Blood Flow Restriction Following ACLR

NCT04086030 | Withdrawn

• 1 other identifier: 19050802
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the the ability of BFR to reduce muscle loss and improve strength after ACL reconstruction. It is hypothesized that BFR training will significantly reduce muscle loss and improve strength after ACL reconstruction. It is also hypothesized that BFR will result in improved patient reported outcomes and rates of return to sport.

Conditions

Anterior Cruciate Ligament Injuries; ACL; Physical Therapy

Outcome Measures

Primary Outcomes (6)

• Muscle strength

  Quadriceps strength measured with dynamometer

  3 month follow-up

• Muscle strength

  Quadriceps strength measured with dynamometer

  6 month follow-up

• Muscle strength

  Quadriceps strength measured with dynamometer

  12 month follow-up

• Quadriceps hypertrophy

  Standardized circumferential leg measurements to assess quadriceps hypertrophy

  3 month follow-up

• Quadriceps hypertrophy

  Standardized circumferential leg measurements to assess quadriceps hypertrophy

  6 month follow-up

• Quadriceps hypertrophy

  Standardized circumferential leg measurements to assess quadriceps hypertrophy

  12 month follow-up

Study Arms (2)

Sham Postoperative Rehabilitation

SHAM COMPARATOR

Patients in this group will complete the standardized postoperative rehabilitation program with sham BFR, which is pressure of 20 mmHG. Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set. The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise.

Other: Sham Blood Flow Restriction Training

BFR Postoperative Rehabilitation

EXPERIMENTAL

Assigned intervention of BFR where exercises are performed with BFR at 80% limb occlusion pressure (LOP). Patients in this group will undergo blood flow restriction (BFR) training during their postoperative rehabilitation program (use an inflatable cuff that prevents blood flow from flowing out of the leg while patients perform physical therapy exercises). Exercises will be performed for 4 sets of 30/15/15/15 repetitions with a 30 second rest period between each set.16 The tourniquet cuff will remain inflated for all sets and rest periods for the selected exercise. A cadence of 2-second concentric and 2- second eccentric contractions (4 second time under tension) will be maintained for each BFR repetition. Upon completion of the exercise, the tourniquet cuff will be deflated, and a 1 minute minimum rest period will occur before moving on to another BFR exercise.

Other: Blood Flow Restriction Training

Interventions

Blood Flow Restriction Training OTHER

Patients will undergo standardized postoperative rehabilitation program including blood flow restriction training. Exercises will be performed with BFR at 80% LOP.

BFR Postoperative Rehabilitation

Sham Blood Flow Restriction Training OTHER

Patients will undergo standardized postoperative rehabilitation program where exercises will be performed with sham BFR pressure of 20 mmHG.

Sham Postoperative Rehabilitation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients 18-40
• English-speaking
• Primary ACL Reconstruction
• No associated procedures (meniscal repair, other ligamentous pathology), or history of deep vein thrombosis.
• Clinical and radiographic examination (MRI) consistent with an acute full thickness ACL tear and surgical consent for ACL reconstruction with a patellar tendon autograft
• Written and informed consent for study participation

You may not qualify if:

• Patients younger than 18 or older than 40 years of age
• Non-native English speaker
• Revision surgery or prior history of knee surgery
• Concomitant ligamentous, meniscal, or cartilage injury that would alter postoperative weight bearing status or rehabilitation protocol
• Inability to comply with the proposed follow-up clinic visits
• Patients lacking decisional capacity
• Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state
• Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
• Worker's compensation patients
• Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
• Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 11, 2019
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08