Blood Flow Restriction After Anterior Cruciate Ligament Reconstruction (ACLR)

NCT05500872 | Completed

• 1 other identifier: KA-19118
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Muscle strength and muscle volume decrease rapidly with the immobilization process after sports-related injury and surgery. Depending on the decrease in muscle strength and muscle volume, functional performance also deteriorates, and this has been demonstrated by studies in the literature. Despite rehabilitation programs after anterior cruciate ligament surgery, muscle weakness persists for a long time and this affects knee functions. As a result, the time to return to sports is delayed or the activity level decreases. In recent studies, cross training is used to gain strength. Cross training is the increase in strength in the untrained leg after unilateral strengthening of the untrained leg. Another popular application for strength gain is exercise training with blood flow restriction. Blood flow restriction exercise training is an exercise protocol based on external pressure restriction of blood flow through the cuff from the proximal of the target muscle. It has been shown that this training prevents reduction of muscle volume in the early postoperative period and increases muscle strength. In the literature, cross-training and blood flow-restricted training are applied separately for muscle strength development after ACL reconstruction. However, no study investigating the effect of the combined application of these two approaches on muscle strength during ACL rehabilitation has been found. It is thought that with the combined application of these approaches, their effects on muscle strength development will increase, and accordingly, the functional results of individuals will be positively affected. The aim of the study is to determine the effect of cross training applied with and without blood flow restriction on muscle strength and function for 8 weeks starting from the 4th week after anterior cruciate ligament surgery. Participants will be included in the training for a total of 16 sessions, 2 days a week for 8 weeks. Pain, muscle strength, muscle thickness, knee functions will be evaluated before and after the training.

Conditions

Anterior Cruciate Ligament Rupture; Quadriceps Muscle Atrophy

Keywords

Anterior cruciate ligament; Strength training; Atrophy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Muscle Strength at 12th week

  Isometric muscle strength will be evaluated with isokinetic system. A 5-minute warm-up will be done before the test. After warming up, 5 repetitive hamstring stretching exercises will be performed on both extremities. The patients will then be seated on the isokinetic dynamometer seat with the trunk upright and the hips flexed to 90°, and the person will be positioned. The tests will be performed first on the unaffected side for each patient. Before starting the test, the test procedure will be explained to the patients in detail and the tests will be practiced once. For the quadriceps isometric muscle test, the patient will be asked to push the leg upwards with maximum force for 5 seconds. For the hamstring isometric muscle test, he will be asked to pull the leg down with maximum force. he test will be performed with three repetitions for each muscle and 2 minutes of rest will be given between repetitions to reduce the effect of fatigue. The results will be recorded in Nm/kg.

  4th and 12th week after surgery

Secondary Outcomes (4)

• Change from Baseline Muscle Thickness at 12th week

  4th and 12th week after surgery

• Change from Baseline Knee Function at 12th week

  4th and 12th week after surgery

• Change from Baseline Knee Function at 12th week

  4th and 12th week after surgery

• Change from Baseline Knee Function at 12th week

  4th and 12th week after surgery

Study Arms (2)

BFR Group

EXPERIMENTAL

Cross-education will be performed for 8 weeks with blood flow restriction in the unaffected extremity in the isokinetic system.

Other: Cross-education and blood flow restriction training

Control Group

ACTIVE COMPARATOR

Cross-education will be performed for 8 weeks without applying blood flow restriction in the isokinetic system.

Other: Cross-education

Interventions

Cross-education and blood flow restriction training OTHER

Cross-education (training of the non-surgical leg) will be given to the participants in addition to the standard rehabilitation program after surgery. This training will be applied with isokinetic system that can be used safely in the rehabilitation field. During this training, a cuff will be worn from the upper part of the thigh muscles, as in the blood pressure devices, which will slow down the blood flow in the leg. The participant will be cross-educated with the cuff inflated to a safe pressure range that will not cause discomfort. Participants will be included in the training for a total of 16 sessions, 2 days a week for 8 weeks. Each session, cross-education will be applied as 3 sets of 12 repetitions. Pain, muscle strength, muscle thickness, knee functions will be evaluated before and after the training.

BFR Group

Cross-education OTHER

Cross-education (training of the non-surgical leg) will be given to the participants in addition to the standard rehabilitation program after surgery. This training will be applied with isokinetic system that can be used safely in the rehabilitation field. Participants will be included in the training for a total of 16 sessions, 2 days a week for 8 weeks. Each session, cross-education will be applied as 3 sets of 12 repetitions. Pain, muscle strength, muscle thickness, knee functions will be evaluated before and after the training.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Undergone reconstruction surgery with hamstring tendon graft due to unilateral anterior cruciate ligament tear,
• Absence of any injury in the intact extremity for at least 6 months
• Being recreationally active

You may not qualify if:

• Systemic or neurological problems
• History of deep vein thrombosis, peripheral vascular diseases
• Hypertension, cardiovascular diseases, neurological diseases, systemic inflammation, obesity, diabetes, atherosclerosis, advanced age)
• Active infection
• Having cancer
• Being pregnant
• Presence of posterior cruciate ligament tear in addition to the ACL
• Third degree tear in the lateral and medial collateral ligaments and and prominent articular cartilage lesion in addition to the ACL

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Atrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The thickness and cross-sectional area of the quadriceps muscle (rectus femoris, vastus medialis obliques, vastus lateralis) will be measured by ultrasonography before and after each participant's training (4th week and 12th week after surgery). The person making these measurements will not know which group the participants belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reasearch Assistant

Model Details: Our study was planned to be randomized controlled. Individuals will be stratified into 2 groups (Group I, Group II) based on the order of arrival using the Excel program. After the 4th postoperative week, cross-training will be applied to both groups for 8 weeks in addition to the rehabilitation program. In the study group, cross-education will be performed for 8 weeks with blood flow restriction in the unaffected extremity in the isokinetic system. In the control group, cross-education will be performed for 8 weeks without applying blood flow restriction in the isokinetic system. Before and after cross education, individuals; pain (rest, activity), leg circumference measurement, quadriceps and hamstring muscle strength (isokinetic dynamometer), quadriceps muscle thickness, cross-sectional area (ultrasound) and knee function (IKDC questionnaire, KOOS questionnaire, tampa questionnaire) will be evaluated.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: August 30, 2022
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

TU (1)