NCT03096366

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

5 years

First QC Date

March 23, 2017

Last Update Submit

May 3, 2022

Conditions

Quadriceps AtrophyACL Reconstruction

Keywords

anterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (41)

  • Change in Passive Range of Motion as Assessed by Goniometer

    at start of PT, 1 month after start of PT

  • Change in Passive Range of Motion as Assessed by Goniometer

    at start of PT, 2 months after start of PT

  • Change in Passive Range of Motion as Assessed by Goniometer

    at start of PT, 5 months after start of PT

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

    at start of PT, 1 month after start of PT

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

    at start of PT, 2 months after start of PT

  • +36 more secondary outcomes

Study Arms (2)

Physical therapy (PT) plus blood flow restriction (BFR)

EXPERIMENTAL

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).

Device: Blood flow restrictionOther: Physical therapy

Physical therapy

ACTIVE COMPARATOR

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.

Other: Physical therapy

Interventions

Blood flow restrictionDEVICE

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 (PT) plus blood flow restriction (BFR)
Physical therapyOTHER

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 therapyPhysical therapy (PT) plus blood flow restriction (BFR)

Eligibility Criteria

Age14 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to attend (or participate in) physical therapy
  • Pregnancy
  • Malignancy
  • Fracture
  • Peripheral vascular disease
  • History of deep vein thrombosis (DVT)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Interventions

Blood Flow Restriction TherapyPhysical Therapy Modalities

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Walter R Lowe, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter R Lowe, MD

CONTACT

713-486-6844walter.r.lowe@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding is not possible given the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 30, 2017

Study Start

November 21, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 4, 2022

Record last verified: 2022-05

Locations

US(1)