Back to resultsBFR in ACL Surgery
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blood flow restriction
physical therapy standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries
Eligibility Criteria
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.
Sites / Locations
- UAMS Center on Aging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
physical therapy with blood flow restriction
physical therapy without blood flow restriction
Arm Description
Standard of care.
Outcomes
Primary Outcome Measures
Maximal Voluntary Contraction
Max torque produced in newton meter per second during an isometric contraction
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05245864
Brief Title
BFR in ACL Surgery
Official Title
Use of Blood Flow Restriction + Progressive Resistance Functional Training to Improve Functional Outcomes After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting subjects; funding not renewed.
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
physical therapy with blood flow restriction
Arm Type
Experimental
Arm Title
physical therapy without blood flow restriction
Arm Type
Other
Arm Description
Standard of care.
Intervention Type
Other
Intervention Name(s)
blood flow restriction
Intervention Description
Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
Intervention Type
Other
Intervention Name(s)
physical therapy standard of care
Intervention Description
the current standard of care after surgery for ACL repair.
Primary Outcome Measure Information:
Title
Maximal Voluntary Contraction
Description
Max torque produced in newton meter per second during an isometric contraction
Time Frame
16-weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arny A Ferrando, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAMS Center on Aging
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BFR in ACL Surgery
We'll reach out to this number within 24 hrs