[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586867":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":62,"studyPopulation":62,"armGroups":66,"interventions":87,"overallOfficials":100,"centralContacts":104,"locations":62,"responsibleParty":113,"collaborators":62,"id":115,"slug":62,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":62,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":62,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":141,"overallStatus":147,"whyStopped":62,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":62},{"fullName":5,"class":6},"University of Castilla-La Mancha","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":49},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Muscle Fatigue Reduction:","Evaluated through changes in biomarkers such as creatine kinase (CK), lactate dehydrogenase (LDH), and myoglobin levels, measured at multiple time points (pre- and post-intervention).","From pre-intervention to 48 hours post-intervention",{"measure":14,"description":15,"timeFrame":16},"Countermovement Jump (CMJ) test","Assessed using the countermovement jump (CMJ) test (cm)","From pre-intervention to 48 hours post-intervention.",{"measure":18,"description":19,"timeFrame":16},"Isometric Strenght Test (Hamstrings)","Assessed using isometric strength tests for the hamstrings (N)",{"measure":21,"description":22,"timeFrame":16},"Isometric Strenght Test (Adductor)","Assessed using isometric strength tests for the adductors (N)",{"measure":24,"description":25,"timeFrame":16},"Squat Performance","Assessed using squat performance with 50% body weight (reps)",[27,31,34,37,40,43,46],{"measure":28,"description":29,"timeFrame":30},"Perceived Recovery","Description: Assessed using the Wellness Questionnaire, which includes questions on perceived recovery.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate better perceived recovery.","At 24 and 48 hours post-intervention.",{"measure":32,"description":33,"timeFrame":30},"Stress Levels","Description: Assessed using the Wellness Questionnaire, which includes questions on stress levels.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher stress levels.",{"measure":35,"description":36,"timeFrame":30},"Fatigue","Description: Assessed using the Wellness Questionnaire, which includes questions on fatigue.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher levels of fatigue.",{"measure":38,"description":39,"timeFrame":30},"Muscle Soreness","Description: Assessed using the Wellness Questionnaire, which includes questions on muscle soreness.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate higher levels of muscle soreness.",{"measure":41,"description":42,"timeFrame":30},"Sleep Quality","Description: Assessed using the Wellness Questionnaire, which includes questions on sleep quality.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate better sleep quality.",{"measure":44,"description":45,"timeFrame":30},"Overall Well-Being","Description: Assessed using the Wellness Questionnaire, which includes questions on overall well-being.\n\nUnit of Measure: Score on a scale (1-10) Details: Higher scores indicate better overall well-being.",{"measure":47,"description":48,"timeFrame":16},"Thermographic Assessments","Monitoring skin temperature changes using thermography to evaluate the effectiveness of the recovery interventions.",[50,54],{"measure":51,"description":52,"timeFrame":53},"Injury Risk Assessment","Examining the association between recovery interventions and injury risk, based on the incidence of injuries recorded during the study period.","From baseline (enrollment) to 24 weeks post-intervention.",{"measure":55,"description":56,"timeFrame":16},"Concentration of 3-Methylhistidine in Urine","Description: Additional analysis of urine samples for markers such as 3-methylhistidine to assess muscle damage and recovery.\n\nUnit of Measure: Micrograms per liter (µg\u002FL)",{"allocation":58,"interventionModel":59,"interventionModelDescription":60,"primaryPurpose":61,"observationalModel":62,"timePerspective":62,"maskingInfo":63},"RANDOMIZED","CROSSOVER","This study employs a randomized crossover design to evaluate the effects of different recovery interventions on reducing muscle fatigue and improving performance in football players. The interventions include cold water immersion (CWI), hot water immersion (HWI), no immersion (NI), and thermography-guided immersion (TI).\n\nParticipants are randomly assigned to different intervention sequences, ensuring each participant receives all interventions in a random order. The study is divided into four blocks, each lasting five weeks. During each block, participants undergo one of the recovery interventions.\n\nInterventions:\n\nCWI: Five intermittent immersions of 2 minutes each in cold water (11°C). HWI: Continuous immersion of 18 minutes in hot water (38°C). NI: No immersion. TI: Based on thermographic assessments, participants receive either CWI or HWI. Outcome measures include muscle fatigue, performance metrics, biomarker levels, and subjective recovery assessments.","BASIC_SCIENCE",null,{"masking":64,"maskingDescription":65,"whoMasked":62},"NONE","We selected \"None (Open Label)\" for masking in this study for several reasons:\n\nPracticality and Feasibility: The interventions (cold and hot water immersions) are easily distinguishable by participants due to their distinct physical sensations, making blinding impractical.\n\nTransparency and Compliance: An open-label design allows full transparency with participants, enhancing compliance and cooperation as they understand the procedures and potential benefits.