Recruiting

Blood Flow Restriction Training

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT03096366

Conditions

Quadriceps Atrophy

ACL Reconstruction

Eligibility Criteria

Sex: All

Age: 14 - 55

Healthy Volunteers: Not accepted

Interventions

Blood flow restriction

Physical therapy

Study Details

Brief 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.

Conditions

Quadriceps Atrophy

ACL Reconstruction

Study ID

NCT03096366

Start date

Nov 21, 2017

Status verified date

May, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

Interventions

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).

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 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 ]
  • Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Walter R Lowe, MD

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Walter R Lowe, MD

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 4, 2022

Last verified

May, 2022

Keywords

  • anterior cruciate ligament reconstruction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-05-04.