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NCT Number: NCT03096366

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

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.

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Key information

Conditions

Quadriceps Atrophy ACL Reconstruction

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Walter R Lowe, MD

CONTACT

[email protected]

713-486-6844

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

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

    Initiation of PT is 1 month after surgery

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

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

    Initiation of PT is 1 month after surgery

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

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

    Initiation of PT is 1 month after surgery

Secondary outcomes

  1. Change in Passive Range of Motion as Assessed by Goniometer

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

    Initiation of PT is 1 month after surgery

  2. Change in Passive Range of Motion as Assessed by Goniometer

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

    Initiation of PT is 1 month after surgery

  3. Change in Passive Range of Motion as Assessed by Goniometer

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

    Initiation of PT is 1 month after surgery

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. Isometric quadriceps strength as Assessed by Dynamometer

    Time frame: 1 month after start of PT

    Initiation of PT is 1 month after surgery.

  8. Isometric quadriceps strength as Assessed by Dynamometer

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  9. Isokinetic quadriceps strength as Assessed by Dynamometer

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  10. Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape

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

    Initiation of PT is 1 month after surgery.

  11. Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape

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

    Initiation of PT is 1 month after surgery.

  12. Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape

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

    Initiation of PT is 1 month after surgery.

  13. Functional Performance as Assessed by Balance Error Scoring System

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  14. Functional Performance as Assessed by Balance Error Scoring System

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  15. Functional Performance as Assessed by Overhead Squat Test

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  16. Functional Performance as Assessed by Overhead Squat Test

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  17. Functional Performance as Assessed by Y-Balance Test

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  18. Functional Performance as Assessed by Y-Balance Test

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  19. Functional Performance as Assessed by Single-Leg Squat Assessment

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  20. Functional Performance as Assessed by Single-Leg Squat Assessment

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  21. Functional Performance as Assessed by Vail Sport Test

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  22. Functional Performance as Assessed by Vail Sport Test

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  23. Functional Performance as Assessed by Landing Error Scoring System

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  24. Functional Performance as Assessed by Landing Error Scoring System

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  25. Functional Performance as Assessed by Single leg Hop Testing

    Time frame: 2 months after start of PT

    Initiation of PT is 1 month after surgery.

  26. Functional Performance as Assessed by Single leg Hop Testing

    Time frame: 5 months after start of PT

    Initiation of PT is 1 month after surgery.

  27. Change in Activity as Assessed by Patient-Reported Score on the Marx Scale

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

    Initiation of PT is 1 month after surgery.

  28. Change in Activity as Assessed by Patient-Reported Score on the Marx Scale

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

    Initiation of PT is 1 month after surgery.

  29. Change in Activity as Assessed by Patient-Reported Score on the Marx Scale

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

    Initiation of PT is 1 month after surgery.

  30. Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale

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

    Initiation of PT is 1 month after surgery.

  31. Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale

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

    Initiation of PT is 1 month after surgery.

  32. Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale

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

    Initiation of PT is 1 month after surgery.

  33. Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form

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

    Initiation of PT is 1 month after surgery.

  34. Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form

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

    Initiation of PT is 1 month after surgery.

  35. Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form

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

    Initiation of PT is 1 month after surgery.

  36. Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia

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

    Initiation of PT is 1 month after surgery.

  37. Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia

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

    Initiation of PT is 1 month after surgery.

  38. Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia

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

    Initiation of PT is 1 month after surgery.

  39. Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale

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

    Initiation of PT is 1 month after surgery.

  40. Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale

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

    Initiation of PT is 1 month after surgery.

  41. Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale

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

    Initiation of PT is 1 month after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Walter R Lowe, MD

CONTACT

[email protected]

713-486-6844

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Memorial Hermann Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2017
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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