Anterior Cruciate Ligament Injuries
Conditions
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.
Interventions
OTHERblood flow restriction
Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
OTHERphysical therapy standard of care
the current standard of care after surgery for ACL repair.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Physical Therapy With Blood Flow Restriction 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. | 1 |
| Physical Therapy Without Blood Flow Restriction Standard of care.
physical therapy standard of care: the current standard of care after surgery for ACL repair. | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
ACL Repair Range of Motion
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
Time frame: from enrollment to the end of treatment at 16 weeks
Population: No participant completed this measure.
Primary
Maximal Voluntary Contraction
Max torque produced in newton meter per second during an isometric contraction
Time frame: 16-weeks post-surgery
Population: Participant who did Physical therapy without blood flow restriction completed only enrollment and pre testing. Participant who completed physical therapy with blood flow restriction completed only enrollment, pre testing, and one post operative testing visit.