Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?

Study Overview
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Brief Summary
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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.

Official Title
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Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial

Conditions
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Quadriceps Atrophy, ACL Reconstruction

Intervention / Treatment
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* Device: Blood flow restriction
* Other: Physical therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical therapy (PT) plus blood flow restriction (BFR)<br>Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg). | Device: Blood flow restriction<br>* With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg).<br>Other: Physical therapy<br>* Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.<br>|
| Active Comparator: Physical therapy<br>Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. | Other: Physical therapy<br>* Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT | 
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 2 months after start of PT | 
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT | 
| Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 2 months after start of PT | 
| Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT | 
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb. Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 1 month after start of PT | 
| Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Isokinetic quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 2 months after start of PT | 
| Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 5 months after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 
| 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 | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT | 
| 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 | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT | 
| 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 | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament reconstruction