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Recruiting NCT03096366

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

No phase Interventional Quadriceps Atrophy ACL Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood flow restriction, Physical therapy.
Who it may be relevant to
Registry conditions: Quadriceps Atrophy, ACL Reconstruction. Basic parameters: 14 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery? A Randomized Clinical Trial

Overview

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]
  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT03096366 · HSC-MS-16-1047

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