RecruitingNot Applicable

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

United States150 participantsStarted 2017-11-21

Plain-language 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.

Who can participate

Age range

14 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 1 month after start of PT

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 2 months after start of PT

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 5 months after start of PT

Trial details

NCT IDNCT03096366

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12

Contact for this trial

Walter R Lowe, MD

713-486-6844 walter.r.lowe@uth.tmc.edu

View on ClinicalTrials.gov More Quadriceps Atrophy trials

Plain-language summary

Who can participate

Age range

14 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 1 month after start of PT

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 2 months after start of PT

Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound

Timeframe: at start of PT, 5 months after start of PT