The Effect of Various Strength Training Protocols in ACL Reconstructed Participants

NCT03364647 | Completed Results DMC

• 2 other identifiers: 15-0750-F6AR01AR071398
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working. There will be no charge to the participant for their physical therapy visits as long as they are part of the study The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires). The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form. The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.

Conditions

Anterior Cruciate Ligament (ACL) Tear; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• Measure Change in Isometric Peak Torque Quadriceps Strength

  Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

  Baseline, and post-surgery (up to 5 months)

• Measure Change in Isokinetic Peak Torque Quadriceps Strength

  Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

  Baseline and post-surgery (up to 5 months)

• Measure Change in Rate of Torque Development

  Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.

  Baseline and post-surgery (up to 5 months)

Secondary Outcomes (4)

• Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time

  Baseline, Post-surgery (up to 5 months)

• Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA)

  Baseline, Post-surgery (up to 5 months)

• Measure Change in Knee Biomechanics - Peak Knee Flexion

  Baseline and post-surgery (up to 5 months)

• Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM)

  Baseline and post-surgery (up to 5 months)

Other Outcomes (1)

• Measure the Change in Muscle Physiology After Using BFRT for Treatment in Patients Who Will Have an ACL Reconstruction.

  Before surgery, 4 months after surgery

Study Arms (2)

Arm A - Blood flow restriction training

EXPERIMENTAL

Group will use blood flow restriction training and standard of care

Other: Arm A - blood flow restriction training

Arm B - standard of care plus sham

SHAM COMPARATOR

Group will receive standard of care plus a sham version of blood flow restriction training

Other: Arm B - standard of care

Interventions

Arm A - blood flow restriction training OTHER

Group receive standard of care plus blood flow restriction training

Arm A - Blood flow restriction training

Arm B - standard of care OTHER

Group will receive standard of care plus a sham version of blood flow restriction training

Arm B - standard of care plus sham

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ACL tear and no previous ACL reconstruction on either the involved or other limb

You may not qualify if:

• Previous surgeries or conditions that might affect gait
• Any current condition other than ACL or meniscus injury which might affect gait
• Unable to provided informed consent
• Diabetic or have uncontrolled hypertension
• Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
• Allergic to Betadine or Xylocaine HCL.
• Taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa that may cause excess bleeding.
• Any implanted medical device
• A history of deep vein thrombosis, have a family history of deep vein thrombosis, or varicose veins
• Spinal fusion
• Inability able to attend regular physical therapy or study visits
• Injury occurring more than ten weeks prior to study enrollment
• Not skeletally mature (growth plates not closed)

Sponsors & Collaborators

• Brian W. Noehren: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (2)

University of Kentucky Orthopaedics and Sports Medicine Center

Lexington, Kentucky, 40504, United States

Location

University of Kentucky BioMotion Laboratory, 725 Rose Street

Lexington, Kentucky, 40536-0082, United States

Location

Related Publications (2)

• Erickson LN, Owen MK, Casadonte KR, Janatova T, Lucas K, Spencer K, Brightwell BD, Graham MC, White MS, Thomas NT, Latham CM, Jacobs CA, Conley CE, Thompson KL, Johnson DL, Hardy PA, Fry CS, Noehren B. The Efficacy of Blood Flow Restriction Training to Improve Quadriceps Muscle Function after Anterior Cruciate Ligament Reconstruction. Med Sci Sports Exerc. 2025 Feb 1;57(2):227-237. doi: 10.1249/MSS.0000000000003573. Epub 2024 Oct 1.

  PMID: 39350350 DERIVED

• Erickson LN, Lucas KCH, Davis KA, Jacobs CA, Thompson KL, Hardy PA, Andersen AH, Fry CS, Noehren BW. Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial. Phys Ther. 2019 Aug 1;99(8):1010-1019. doi: 10.1093/ptj/pzz062.

  PMID: 30951598 DERIVED

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Brian Noehren
• Organization: University of Kentucky

b.noehren@uky.edu

859-323-1100

Study Officials

• Brian Noehren, PT., Ph.D

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcomes assessors, and the PI will be blinded as to the participant's group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 6, 2017
• Study Start: August 21, 2017
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: January 13, 2025
• Results First Posted: December 4, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)