BFR in ACL Surgery

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05245864
• Other study ID #: 261865
• Status: Terminated
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

1. Men and women, ages 18-34 years.

2. Scheduled to undergo elective ACL surgery at UAMS.

3. Capable of providing informed consent.

4. Willing to exercise with BFR.

5. COVID-19 negative or asymptomatic.

Exclusion Criteria:

1. Any surgical indication other than ACL repair.

2. Body mass index >40.

3. Pregnant female.

4. Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.

5. Hypertension as evidenced by systolic BP >150 at rest OR diastolic BP >85 at rest.

6. Heart failure as evidenced by use of prescription diuretics.

7. History of atrial fibrillation.

8. Oxygen saturation <95% on room air at rest.

9. Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.

10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.

11. Compromised vascular circulation in the legs (e.g. peripheral vascular disease).

12. History of deep vein thrombosis.

13. Varicose veins in the legs.

14. Known Sickle cell disease or trait.

15. Unwilling to avoid using protein or amino-acid supplements during participation.

16. Unwilling to avoid using BFR during prescribed post-operative physical therapy.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

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.
• physical therapy standard of care
the current standard of care after surgery for ACL repair.

Locations

Country	Name	City	State
United States	UAMS Center on Aging	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Voluntary Contraction	Max torque produced in newton meter per second during an isometric contraction	16-weeks post-surgery