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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ACL Reconstruction; Quadriceps Atrophy
• Intervention / Treatment: Device: Blood flow restriction; Other: Physical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Walter R Lowe, MD; Phone Number: 713-486-6844; Email: walter.r.lowe@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Walter R Lowe, MD; Phone Number: 713-486-6844; Email: walter.r.lowe@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical therapy (PT) plus blood flow restriction (BFR); 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; 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).; Other: Physical therapy; 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.
Active Comparator: Physical therapy; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Memorial Hermann Hospital
• Investigators: Principal Investigator: Walter R Lowe, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: anterior cruciate ligament reconstruction
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: HSC-MS-16-1047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes