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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-55
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to attend (or participate in) physical therapy

Pregnancy

Malignancy

Fracture

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood flow restriction

    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

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Physical therapy (PT) plus blood flow restriction (BFR)Experimental treatment 2 interventions
Group B: Physical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 1 month after start of PT
2

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

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 2 months after start of PT
3

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

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 5 months after start of PT

Secondary outcomes

1

Change in Passive Range of Motion as Assessed by Goniometer

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 1 month after start of PT
2

Change in Passive Range of Motion as Assessed by Goniometer

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 2 months after start of PT
3

Change in Passive Range of Motion as Assessed by Goniometer

Initiation of PT is 1 month after surgery

Time frame
at start of PT, 5 months after start of PT
4

Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test

The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb. Initiation of PT is 1 month after surgery.

Time frame
at start of PT, 1 month after start of PT

Other outcomes

Sponsors and contacts

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