Blood Flow Restriction Training in ACL Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-18

Study Completion Date

2023-01-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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physical therapy with blood flow restriction

Group Type EXPERIMENTAL

blood flow restriction

Intervention Type OTHER

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

physical therapy without blood flow restriction

Standard of care.

Group Type OTHER

physical therapy standard of care

Intervention Type OTHER

the current standard of care after surgery for ACL repair.

Interventions

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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.

Intervention Type OTHER

physical therapy standard of care

the current standard of care after surgery for ACL repair.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No