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Blood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury

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Qué se está evaluando

DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training

+ Concentric Exercise with BLAST Leg Press System

+ Eccentric Exercise with BLAST Leg Press System

DispositivoOtro
Quiénes están siendo reclutados

Lesiones del Ligamento Cruzado Anterior+1

+ Lesiones de la rodilla

+ Lesiones de la pierna

De 14 a 30 años
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Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: agosto de 2016
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Michigan
Última actualización: 18 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 25 de agosto de 2016

Fecha en la que se inscribió al primer participante.

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)

Título OficialBlood Flow Restriction Training to Improve Muscle Strength and Function Following Anterior Cruciate Ligament Injury 
NCT03141801
Patrocinador PrincipalUniversity of Michigan
Última actualización: 18 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 48 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 14 a 30 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Lesiones del Ligamento Cruzado AnteriorLesiones de la rodillaLesiones de la piernaHeridas y Lesiones

Criterios

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

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

4 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

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.

Grupo II

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%.

Grupo III

Comparador Activo
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.

Grupo IV

Comparador Activo
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%.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

University of Michigan

Ann Arbor, United StatesVer ubicación
Completado1 Centros de Estudio