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

NCT ID: NCT03096366

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

Quadriceps Atrophy; ACL Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Blood flow restriction

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: 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.

Interventions

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).

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Hermann Hospital

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Walter R Lowe

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter R Lowe, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Walter R Lowe, MD

Role: CONTACT

walter.r.lowe@uth.tmc.edu

713-486-6844

Facility Contacts

Walter R Lowe, MD

Role: primary

walter.r.lowe@uth.tmc.edu

713-486-6844

Other Identifiers

HSC-MS-16-1047

Identifier Type: -

Identifier Source: org_study_id