Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury
DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training
+ Concentric Exercise with BLAST Leg Press System
+ Eccentric Exercise with BLAST Leg Press System
Anterior Cruciate Ligament Injuries+1
+ Knee Injuries
+ Leg Injuries
Treatment Study
Summary
Study start date: August 25, 2016
Actual date on which the first participant was enrolled.Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL) injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50% of surgically reconstructed limbs. Given that knee joint health following ACL injury is predicated on restoring quadriceps strength, identifying treatment approaches capable of improving strength is paramount. Blood flow restriction training (BFRT) is a method whereby oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to more timely and substantial strength gains. In the proposed project, we will examine the efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from quadriceps weakness. This project will have a randomized clinical trial design. Sixty patients that have torn their ACL and plan to undergo surgical reconstruction will be randomized into one of four groups: 1) eccentric exercise; 2) concentric exercise; 3) eccentric exercise with blood flow restriction; or 4) concentric exercise with blood flow restriction. All patients regardless of randomization assignment will also receive standard of care ACL rehabilitation. Approximately 6 weeks after ACL reconstruction surgery, patients will begin to receive the study interventions which will last for 8 weeks. The concentric exercise will be a leg press exercise done on a conventional leg press machine, while the eccentric exercise will be a leg press exercise done on a device designed to elicit eccentric muscle contractions. Patients will train at 70% of their 1 repetition maximum and will complete 4 sets of 10 contractions at each session (2 sessions/week). For patients randomized to the BFRT groups they will complete the leg press exercise while blood flow the the quadriceps muscle is restricted with a BFRT device (Delfi Personalized Tourniquet System for Blood Flow Restriction). We will quantify our dependent variables prior to surgical reconstruction, 6 weeks post-operatively (before study intervention starts), 14 weeks post-operatively (immediately after study intervention ends), and time of physician discharge from rehabilitation (e.g. time medical clearance for return to activity). The primary outcome is isokinetic quadriceps strength. We hypothesize that patients who complete eccentric exercise along with blood flow restriction training will realize the greatest gains in muscle strength. The DELFI PTS Personalized Tourniquet system is exempt from premarket notification and is therefore not subject to 510(k)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. suffered an acute, complete ACL rupture as confirmed by MRI 2. scheduled to undergo ACL reconstruction 3. scheduled to undergo ACL reconstruction with a surgeon affiliated with MedSport (University of Michigan Orthopaedic Clinic) 4. willing to undergo rehabilitation through MedSport (University of Michigan Orthopaedic Clinic) 5)) Willingness to participate in testing and follow-up as outlined in the protocol 6) English-speaking Exclusion Criteria: 1. inability to provide written informed consent (or assent) 2. female subjects who are pregnant or are planning to become pregnant during the study timeframe 3. previous ACL injury 4. previous surgery to either knee 5. bony fracture accompanying ACL injury 6. chronic ACL injuries (for our study, this is defined as patient reporting to a physician greater than 2 weeks after initial injury) 7. patients who experienced a knee dislocation 8. History of blood clots 9. Previous deep vein thrombosis 10. Use of estrogen or progestin contraceptive 11. History of cerebrovascular disease 12. History of peripheral vascular disease 13. History of Sickle Cell Anemia 14. History of chronic muscular disorder (e.g. fibromyalgia) 15. History of severe hypertension
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorGroup IV
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location