Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621355
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
HemoNIRS a Paradigm Shift in the Process of Musculoskeletal Rehabilitation of ACL Injuries in Cyclic Sports Athletes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HemoNIRS Un Cambio De Paradigma En El Proceso De Rehabilitación Musculoesquelética De Lesiones De Ligamento Cruzado Anterior Mediante Dispositivos NIRS En Deportistas Que Realizan Deportes Cíclicos
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Muscle haemodynamics has so far been assessed using at most 2-3 near-infrared spectroscopy devices on isolated muscles and without correlating variables At the same time research on musculoskeletal pathologies is limited and there are no studies that analyse the haemodynamic changes that occur when the anterior cruciate ligament ACL is injured and whether these changes last over time The aim of the study is to monitor and evaluate the physiological changes produced by ACL injury on muscle performance using non-invasive near-infrared spectroscopy NIRS devices in trained athletes This descriptive cross-sectional observational multicentre multicentre study with Balearic Islands ethics committee IB 558524PI will include males aged 18-65 years who have undergone ACL surgery divided into 3 groups that have an evolution of less than 6 months ACL1 more than 2 years since the surgical intervention and are already practising normal physical-sports activities ACL2 and the control group CON that has never suffered an ACL affectation to date The 3 groups will perform an incremental intervallic test 41 on a cycloergometer or treadmill according to the specificity of their sport where different muscular haemodynamic variables will be assessed using 12-24 NIRS devices The main study variables will be the muscular haemodynamic values of each muscle analysed and their correlation between them muscular oxygen saturation absolute capillary haemoglobin loaded and unloaded with oxygen and relative muscular haemoglobin blood flow loaded and unloaded with oxygen Secondary variables will be heart rate socio-demographic variables age toxic habits injury and sports history and subjective perception of effort RPE-20
Detailed Description:
This study aims to investigate the physiological changes occurring in the musculoskeletal system during the rehabilitation process of ACL injuries using Near-Infrared Spectroscopy NIRS technology This study explores how NIRS devices can monitor muscle hemodynamics during specific rehabilitation exercises providing real-time insights into the muscle performance and recovery status of patients The research focuses on athletes who have undergone ACL surgery categorizing them into different groups based on the time since their surgical intervention lt6 months post-surgery and gt2 years post-surgery compared to a control group that has no history of ACL injury The study follows a multicenter observational cross-sectional descriptive design and is conducted across multiple healthcare centers including Físic Espai de Salut Integral Centre Re3MOVE MET Salut Hospital Universitari Son Espases and San Juan de Déu Palma-Inca These centers have been selected to ensure a diverse and representative sample of participants focusing on sports rehabilitation specialists and integrating technology for evaluating functional recovery and muscle performance during rehabilitation
The participants include male athletes aged 18 to 65 years who are divided into three distinct groups Group 1 LCA1 consists of athletes who have undergone ACL surgery within the last 6 months and are currently undergoing rehabilitation Group 2 LCA2 consists of athletes who have had ACL surgery more than 2 years ago and have returned to their normal sporting activities Group 3 control group consists of healthy athletes with no history of ACL injury The primary objective of the study is to evaluate the physiological and hemodynamic changes in muscle function during rehabilitation and to establish how these changes persist over time Additionally the study aims to identify residual physiological limitations in the musculoskeletal system post-rehabilitation and surgery The specific muscles of interest include the rectus femoris vastus lateralis gluteus maximus hamstrings and other stabilizing muscles in both the lower and upper body depending on the mode of exercise used in the evaluation
NIRS technology which is non-invasive will be employed to monitor muscle oxygen saturation SmO2 total hemoglobin concentration ThB oxygenated hemoglobin O2Hb and deoxygenated hemoglobin HHb in real time These measures will allow the researchers to assess the muscle39s oxidative capacity blood flow and overall performance during rehabilitative exercises The tests will be conducted using a cycle ergometer or treadmill depending on the participants sport and will follow an intervallic incremental protocol 4 minutes of work followed by 1 minute of rest increasing the workload incrementally until the participant reaches their maximum capability
