BFR in ACL Surgery

Sponsor

University of Arkansas (Other)

Overall Status

Recruiting

CT.gov ID

NCT05245864

Collaborator

(none)

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Injuries	Other: blood flow restriction Other: physical therapy standard of care	N/A

Detailed Description

This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.

Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.

Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction

Actual Study Start Date :

Apr 18, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: physical therapy with blood flow restriction	Other: blood flow restriction Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
Other: physical therapy without blood flow restriction Standard of care.	Other: physical therapy standard of care the current standard of care after surgery for ACL repair.

Arm

Intervention/Treatment

Experimental: physical therapy with blood flow restriction

Other: blood flow restriction

Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.

Other: physical therapy without blood flow restriction

Standard of care.

Other: physical therapy standard of care

the current standard of care after surgery for ACL repair.

Outcome Measures

Primary Outcome Measures

Maximal Voluntary Contraction [16-weeks post-surgery]
Max torque produced in newton meter per second during an isometric contraction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 34 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women, ages 18-34 years.
Scheduled to undergo elective ACL surgery at UAMS.
Capable of providing informed consent.
Willing to exercise with BFR.
COVID-19 negative or asymptomatic.

Exclusion Criteria:

Any surgical indication other than ACL repair.
Body mass index >40.
Pregnant female.
Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.
Heart failure as evidenced by use of prescription diuretics.
History of atrial fibrillation.
Oxygen saturation <95% on room air at rest.
Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
Compromised vascular circulation in the legs (e.g. peripheral vascular disease).
History of deep vein thrombosis.
Varicose veins in the legs.
Known Sickle cell disease or trait.
Unwilling to avoid using protein or amino-acid supplements during participation.
Unwilling to avoid using BFR during prescribed post-operative physical therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAMS Center on Aging	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator: Arny A Ferrando, Ph.D., University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT05245864

Other Study ID Numbers:

261865

First Posted:

Feb 18, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Apr 25, 2022