[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563837":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":35,"locations":10,"responsibleParty":44,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":10},{"fullName":5,"class":6},"Universitat de Lleida","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"LCA1",null,"Patients with ACL involvement (with less than 6 months of evolution since the surgical intervention (IQ)) and are in a phase in which they can perform the incremental intervallic test either on a cycloergometer or treadmill.",[13],"Other: Physical fitness test: Progressive intervalic test",{"label":15,"type":10,"description":16,"interventionNames":17},"LCA2","Patients who have recovered from an ACL injury for more than 2 years. And can perform the incremental intervallic test either on a cycloergometer or treadmill.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"CON","Patients who have never suffered an ACL injury or involvement to date. And can also perform the test.",[13],[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Physical fitness test: Progressive intervalic test","An incremental interval test of 4\\' of work for 1\\' of rest will be performed at an individual intensity below the aerobic threshold. At the end of the rest minute, the load shall be increased slightly. In order to be as adjusted and individualised as possible, the subjective physical condition level stated by the patient during the sociodemographic data collection shall be taken as a reference for the establishment of the initial load, being a value of power (W) in cycle ergometer and speed (km\u002Fh) in treadmill. Never less than 50W or 6 km\u002Fh, respectively.\n\nThe minimum incremental values will be 25W or 0.5km\u002Fh until you are unable to complete a full interval. An incomplete interval shall also be recorded and analysed.\n\nDuring the one minute rest period, as will have been well emphasised during the explanation of the test, no part of the body may be moved at all, so at the end of the 4 minutes of work, the evaluator will count down for the patient to get ready and remain stil",[19,9,15],[28],"Physical fitness test",[30,33],{"name":31,"affiliation":5,"role":32},"Francesc Valenzuela-Pascual, PhD","STUDY_DIRECTOR",{"name":34,"affiliation":5,"role":32},"Oriol Martínez-Navarro, PhD",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Francisco J. Verdejo-Amengual","CONTACT","+34 670729376","xisco.verdejo@udl.cat",{"name":34,"role":38,"phone":42,"phoneExt":10,"email":43},"+34 619562618","oriol.martinez@udl.cat",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Xisco Verdejo","PhD Student and Associate Professor","100563837","hemonirs-a-paradigm-shift-in-the-process-of-musculoskeletal-rehabilitation-of-acl-injuries-in-cyclic-sports-athletes-100563837",false,"NCT06621355","HemoNIRS: a Paradigm Shift in the Process of Musculoskeletal Rehabilitation of ACL Injuries in Cyclic Sports Athletes.","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","General inclusion criteria\n\n* Men aged 18 to 65\n* An adipose layer of \\<2 cm in areas of NIRS placement, assessed with a plicometer\n* Understand written, read and spoken Spanish, English or Catalan.\n\nGeneral exclusion criteria\n\n* Having any cardio-metabolic, hormonal, neurological or other comorbidities that could affect participation in the study (e.g. severe mental illness, end-stage disease).\n\nEligibility criteria (LCA1 group)\n\n* Regular athlete with training and\u002For competition \\>3 days\u002Fwk prior to injury.\n* ACL injury \\<6 months after surgery.\n* Able to perform an incremental intervallic test on a cycloergometer or treadmill.\n\nEligibility criteria (LCA2 group)\n\n* Regular athlete with training and\u002For competition \\>3 days a week.\n* ACL injury \\>2 years after surgery.\n* Able to perform an incremental intervallic test on a cycloergometer or treadmill.\n\nEligibility criteria (CON group)\n\n* Regular athlete with training and\u002For competition \\>3 days a week.\n* Never suffered an ACL injury in any knee - Able to perform incremental intervallic test on cycleergometer or treadmill.\n\nAll the groups exclusion criteria\n\n\\- Incapacitating pain that prevents assessment",true,"MALE","18 Years","65 Years",{"count":60,"type":61},129,"ESTIMATED","1 Day","OBSERVATIONAL","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 5585\u002F24PI, 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 (4:1) 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).",[66,67,68,69,70],"ACL - Anterior Cruciate Ligament Rupture","ACL Injury","Hemodynamics","Oxygen Consumption Based Assessment of Hemodynamics","Exercise",[72,68,70,73,74],"Spectroscopy, Near-Infrared","Vascular resistance","Oxygen consumption","NOT_YET_RECRUITING","2024-09-27",{"date":78,"type":79},"2024-10-01","ACTUAL",{"date":81,"type":61},"2024-12-02",{"date":83,"type":61},"2026-12-02",{"name":5,"class":6}]