Blood Flow Restriction Training in ACL Surgery

NCT05245864 | Terminated Results

• 1 other identifier: 261865
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (2)

• Maximal Voluntary Contraction

  Max torque produced in newton meter per second during an isometric contraction

  16-weeks post-surgery

• 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.

  from enrollment to the end of treatment at 16 weeks

Study Arms (2)

physical therapy with blood flow restriction

EXPERIMENTAL

Other: blood flow restriction

physical therapy without blood flow restriction

OTHER

Standard of care.

Other: physical therapy standard of care

Interventions

blood flow restriction 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 with blood flow restriction

physical therapy standard of care OTHER

the current standard of care after surgery for ACL repair.

physical therapy without blood flow restriction

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

UAMS Center on Aging

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Arny A. Ferrando
• Organization: UAMS

AFerrando@uams.edu

501-526-5711

Study Officials

• Arny A Ferrando, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 18, 2022
• Study Start: April 18, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)