N/A
N=50
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
ACL Tear
Bottom Line
View on ClinicalTrials.gov: NCT04484961 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Determine if BFR Changes Loss of LE Lean Muscle Mass — 8.97; 8.97; 8.37; 8.93 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood flow restriction (BFR) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine if BFR Changes Loss of LE Lean Muscle Mass |
8.97; 8.97; 8.37; 8.93; 8.58; 9.04 | — |
| PRIMARY Determine if BFR Changes Loss of Bone Mass |
567.9; 568.2; 555; 567.2; 550.9; 565.4 | — |
| PRIMARY Determine if BFR Changes Loss of Bone Mineral Density |
1.2; 1.2; 1.1; 1.2; 1.1; 1.1 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
| SECONDARY Does BFR Change the Number of Exercise Repetitions in Functional Physical Therapy Testing |
29.9; 28.2; 38.5; 37.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Ages 18-35
- Received ACL surgery with a patellar tendon autograft
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04484961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.