\n\nEthical Considerations: Providing complete information respects participants' autonomy and their right to make informed decisions about their participation, especially for physical interventions affecting their health.\n\nData Collection and Monitoring: The open-label design facilitates easier monitoring and data collection, improving accuracy and reliability without the need for complex blinding procedures.\n\nFocus on Objective Measures: The study relies on objective measures (thermography, biomarker analysis, performance tests)",[67,73,78,82],{"label":68,"type":69,"description":70,"interventionNames":71},"Cold Water Immersion (CWI)","EXPERIMENTAL","Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.",[72],"Other: Cold Water Immersion (CWI)",{"label":74,"type":69,"description":75,"interventionNames":76},"Hot Water Immersion (HWI)","Participants undergo a continuous immersion of 18 minutes in hot water (38°C).",[77],"Other: Hot water immersion (HWI)",{"label":79,"type":80,"description":81,"interventionNames":62},"No Immersion (NI)","NO_INTERVENTION","Participants follow the same protocol structure without any immersion.",{"label":83,"type":69,"description":84,"interventionNames":85},"Thermography-Guided Immersion (TI)","Based on thermographic assessments, participants with a hypothermic profile (decreased temperature) receive hot water immersion, while those with a hyperthermic profile (increased temperature) receive cold water immersion.",[86],"Other: Thermography-Guided Immersion (TI)",[88,92,98],{"type":6,"name":68,"description":70,"armGroupLabels":89,"otherNames":90},[68],[91],"Intermittent Cold Water Immersion (11ºC)",{"type":6,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Hot water immersion (HWI)","Participants undergo a continuous immersion of 18 minutes in hot water (38°C)",[74],[97],"Continuous hot water immersion (38ºC)",{"type":6,"name":83,"description":84,"armGroupLabels":99,"otherNames":62},[83],[101],{"name":102,"affiliation":5,"role":103},"Jose Luis Felipe, PhD","PRINCIPAL_INVESTIGATOR",[105,109],{"name":102,"role":106,"phone":107,"phoneExt":62,"email":108},"CONTACT","+34648885392","joseluis.felipe@uclm.es",{"name":110,"role":106,"phone":111,"phoneExt":62,"email":112},"Antonio Alonso, MsC","+34 615 45 09 89","antonio.alonso@uclm.es",{"type":114,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR","100586867",false,"NCT06920966","Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players","Inclusion Criteria:\n\nAge: Participants must be adults (18 years or older). Gender: Both male and female participants are eligible. Sport: Participants must be amateur football players. Team Membership: Participants must be members of a football team in the Castilla-La Mancha regional category.\n\nConsent: Participants must provide written informed consent to participate in the study.\n\nHealth: Participants must be in good general health, with no chronic illnesses or conditions that would contraindicate participation in physical activity or water immersion.\n\nExclusion Criteria:\n\nInjury: Participants who have sustained an injury that prevents them from participating in football activities for at least two weeks during any of the study blocks.\n\nMedical Conditions: Participants with medical conditions that contraindicate water immersion (e.g., severe cardiovascular conditions, open wounds, skin infections).\n\nWithdrawal: Participants who choose to withdraw from the study at any point. Non-compliance: Participants who do not comply with the study protocol or fail to attend scheduled sessions.\n\nPregnancy: Female participants who are pregnant or planning to become pregnant during the study period.",true,"ALL","18 Years","40 Years",{"count":125,"type":126},25,"ESTIMATED","INTERVENTIONAL",[129],"NA","The goal of this clinical trial is to evaluate if recovery interventions using cold and hot water immersion can reduce the risk of injuries in amateur soccer players.\n\nThe main questions it aims to answer are:\n\nDo cold water immersions reduce muscle fatigue and improve performance more effectively than hot water immersions? What is the optimal timing and duration for these recovery interventions to maximize their effectiveness?\n\nResearchers will compare:\n\nCold Water Immersion (CWI) Hot Water Immersion (HWI) No Immersion (NI) Thermographic Immersion (TI) based on individual thermal profiles\n\nParticipants will:\n\nUndergo thermographic assessments to determine their thermal profiles. Perform physical tests such as isometric strength tests, countermovement jumps (CMJ), and squats with 50% body weight.\n\nComplete wellness questionnaires to assess their subjective recovery and fatigue levels.\n\nProvide blood and urine samples for biomarker analysis. Participate in recovery interventions (CWI, HWI, or TI) based on their assigned group.",[132,133,134,135,136,137,138,139,140],"Muscle Fatigue (C23.888.592.612.612)","Athletic Injuries (C26.857.500.124)","Recovery of Function (G11.427.698.620)","Cryotherapy (E02.095.301.250)","Thermotherapy (E02.095.301.750)","Soccer (I03.450.642.845.750)","Biomarkers (D23.050.301)","Thermography (E01.370.350.700.750)","Physical Fitness (G11.427.410.698)",[142,143,144,145,146],"Muscle Fatigue","Recovery Interventions","Fatigue Reduction","Recovery Optimization","Physical Performance","NOT_YET_RECRUITING","2025-04-02",{"date":150,"type":151},"2025-04-10","ACTUAL",{"date":153,"type":126},"2025-05-01",{"date":155,"type":126},"2025-09-01",{"name":5,"class":6}]