Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-28 @ 12:32 AM
Study NCT ID:
NCT06920966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2025-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001265', 'term': 'Athletic Injuries'}, {'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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)'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Injury Risk Assessment', 'timeFrame': 'From baseline (enrollment) to 24 weeks post-intervention.', 'description': 'Examining the association between recovery interventions and injury risk, based on the incidence of injuries recorded during the study period.'}, {'measure': 'Concentration of 3-Methylhistidine in Urine', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': '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/L)'}], 'primaryOutcomes': [{'measure': 'Muscle Fatigue Reduction:', 'timeFrame': 'From pre-intervention to 48 hours post-intervention', 'description': '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).'}, {'measure': 'Countermovement Jump (CMJ) test', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': 'Assessed using the countermovement jump (CMJ) test (cm)'}, {'measure': 'Isometric Strenght Test (Hamstrings)', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': 'Assessed using isometric strength tests for the hamstrings (N)'}, {'measure': 'Isometric Strenght Test (Adductor)', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': 'Assessed using isometric strength tests for the adductors (N)'}, {'measure': 'Squat Performance', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': 'Assessed using squat performance with 50% body weight (reps)'}], 'secondaryOutcomes': [{'measure': 'Perceived Recovery', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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.'}, {'measure': 'Stress Levels', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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': 'Fatigue', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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': 'Muscle Soreness', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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': 'Sleep Quality', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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': 'Overall Well-Being', 'timeFrame': 'At 24 and 48 hours post-intervention.', 'description': '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': 'Thermographic Assessments', 'timeFrame': 'From pre-intervention to 48 hours post-intervention.', 'description': 'Monitoring skin temperature changes using thermography to evaluate the effectiveness of the recovery interventions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Muscle Fatigue', 'Recovery Interventions', 'Fatigue Reduction', 'Recovery Optimization', 'Physical Performance'], 'conditions': ['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)']}, 'referencesModule': {'references': [{'pmid': '32560317', 'type': 'BACKGROUND', 'citation': 'Lorenzo Calvo J, Alorda-Capo F, Pareja-Galeano H, Jimenez SL. Influence of Nitrate Supplementation on Endurance Cyclic Sports Performance: A Systematic Review. Nutrients. 2020 Jun 17;12(6):1796. doi: 10.3390/nu12061796.'}, {'pmid': '35468639', 'type': 'BACKGROUND', 'citation': 'Bestwick-Stevenson T, Toone R, Neupert E, Edwards K, Kluzek S. Assessment of Fatigue and Recovery in Sport: Narrative Review. Int J Sports Med. 2022 Dec;43(14):1151-1162. doi: 10.1055/a-1834-7177. Epub 2022 Apr 25.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': '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.'}, 'identificationModule': {'nctId': 'NCT06920966', 'briefTitle': 'Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Recovery Optimization Intervention to Reduce the Risk of Injuries in Soccer Players', 'orgStudyIdInfo': {'id': 'IGOID1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cold Water Immersion (CWI)', 'description': 'Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.', 'interventionNames': ['Other: Cold Water Immersion (CWI)']}, {'type': 'EXPERIMENTAL', 'label': 'Hot Water Immersion (HWI)', 'description': 'Participants undergo a continuous immersion of 18 minutes in hot water (38°C).', 'interventionNames': ['Other: Hot water immersion (HWI)']}, {'type': 'NO_INTERVENTION', 'label': 'No Immersion (NI)', 'description': 'Participants follow the same protocol structure without any immersion.'}, {'type': 'EXPERIMENTAL', 'label': 'Thermography-Guided Immersion (TI)', 'description': '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.', 'interventionNames': ['Other: Thermography-Guided Immersion (TI)']}], 'interventions': [{'name': 'Cold Water Immersion (CWI)', 'type': 'OTHER', 'otherNames': ['Intermittent Cold Water Immersion (11ºC)'], 'description': 'Participants undergo five intermittent immersions of 2 minutes each in cold water (11°C), with 2-minute rest periods in between.', 'armGroupLabels': ['Cold Water Immersion (CWI)']}, {'name': 'Hot water immersion (HWI)', 'type': 'OTHER', 'otherNames': ['Continuous hot water immersion (38ºC)'], 'description': 'Participants undergo a continuous immersion of 18 minutes in hot water (38°C)', 'armGroupLabels': ['Hot Water Immersion (HWI)']}, {'name': 'Thermography-Guided Immersion (TI)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Thermography-Guided Immersion (TI)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jose Luis Felipe, PhD', 'role': 'CONTACT', 'email': 'joseluis.felipe@uclm.es', 'phone': '+34648885392'}, {'name': 'Antonio Alonso, MsC', 'role': 'CONTACT', 'email': 'antonio.alonso@uclm.es', 'phone': '+34 615 45 09 89'}], 'overallOfficials': [{'name': 'Jose Luis Felipe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Castilla-La Mancha'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have decided not to share Individual Participant Data (IPD) with other researchers for several reasons:\n\nParticipant Privacy and Confidentiality: Protecting participant privacy is paramount. Sharing IPD, even de-identified, risks re-identification and breaches confidentiality.\n\nEthical Considerations: Our study involves sensitive health and performance data. Limiting access ensures responsible and ethical use, preventing misuse or misinterpretation.\n\nData Security: Sharing IPD requires robust security measures to prevent unauthorized access and breaches, which are complex and resource-intensive to maintain.\n\nInformed Consent: Our consent process did not include provisions for sharing IPD with external researchers. Sharing data without explicit consent would violate ethical approval and participant trust.\n\nResource Constraints: Managing data sharing requests and providing necessary support to external researchers require significant resources, which we currently lack.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}