What this study is
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.
What's being tested
- Blood flow restriction
Intervention · DEVICE
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
Intervention · OTHER
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 details
- Official title
- Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Quadriceps Atrophy · ACL Reconstruction
- Enrolling
- 150 people
- Starts
- 2017-11-21
- Est. completion
- 2022-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 14 Years – 55 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Unable to attend (or participate in) physical therapy
- Pregnancy
- Malignancy
- Fracture
- Peripheral vascular disease
- History of deep vein thrombosis (DVT)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas Health Science Center at Houston
Houston, Texas, United States
- Walter R Lowe, MD · Contact713-486-6844walter.r.lowe@uth.tmc.edu
Recruiting
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-16-1047
Principal investigator
Walter R Lowe, MD
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.