Quadriceps AtrophyNCT03096366
Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?
A study testing Blood flow restriction and Physical therapy in people with Quadriceps Atrophy and ACL Reconstruction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 55 years
- Conditions the study is for
- Quadriceps Atrophy, ACL Reconstruction
- What is being tested?
- Blood flow restriction and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2017to Dec 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unable to attend (or participate in) physical therapy
- Pregnancy
- Malignancy
- Fracture
- Peripheral vascular disease
- History of deep vein thrombosis (DVT)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Walter R Lowe, MD, 713-486-6844, walter.r.lowe@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Quadriceps Atrophy, ACL Reconstruction
- Being tested
- Blood flow restriction, Physical therapy
- Keywords
- anterior cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionDevice
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy (PT) plus blood flow restriction (BFR) | Experimental | 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). Receives: Device: Blood flow restriction; Other: Physical therapy |
| Physical therapy | Active comparator | 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. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Initiation of PT is 1 month after surgery
Measured: 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
Measured: 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
Measured: at start of PT, 5 months after start of PT
Secondary outcomes (41)
Change in Passive Range of Motion as Assessed by Goniometer
Initiation of PT is 1 month after surgery
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month after start of PT
Isometric quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Isokinetic quadriceps strength as Assessed by Dynamometer
Initiation of PT is 1 month after surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months after start of PT
Functional Performance as Assessed by Balance Error Scoring System
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Initiation of PT is 1 month after surgery.
Measured: 5 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Measured: 2 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Initiation of PT is 1 month after surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at start of PT, 5 months after start of PT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start21 Nov 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Responsible party
- Principal investigator, Walter R Lowe, The University of Texas Health Science Center, Houston
- Investigators
- Walter R Lowe, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096366
- Sponsor's protocol ID
- HSC-MS-16-1047
- Status last verified
- May 2022
- First submitted
- 23 Mar 2017
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03096366
- Acronym / sponsor ID
- HSC-MS-16-1047
- Conditions
- Quadriceps Atrophy, ACL Reconstruction
- Keywords
- anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical therapy (PT) plus blood flow restriction (BFR) | Experimental | Device: Blood flow restriction, Other: Physical therapyPhysical 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 | Active comparator | Other: Physical therapyPhysical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. |
Who may qualify
- Ages
- 14 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Unable to attend (or participate in) physical therapy
- Pregnancy
- Malignancy
- Fracture
- Peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restrictionWith 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 | Physical therapy (PT) plus blood flow restriction (BFR) |
| Physical therapyPhysical 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 (PT) plus blood flow restriction (BFR) |
Primary outcome
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
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
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
41 secondary outcomes
Change in Passive Range of Motion as Assessed by Goniometer
Time frame: 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
Change in Passive Range of Motion as Assessed by Goniometer
Time frame: 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
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
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
Isometric quadriceps strength as Assessed by Dynamometer
Time frame: 1 month after start of PT
Isometric quadriceps strength as Assessed by Dynamometer
Time frame: 2 months after start of PT
Isokinetic quadriceps strength as Assessed by Dynamometer
Time frame: 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
Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape
Time frame: 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
Functional Performance as Assessed by Balance Error Scoring System
Time frame: 2 months after start of PT
Functional Performance as Assessed by Balance Error Scoring System
Time frame: 5 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Time frame: 2 months after start of PT
Functional Performance as Assessed by Overhead Squat Test
Time frame: 5 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Time frame: 2 months after start of PT
Functional Performance as Assessed by Y-Balance Test
Time frame: 5 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Time frame: 2 months after start of PT
Functional Performance as Assessed by Single-Leg Squat Assessment
Time frame: 5 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Time frame: 2 months after start of PT
Functional Performance as Assessed by Vail Sport Test
Time frame: 5 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Time frame: 2 months after start of PT
Functional Performance as Assessed by Landing Error Scoring System
Time frame: 5 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Time frame: 2 months after start of PT
Functional Performance as Assessed by Single leg Hop Testing
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walter R Lowe, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction and Physical therapy in people with Quadriceps Atrophy and ACL Reconstruction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter R Lowe, MD (713-486-6844, walter.r.lowe@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound (time frame: at start of PT, 1 month after start of PT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.