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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT03096366
Status
Recruiting
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Conditions

  • ACL Reconstruction
  • Quadriceps Atrophy

Eligibility Criteria

Sex
ALL
Age
14 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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

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.

Key Dates

Start date
Nov 21, 2017
Status verified
May 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Walter R Lowe, MD
[email protected]
713-486-6844

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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