Blood Flow Restriction Training in ACL Surgery

Not Applicable

Terminated

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Other: blood flow restriction; Other: physical therapy standard of care

• Registration Number: NCT05245864
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-18
• Study Start: 2022-04-18
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-03
• Results First Submitted: 2023-07-05
• Results First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
physical therapy with blood flow restriction	blood flow restriction	-
physical therapy without blood flow restriction	physical therapy standard of care	Standard of care.

Primary Outcome Measures

Name	Time	Method
Maximal Voluntary Contraction	16-weeks post-surgery	Max torque produced in newton meter per second during an isometric contraction
ACL Repair Range of Motion	from enrollment to the end of treatment at 16 weeks	Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.

Trial Locations

Locations (1)

UAMS Center on Aging; 🇺🇸 Little Rock, Arkansas, United States