The methodology incorporates the use of 12 to 24 portable NIRS devices attached to the participants39 muscles allowing for simultaneous real-time monitoring of muscle hemodynamics during exercise The devices will be linked to a central software system PeriPedal which will collect and analyze the data providing feedback to the researchers about muscle performance Secondary outcomes of the study include heart rate monitoring body composition using bioimpedance and skinfold thickness measurements and subjective perception of exertion using the RPE-20 scale Sociodemographic data such as age injury history and physical activity levels will also be collected to contextualize the findings
This study will adopt a pragmatic approach by incorporating the NIRS technology into routine clinical practice aiming to create a more holistic understanding of muscle hemodynamics during ACL rehabilitation The primary hypothesis of the study is that ACL injuries produce measurable changes in muscle hemodynamics that persist over time even after successful rehabilitation By identifying the factors that limit muscle performance in real-time the study seeks to provide clinicians with new tools to tailor rehabilitation programs more effectively and reduce the incidence of recurrent injuries
The findings from this study have the potential to transform the way musculoskeletal injuries are managed particularly in terms of rehabilitation strategies and monitoring techniques The study also aims to contribute to the broader understanding of how muscle performance is influenced by ACL injuries and rehabilitation ultimately improving patient outcomes in both clinical and athletic settings
In conclusion the HemoNIRS project is an innovative approach to understanding the physiological and hemodynamic changes in the musculoskeletal system following ACL injuries providing real-time data that can be used to optimize rehabilitation processes and enhance overall muscle performance
The participants include male athletes aged 18 to 65 years who are divided into three distinct groups Group 1 LCA1 consists of athletes who have undergone ACL surgery within the last 6 months and are currently undergoing rehabilitation Group 2 LCA2 consists of athletes who have had ACL surgery more than 2 years ago and have returned to their normal sporting activities Group 3 control group consists of healthy athletes with no history of ACL injury The primary objective of the study is to evaluate the physiological and hemodynamic changes in muscle function during rehabilitation and to establish how these changes persist over time Additionally the study aims to identify residual physiological limitations in the musculoskeletal system post-rehabilitation and surgery The specific muscles of interest include the rectus femoris vastus lateralis gluteus maximus hamstrings and other stabilizing muscles in both the lower and upper body depending on the mode of exercise used in the evaluation
NIRS technology which is non-invasive will be employed to monitor muscle oxygen saturation SmO2 total hemoglobin concentration ThB oxygenated hemoglobin O2Hb and deoxygenated hemoglobin HHb in real time These measures will allow the researchers to assess the muscle39s oxidative capacity blood flow and overall performance during rehabilitative exercises The tests will be conducted using a cycle ergometer or treadmill depending on the participants sport and will follow an intervallic incremental protocol 4 minutes of work followed by 1 minute of rest increasing the workload incrementally until the participant reaches their maximum capability
The methodology incorporates the use of 12 to 24 portable NIRS devices attached to the participants39 muscles allowing for simultaneous real-time monitoring of muscle hemodynamics during exercise The devices will be linked to a central software system PeriPedal which will collect and analyze the data providing feedback to the researchers about muscle performance Secondary outcomes of the study include heart rate monitoring body composition using bioimpedance and skinfold thickness measurements and subjective perception of exertion using the RPE-20 scale Sociodemographic data such as age injury history and physical activity levels will also be collected to contextualize the findings
This study will adopt a pragmatic approach by incorporating the NIRS technology into routine clinical practice aiming to create a more holistic understanding of muscle hemodynamics during ACL rehabilitation The primary hypothesis of the study is that ACL injuries produce measurable changes in muscle hemodynamics that persist over time even after successful rehabilitation By identifying the factors that limit muscle performance in real-time the study seeks to provide clinicians with new tools to tailor rehabilitation programs more effectively and reduce the incidence of recurrent injuries
The findings from this study have the potential to transform the way musculoskeletal injuries are managed particularly in terms of rehabilitation strategies and monitoring techniques The study also aims to contribute to the broader understanding of how muscle performance is influenced by ACL injuries and rehabilitation ultimately improving patient outcomes in both clinical and athletic settings
In conclusion the HemoNIRS project is an innovative approach to understanding the physiological and hemodynamic changes in the musculoskeletal system following ACL injuries providing real-time data that can be used to optimize rehabilitation processes and enhance overall muscle performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None