Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction

NCT04484961 | Completed Results

• 1 other identifier: Pro000138201
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study. One group underwent the normal ACL rehab protocol as determined by the participating surgeons. The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (3)

• Determine if BFR Changes Loss of LE Lean Muscle Mass

  LE lean muscle mass was measured in kilograms using DEXA (iDXA, GE®)

  Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery

• Determine if BFR Changes Loss of Bone Mass

  Bone mass was measured in grams using DEXA (iDXA, GE®)

  Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery

• Determine if BFR Changes Loss of Bone Mineral Density

  Bone mineral density was measured in grams/cm2 using DEXA (iDXA, GE®)

  Pre-surgery, 6 weeks post-surgery and 12 weeks post-surgery

Secondary Outcomes (7)

• Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing

  Week 8 and Week 12 post-surgery

• Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing

  8 weeks post surgery, 12 weeks post surgery

• Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing

  8 weeks post surgery, 12 weeks post surgery

• Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing

  8 weeks post surgery, 12 weeks post surgery

• Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing

  8 weeks post surgery, 12 weeks post surgery

Study Arms (2)

Control - Routine Rehab

NO INTERVENTION

Participants in this group received standard ACL rehab with no blood flow restriction therapy.

Experimental - BFR

EXPERIMENTAL

Participants in this group received standard ACL rehab with the addition of blood flow restriction therapy.

Device: Blood flow restriction (BFR)

Interventions

Blood flow restriction (BFR) DEVICE

The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.

Experimental - BFR

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-35
• Received ACL surgery with a patellar tendon autograft

You may not qualify if:

• Concomitant meniscal tear or additional ligamentous injury to the knee
• Obesity (BMI\>30)
• Diabetes
• Cardiovascular, renal, liver or pulmonary disease
• Active infections
• Cancer (current or treated within the past 2 years) or coagulation disorder
• Rapid weight change within the past year
• Physically unable to participate in the intervention
• Are not currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA. The NCAA banned substances list can be viewed from: http://www.ncaa.org/health-and-safety/policy/2014-15-ncaa-banned-drugs
• Unable to complete a minimum of 85% of the assigned rehabilitation sessions.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Related Publications (30)

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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: Bradley Lambert, PhD
• Organization: Houston Methodist Hospital

bslambert@houstonmethodist.org

8326872483

Study Officials

• Patrick McCulloch, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants were randomized to either receive standard physical therapy or standard physical therapy with blood flow restriction therapy.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 24, 2020
• Study Start: March 18, 2016
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share