Blood Flow Restriction to Improve Muscle Strength After ACL Injury

NCT03141801 | Completed

• 1 other identifier: HUM00110455
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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 where 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 substantial quadriceps weakness.

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACL; Knee; Muscle

Outcome Measures

Primary Outcomes (1)

• Change from baseline to return to activity in quadriceps muscle strength

  concentric isokinetic muscle strength at 60 degrees per second

  Pre-surgery (baseline), Return to Activity (~9 months post-surgery)

Secondary Outcomes (5)

• Knee Flexion Angle

  Return to Activity (~9 months post-surgery)

• Knee Flexion Moment

  Return to Activity (~9 months post-surgery)

• Change from baseline to pre-intervention in PROMIS Global Health Scale

  Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)

• Change from baseline to post-intervention in PROMIS Global Health Scale

  Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery)

• Change from baseline to return to activity in PROMIS Global Health Scale

  Pre-surgery (baseline),Return to Activity (~9 months post-surgery)

Other Outcomes (3)

• Change from baseline to pre-intervention in quadriceps cross-sectional area

  Pre-surgery (baseline), Pre-intervention (~10 weeks post-surgery)

• Change from baseline to post-intervention in quadriceps cross-sectional area

  Pre-surgery (baseline), Post-intervention (~18 weeks post-surgery)

• Change from baseline to return to activity in quadriceps cross-sectional area

  Pre-surgery (baseline), Return to Activity (~9 months post-surgery)

Study Arms (4)

Eccentric Exercise with Delfi Blood Flow Restriction Training

EXPERIMENTAL

Patients randomized to the eccentric exercise + blood flow restriction training group will receive eccentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their eccentric 1-repetition maximum for 4 sets of 10 repetitions. During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a limb occlusion pressure of 80%.

Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training; Other: Eccentric Exercise with BLAST Leg Press System

Concentric Exercise with Delfi Blood Flow Restriction Training

EXPERIMENTAL

Patients randomized to the concentric exercise group will receive concentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their concentric 1-repetition maximum for 4 sets of 10 repetitions.

Device: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training; Other: Concentric Exercise with BLAST Leg Press System

Eccentric Exercise

ACTIVE COMPARATOR

Patients randomized to the eccentric exercise group will receive eccentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their eccentric 1-repetition maximum for 4 sets of 10 repetitions.

Other: Eccentric Exercise with BLAST Leg Press System

Concentric Exercise

ACTIVE COMPARATOR

Patients randomized to the concentric exercise group will receive concentric exercise two times per week for 8 weeks, beginning 8-12 weeks after anterior cruciate ligament reconstruction. Patients will completed the exercise with knee range of motion limited to 20-60 degrees of knee flexion and will train at an intensity equal to 70% of their concentric 1-repetition maximum for 4 sets of 10 repetitions. During exercise, patients will have the DELFI personalized tourniquet system applied over the quadriceps to restrict blood flow. The tourniquet will be set to a limb occlusion pressure of 80%.

Other: Concentric Exercise with BLAST Leg Press System

Interventions

DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training DEVICE

cuff is inflated to 80% of an individuals limb occlusion pressure

Also known as: Kaatsu Training

Concentric Exercise with Delfi Blood Flow Restriction Training; Eccentric Exercise with Delfi Blood Flow Restriction Training

Eccentric Exercise with BLAST Leg Press System OTHER

4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum

Eccentric Exercise; Eccentric Exercise with Delfi Blood Flow Restriction Training

Concentric Exercise with BLAST Leg Press System OTHER

4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum

Concentric Exercise; Concentric Exercise with Delfi Blood Flow Restriction Training

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• suffered an acute, complete ACL rupture as confirmed by MRI
• scheduled to undergo ACL reconstruction
• scheduled to undergo ACL reconstruction with a surgeon affiliated with MedSport (University of Michigan Orthopaedic Clinic)
• 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
• \) English-speaking

You may not qualify if:

• inability to provide written informed consent (or assent)
• female subjects who are pregnant or are planning to become pregnant during the study timeframe
• previous ACL injury
• previous surgery to either knee
• bony fracture accompanying ACL injury
• chronic ACL injuries (for our study, this is defined as patient reporting to a physician greater than 2 weeks after initial injury)
• patients who experienced a knee dislocation
• History of blood clots
• Previous deep vein thrombosis
• Use of estrogen or progestin contraceptive
• History of cerebrovascular disease
• History of peripheral vascular disease
• History of Sickle Cell Anemia
• History of chronic muscular disorder (e.g. fibromyalgia)
• History of severe hypertension

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Curran MT, Bedi A, Mendias CL, Wojtys EM, Kujawa MV, Palmieri-Smith RM. Blood Flow Restriction Training Applied With High-Intensity Exercise Does Not Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(4):825-837. doi: 10.1177/0363546520904008.

  PMID: 32167837 DERIVED

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

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: Associate Professor

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 5, 2017
• Study Start: August 25, 2016
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)