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

ACL Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096366
• Other study ID #: HSC-MS-16-1047
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Walter R Lowe, MD
• Phone: 713-486-6844
• Email: walter.r.lowe[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• ACL Reconstruction
• Atrophy
• Quadriceps Atrophy

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Memorial Hermann Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound	Initiation of PT is 1 month after surgery	at start of PT, 1 month after start of PT
Primary	Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound	Initiation of PT is 1 month after surgery	at start of PT, 2 months after start of PT
Primary	Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound	Initiation of PT is 1 month after surgery	at start of PT, 5 months after start of PT
Secondary	Change in Passive Range of Motion as Assessed by Goniometer	Initiation of PT is 1 month after surgery	at start of PT, 1 month after start of PT
Secondary	Change in Passive Range of Motion as Assessed by Goniometer	Initiation of PT is 1 month after surgery	at start of PT, 2 months after start of PT
Secondary	Change in Passive Range of Motion as Assessed by Goniometer	Initiation of PT is 1 month after surgery	at start of PT, 5 months after start of PT
Secondary	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.	at start of PT, 1 month after start of PT
Secondary	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.	at start of PT, 2 months after start of PT
Secondary	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.	at start of PT, 5 months after start of PT
Secondary	Isometric quadriceps strength as Assessed by Dynamometer	Initiation of PT is 1 month after surgery.	1 month after start of PT
Secondary	Isometric quadriceps strength as Assessed by Dynamometer	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Isokinetic quadriceps strength as Assessed by Dynamometer	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT
Secondary	Functional Performance as Assessed by Balance Error Scoring System	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Balance Error Scoring System	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Overhead Squat Test	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Overhead Squat Test	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Y-Balance Test	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Y-Balance Test	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Single-Leg Squat Assessment	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Single-Leg Squat Assessment	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Vail Sport Test	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Vail Sport Test	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Landing Error Scoring System	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Landing Error Scoring System	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Functional Performance as Assessed by Single leg Hop Testing	Initiation of PT is 1 month after surgery.	2 months after start of PT
Secondary	Functional Performance as Assessed by Single leg Hop Testing	Initiation of PT is 1 month after surgery.	5 months after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Marx Scale	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Marx Scale	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Marx Scale	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT
Secondary	Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT
Secondary	Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT
Secondary	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	Initiation of PT is 1 month after surgery.	at start of PT, 1 month after start of PT
Secondary	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	Initiation of PT is 1 month after surgery.	at start of PT, 2 months after start of PT
Secondary	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	Initiation of PT is 1 month after surgery.	at start of PT, 5 months after start of PT