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

May 3, 2022 updated by: Walter R Lowe, The University of Texas Health Science Center, Houston

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
Initiation of PT is 1 month after surgery
at start of PT, 5 months after start of PT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Passive Range of Motion as Assessed by Goniometer
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: 1 month after start of PT
Initiation of PT is 1 month after surgery.
1 month after start of PT
Isometric quadriceps strength as Assessed by Dynamometer
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Isokinetic quadriceps strength as Assessed by Dynamometer
Time Frame: 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Balance Error Scoring System
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Time Frame: 5 months after start of PT
Initiation of PT is 1 month after surgery.
5 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Time Frame: 2 months after start of PT
Initiation of PT is 1 month after surgery.
2 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Time Frame: 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
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
Time Frame: at start of PT, 1 month after start of PT
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
Time Frame: at start of PT, 2 months after start of PT
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
Time Frame: at start of PT, 5 months after start of PT
Initiation of PT is 1 month after surgery.
at start of PT, 5 months after start of PT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Memorial Hermann Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Walter R Lowe, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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