NCT03096366 · The University of Texas Health Science Center, Houston
Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Peripheral vascular disease
- History of deep vein thrombosis (DVT)
Where
- Houston, Texas
Collaborators
Memorial Hermann Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2022 · Source of record for eligibility and locations