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

Primary Purpose

Quadriceps Atrophy, ACL Reconstruction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction
Physical therapy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quadriceps Atrophy focused on measuring anterior cruciate ligament reconstruction

Eligibility Criteria

14 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical therapy (PT) plus blood flow restriction (BFR)

Physical therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery

Secondary Outcome Measures

Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
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.
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.
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.
Isometric quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Isometric quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Isokinetic quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Balance Error Scoring System
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Balance Error Scoring System
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Initiation of PT is 1 month after surgery.
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.
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.
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.
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Initiation of PT is 1 month after surgery.
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.
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.
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.

Full Information

First Posted
March 23, 2017
Last Updated
May 3, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03096366
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadriceps Atrophy, ACL Reconstruction
Keywords
anterior cruciate ligament reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Blinding is not possible given the nature of the intervention.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical therapy (PT) plus blood flow restriction (BFR)
Arm Type
Experimental
Arm Description
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).
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Blood flow restriction
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 5 months after start of PT
Secondary Outcome Measure Information:
Title
Change in Passive Range of Motion as Assessed by Goniometer
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Passive Range of Motion as Assessed by Goniometer
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Passive Range of Motion as Assessed by Goniometer
Description
Initiation of PT is 1 month after surgery
Time Frame
at start of PT, 5 months after start of PT
Title
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
Description
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.
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
Description
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.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
Description
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.
Time Frame
at start of PT, 5 months after start of PT
Title
Isometric quadriceps strength as Assessed by Dynamometer
Description
Initiation of PT is 1 month after surgery.
Time Frame
1 month after start of PT
Title
Isometric quadriceps strength as Assessed by Dynamometer
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Isokinetic quadriceps strength as Assessed by Dynamometer
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT
Title
Functional Performance as Assessed by Balance Error Scoring System
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Balance Error Scoring System
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Overhead Squat Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Overhead Squat Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Y-Balance Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Y-Balance Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Single-Leg Squat Assessment
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Single-Leg Squat Assessment
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Vail Sport Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Vail Sport Test
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Landing Error Scoring System
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Landing Error Scoring System
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Functional Performance as Assessed by Single leg Hop Testing
Description
Initiation of PT is 1 month after surgery.
Time Frame
2 months after start of PT
Title
Functional Performance as Assessed by Single leg Hop Testing
Description
Initiation of PT is 1 month after surgery.
Time Frame
5 months after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT
Title
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT
Title
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT
Title
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
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 1 month after start of PT
Title
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
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 2 months after start of PT
Title
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
Description
Initiation of PT is 1 month after surgery.
Time Frame
at start of PT, 5 months after start of PT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walter R Lowe, MD
Phone
713-486-6844
Email
walter.r.lowe@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter R Lowe, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter R Lowe, MD
Phone
713-486-6844
Email
walter.r.lowe@uth.tmc.edu

12. IPD Sharing Statement

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

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