that have not assessed overall clinical outcome. If BFR in the pre-operative setting can be shown to provide beneficial effects, it will be a valuable tool in maximizing the overall outcome of patients undergoing ACL reconstruction.

This prospective feasibility study has been designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial.

Conditions

ACL Injury; Sports Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physiotherapy with Blood Flow Restriction Group

This group underwent a physiotherapy protocol while using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction.

Group Type: ACTIVE_COMPARATOR

Blood Flow Restriction Therapy

Intervention Type: DEVICE

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is inflated.

Physiotherapy without Blood Flow Restriction Group

This group underwent a physiotherapy protocol without using Blood Flow Restriction adjunctive therapy prior to ACL reconstruction.

Group Type: SHAM_COMPARATOR

Blood Flow Restriction Therapy Sham

Intervention Type: DEVICE

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is not inflated.

Interventions

Blood Flow Restriction Therapy

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is inflated.

Intervention Type: DEVICE

Blood Flow Restriction Therapy Sham

Patients wear a personalized tourniquet pressure system on their involved thigh while they perform a series of leg press machine exercises. This tourniquet is not inflated.

Intervention Type: DEVICE

Other Intervention Names

BFR; Sham BFR Comparison Group

Eligibility Criteria

Inclusion Criteria

• Sagittal Knee instability caused by ACL tear requiring surgical reconstruction
• Minimum 4 weeks since the time of injury
• Age 18 to 50 years

• Range of motion required

▪ Active extension deficit <5o, Active flexion > 120o

• No previous surgery to affected knee

Exclusion Criteria

• Functional impairment (neuro disease, gait abnormality, ambulatory aids at baseline)
• Severe spine or lower limb injuries
• Comorbidities including cardiovascular, respiratory or metabolic disease, blood coagulation disorders, current smoker

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Theodoropoulos, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Dovigi Sports Medicine Clinic, Mount Sinai Hospital, Toronto, Canada

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Wengle L, Migliorini F, Leroux T, Chahal J, Theodoropoulos J, Betsch M. The Effects of Blood Flow Restriction in Patients Undergoing Knee Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Aug;50(10):2824-2833. doi: 10.1177/03635465211027296. Epub 2021 Aug 18.

Reference Type: BACKGROUND

PMID: 34406084 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-0070-E

Identifier Type: -

Identifier Source: org_study_id