Clinical trial NCT03096366: Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?
Official title: Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quadriceps Atrophy
ACL Reconstruction
Keywords: anterior cruciate ligament reconstruction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
First posted: 2017-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.


Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament (ACL) reconstruction with concomitant meniscus or cartilage restoration procedures
* Adherence to modified weight bearing status before initiation of PT
* Expected participation in recreational or competitive sports after release to full activities

Exclusion Criteria:

* Unable to attend (or participate in) physical therapy
* Pregnancy
* Malignancy
* Fracture
* Peripheral vascular disease
* History of deep vein thrombosis (DVT)

Primary outcomes:
measure: Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
timeFrame: at start of PT, 5 months after start of PT
Secondary outcomes:
measure: Change in Passive Range of Motion as Assessed by Goniometer
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Passive Range of Motion as Assessed by Goniometer
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Passive Range of Motion as Assessed by Goniometer
timeFrame: at start of PT, 5 months after start of PT
measure: Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
timeFrame: at start of PT, 5 months after start of PT
measure: Isometric quadriceps strength as Assessed by Dynamometer
timeFrame: 1 month after start of PT
measure: Isometric quadriceps strength as Assessed by Dynamometer
timeFrame: 2 months after start of PT
measure: Isokinetic quadriceps strength as Assessed by Dynamometer
timeFrame: 5 months after start of PT
measure: Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
timeFrame: at start of PT, 5 months after start of PT
measure: Functional Performance as Assessed by Balance Error Scoring System
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Balance Error Scoring System
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Overhead Squat Test
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Overhead Squat Test
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Y-Balance Test
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Y-Balance Test
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Single-Leg Squat Assessment
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Single-Leg Squat Assessment
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Vail Sport Test
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Vail Sport Test
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Landing Error Scoring System
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Landing Error Scoring System
timeFrame: 5 months after start of PT
measure: Functional Performance as Assessed by Single leg Hop Testing
timeFrame: 2 months after start of PT
measure: Functional Performance as Assessed by Single leg Hop Testing
timeFrame: 5 months after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
timeFrame: at start of PT, 5 months after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
timeFrame: at start of PT, 5 months after start of PT
measure: Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
timeFrame: at start of PT, 5 months after start of PT
measure: Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
timeFrame: at start of PT, 1 month after start of PT
measure: Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
timeFrame: at start of PT, 5 months after start of PT
measure: Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
timeFrame: at start of PT, 1 month after start of PT
measure: Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
timeFrame: at start of PT, 2 months after start of PT
measure: Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale
timeFrame: at start of PT, 5 months after start of PT
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Walter R Lowe, MD
role: PRINCIPAL_INVESTIGATOR
References: