Clinical trial NCT04635579: Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Official title: Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Tear
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a cross-sectional study on the use of personalized blood flow restriction during rehabilitation exercises and its effects on biomechanics on people who have had an anterior cruciate ligament reconstruction and healthy controls

Detailed description: Rehabilitation after surgical reconstruction of the anterior cruciate ligament (ACL) aims to reestablish the function of the knee. However, regaining previous levels of strength is challenging, with long-term muscle weakness frequently reported and thought to play a key role in the increased risk of knee osteoarthritis for individuals with a history of ACL damage. Effectively building muscle strength requires exercises with high resistance loads, however the joint stress and risk of further injury makes these types of activities inappropriate and unsafe for those rehabilitating after ACL reconstruction surgery and other injuries. Personalized blood flow restriction (BFR) training is a technique where the blood flow to the muscles being exercised is controlled by a pressure cuff to a predefined level, and has been shown to increase strength while exercising with significantly lower loads. Early results have been promising, however the effects of BFR on the biomechanics of the exercise as well as the acceptability in the ACL reconstruction population have not been explored. In this application, we propose a cross-sectional study designed to test the acceptability of BFR training for those undergoing rehabilitation from ACL reconstruction surgery and healthy controls during free standing exercises. We will also investigate the biomechanical effects of this rehabilitation technique. This application is part of a larger program of musculoskeletal research in this area being developed by the team. The results from the proposed project will inform the design of a clinical trial of personalized BFR after ACL reconstruction.

Eligibility criteria: Inclusion Criteria (ACL-R group):

* Must be undergoing rehabilitation for anterior cruciate ligament reconstruction surgery
* Must be at least 3 months post surgery.
* Attending clinician should confirm that they are able to take part in the trial

Exclusion Criteria:

* Any other orthopaedic, neurological, or other condition within the last 12 months that would affect ability to carry out the required exercises
* Any medical conditions that may affect circulation including, but not limited to, deep vein thrombosis, high blood pressure, and cardiac disease

Primary outcomes:
measure: Knee Flexion
timeFrame: 6 minutes
measure: Knee Internal Rotation
timeFrame: 6 minutes
measure: Knee Varus
timeFrame: 6 minutes
measure: Hip Flexion
timeFrame: 6 minutes
measure: Hip Adduction
timeFrame: 6 minutes
measure: Hip Internal Rotation
timeFrame: 6 minutes
measure: Knee Extension Moment
timeFrame: 6 minutes
measure: Knee Internal Rotation Moment
timeFrame: 6 minutes
measure: Knee Adduction Moment
timeFrame: 6 minutes
measure: Hip Extension Moment
timeFrame: 6 minutes
measure: Hip Adduction Moment
timeFrame: 6 minutes
measure: Hip Internal Rotation Moment
timeFrame: 6 minutes
Secondary outcomes:
measure: Exercise Difficulty Score
timeFrame: 6 minutes
measure: Exercise Discomfort Score
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Scott Telfer, EngD
role: PRINCIPAL_INVESTIGATOR
References: