Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437470
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-25
Brief Title:
Effect of Blood Flow Restriction Technique After Anterior Cruciate Ligament Reconstruction
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Combined Effect Of Blood Flow Restriction Technique And Conventional Physical Therapy Program After Anterior Cruciate Ligament Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study will be to evaluate the effect of adding BFR using 80 of LOP to the conventional physical therapy program on knee function functional test balance quadriceps and hamstrings muscles strength thigh muscle girth and knee effusion in rehabilitation after ACLR
Detailed Description:
Anterior cruciate ligament ACL injury is one of the most common knee injuries especially in the age range 20 to 29 years It is commonly seen during sport activities including jumping pivoting or during contact with the other players Khalil et al 2023
Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction ACLR mainly due to weight bearing limitation in the early stage of rehabilitation Barber-Westin and Noyes 2019 and Hughes et al 2019 Recent rehabilitation protocols focused on range of motion ROM exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness Myer et al 2006 and Patterson et al 2019a
It is recommended by the American College of Sports Medicine to use 60 to 70 of one repetition maximum 1 RM to increase muscle strength and 70 to 80 of 1 RM to increase muscle size However using these percentage of loads in the early post-operative phase after ACLR may not be applicable Barber-Westin and Noyes 2019 Therefore therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase One of these protocols is the blood flow restriction training BFRT Patterson et al 2019a
The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise Scott et al 2015 This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles Manini and Clark 2009 In such environment muscle strength and hypertrophy can be reached by smaller external loads such as 20 or 30 of 1RM Loenneke et al 2012a This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus Loenneke et al 2012b and Arve et al 2020
The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases ligamentous injury and inflammatory diseases Hughes et al 2017 Early BFRT research designs used general measures to calculate cuff pressures such as setting pressure relative to systolic blood pressure thigh circumference or random pressures which is probably inaccurate especially with change in limb circumference or body position Takano et al 2005 and Loenneke et al 2015 A study performed by Khalil et al 2023 used the portable doppler ultrasound device to calculate limb occlusion pressure LOP of dorsalis pedis artery while manually inflating the restriction cuff This procedure is operator dependent and may lead to some errors especially in determining the exact location of the artery
Recent research recommends the use of individualized BFRT where the percentage of occlusion of the vascular structures is determined automatically for each individual separately Scott et al 2015
Previous studies concluded that BFRT after ACLR was effective in improving knee extension and flexion torques pain and balance Spada et al 2022 Bobes et al 2020 and Jung et al 2022 A recent systematic review performed by Colapietro et al 2023 found that limited studies included functional testing of the knee joint after BFRT which will be covered in this study using the latest wireless version of AirBands produced by VALD performance company which possesses the ability to automatically calculate LOP for each participant alone as recommended by the guidelines of Australian Institute of Sport
Up to the authors knowledge there was no study has investigated the effect of blood flow restriction BFR using 80 of LOP combined with the conventional physical therapy program on knee function and balance compared to the conventional physical therapy program alone after ACLR
Quadriceps and hamstrings muscle weakness and atrophy are commonly seen after Anterior cruciate ligament reconstruction ACLR mainly due to weight bearing limitation in the early stage of rehabilitation Barber-Westin and Noyes 2019 and Hughes et al 2019 Recent rehabilitation protocols focused on range of motion ROM exercises and increased muscle activation in the early post-operative phase to minimize complications such as joint stiffness and muscle weakness Myer et al 2006 and Patterson et al 2019a
It is recommended by the American College of Sports Medicine to use 60 to 70 of one repetition maximum 1 RM to increase muscle strength and 70 to 80 of 1 RM to increase muscle size However using these percentage of loads in the early post-operative phase after ACLR may not be applicable Barber-Westin and Noyes 2019 Therefore therapists considered it is necessary to find a safe exercise protocol designed to increase muscle strength and mass to be used in the early post-operative phase One of these protocols is the blood flow restriction training BFRT Patterson et al 2019a
The BFRT is a technique that restricts arterial and venous circulation in the working muscles during exercise Scott et al 2015 This technique uses a pneumatic tourniquet system that applies external pressure to the most proximal part of the arm or the thigh Cuff inflation causes compression on the vascular structures under the cuff leading to occlusion of the venous return and restriction of the arterial blood flow to the distal part of the limb This intentionally induced ischemic environment results in a state of hypoxia within the distal muscles Manini and Clark 2009 In such environment muscle strength and hypertrophy can be reached by smaller external loads such as 20 or 30 of 1RM Loenneke et al 2012a This makes the BFRT applicable in the early post-operative phase of rehabilitation without stressing the knee joint thus protecting the graft and minimizing the risk of increasing any associated injuries in cartilage or meniscus Loenneke et al 2012b and Arve et al 2020
The BFRT is beneficial for many groups such as geriatrics and those with degenerative joint diseases ligamentous injury and inflammatory diseases Hughes et al 2017 Early BFRT research designs used general measures to calculate cuff pressures such as setting pressure relative to systolic blood pressure thigh circumference or random pressures which is probably inaccurate especially with change in limb circumference or body position Takano et al 2005 and Loenneke et al 2015 A study performed by Khalil et al 2023 used the portable doppler ultrasound device to calculate limb occlusion pressure LOP of dorsalis pedis artery while manually inflating the restriction cuff This procedure is operator dependent and may lead to some errors especially in determining the exact location of the artery
Recent research recommends the use of individualized BFRT where the percentage of occlusion of the vascular structures is determined automatically for each individual separately Scott et al 2015
Previous studies concluded that BFRT after ACLR was effective in improving knee extension and flexion torques pain and balance Spada et al 2022 Bobes et al 2020 and Jung et al 2022 A recent systematic review performed by Colapietro et al 2023 found that limited studies included functional testing of the knee joint after BFRT which will be covered in this study using the latest wireless version of AirBands produced by VALD performance company which possesses the ability to automatically calculate LOP for each participant alone as recommended by the guidelines of Australian Institute of Sport
Up to the authors knowledge there was no study has investigated the effect of blood flow restriction BFR using 80 of LOP combined with the conventional physical therapy program on knee function and balance compared to the conventional physical therapy program alone after ACLR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None