Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT03155633
Status:
COMPLETED
Last Update Posted:
2017-05-16
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable")
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The first one performed rests during the 9 days after the race, the second performed continuous race monitored every 48h from the end of the race, and the third group performed aerobic work on an elliptical machine under the same conditions as the group of Continuous race'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-15', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Blood Physiological parameters', 'timeFrame': 'baseline, 0, 24, 48, 96, 144 and 192 hours post-race', 'description': 'Blood test'}, {'measure': 'Analysis of tne changes in the Physical activity data', 'timeFrame': 'One month before the pre-race, accelerometers were worn during seven days. Accelerometers were also worn during nine days starting from the night before the marathon race', 'description': 'Physical activity measured by wearing accelerometer devices. Physical activity defined as sedentary, light, moderate and vigorous. The aim to wear accelerometers devices is to monitor individuals during recovery time post-marathon race'}, {'measure': 'Change in the Urin Physiological parameters', 'timeFrame': 'baseline, 0, 48, 96, 144 and 192 hours post-race', 'description': 'Urin test'}], 'secondaryOutcomes': [{'measure': 'Self-reported questionnaire', 'timeFrame': 'One month before the race day', 'description': 'Personal questionnaire asking for social and training habits'}, {'measure': 'Strength level', 'timeFrame': 'pre-marathon race and 0, 48, 96, 144 hours post-marathon race', 'description': 'Squat Jump (cm). Two jumps per person'}, {'measure': 'Analysis of the change of body mass index', 'timeFrame': 'one month before the marathon race day, 24 hours before the marathon race, 2 hours before the marathon race and 10 minutes after the marathon race', 'description': 'BMI'}, {'measure': 'Physical Condition', 'timeFrame': 'One month before the marathon race day', 'description': 'Maximal oxygen consumption'}, {'measure': 'Body composition', 'timeFrame': 'One month before the marathon race day', 'description': 'Bioimpedance analysis'}, {'measure': 'Heart rate', 'timeFrame': 'Through marathon completion, an average of 4 hours', 'description': 'Recording the number of contractions of the heart per minute (bpm) by using a heart rate monitor during all the marathon race'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marathon, runners, biomarkers, recovery'], 'conditions': ['Physical Exertion']}, 'referencesModule': {'references': [{'pmid': '28052642', 'type': 'BACKGROUND', 'citation': "Knechtle B, Nikolaidis PT, Zingg MA, Rosemann T, Rust CA. Differences in age of peak marathon performance between mountain and city marathon running - The 'Jungfrau Marathon' in Switzerland. Chin J Physiol. 2017 Feb 28;60(1):11-22. doi: 10.4077/CJP.2017.BAE400."}, {'pmid': '28382580', 'type': 'BACKGROUND', 'citation': 'Roca E, Nescolarde L, Lupon J, Barallat J, Januzzi JL, Liu P, Cruz Pastor M, Bayes-Genis A. The Dynamics of Cardiovascular Biomarkers in non-Elite Marathon Runners. J Cardiovasc Transl Res. 2017 Apr;10(2):206-208. doi: 10.1007/s12265-017-9744-2. Epub 2017 Apr 5.'}, {'pmid': '27911915', 'type': 'BACKGROUND', 'citation': 'Santos VC, Sierra AP, Oliveira R, Cacula KG, Momesso CM, Sato FT, Silva MB, Oliveira HH, Passos ME, de Souza DR, Gondim OS, Benetti M, Levada-Pires AC, Ghorayeb N, Kiss MA, Gorjao R, Pithon-Curi TC, Cury-Boaventura MF. Marathon Race Affects Neutrophil Surface Molecules: Role of Inflammatory Mediators. PLoS One. 2016 Dec 2;11(12):e0166687. doi: 10.1371/journal.pone.0166687. eCollection 2016.'}, {'pmid': '27609306', 'type': 'BACKGROUND', 'citation': 'Niemela M, Kangastupa P, Niemela O, Bloigu R, Juvonen T. Individual responses in biomarkers of health after marathon and half-marathon running: is age a factor in troponin changes? Scand J Clin Lab Invest. 2016 Nov;76(7):575-580. doi: 10.1080/00365513.2016.1225122. Epub 2016 Sep 9.'}, {'pmid': '26073606', 'type': 'BACKGROUND', 'citation': 'Kim YJ, Ahn JK, Shin KA, Kim CH, Lee YH, Park KM. Correlation of Cardiac Markers and Biomarkers With Blood Pressure of Middle-Aged Marathon Runners. J Clin Hypertens (Greenwich). 2015 Nov;17(11):868-73. doi: 10.1111/jch.12591. Epub 2015 Jun 13.'}, {'pmid': '25665742', 'type': 'BACKGROUND', 'citation': 'Tojima M, Noma K, Torii S. Changes in serum creatine kinase, leg muscle tightness, and delayed onset muscle soreness after a full marathon race. J Sports Med Phys Fitness. 2016 Jun;56(6):782-8. Epub 2015 Feb 10.'}, {'pmid': '21642857', 'type': 'BACKGROUND', 'citation': 'Knechtle B, Knechtle P, Rosemann T, Lepers R. Personal best marathon time and longest training run, not anthropometry, predict performance in recreational 24-hour ultrarunners. J Strength Cond Res. 2011 Aug;25(8):2212-8. doi: 10.1519/JSC.0b013e3181f6b0c7.'}, {'pmid': '21484048', 'type': 'BACKGROUND', 'citation': 'Knechtle B, Knechtle P, Barandun U, Rosemann T, Lepers R. Predictor variables for half marathon race time in recreational female runners. Clinics (Sao Paulo). 2011;66(2):287-91. doi: 10.1590/s1807-59322011000200018.'}, {'pmid': '32796418', 'type': 'DERIVED', 'citation': 'Martinez-Navarro I, Montoya-Vieco A, Collado E, Hernando B, Panizo N, Hernando C. Muscle Cramping in the Marathon: Dehydration and Electrolyte Depletion vs. Muscle Damage. J Strength Cond Res. 2022 Jun 1;36(6):1629-1635. doi: 10.1519/JSC.0000000000003713. Epub 2020 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'This study has as main objective to know how the processes of recovery are realized after a race of marathon. For this, the participants of a marathon race are divided into three work groups during the 9 days post-marathon, one with rest in the recovery period, another with continuous race three sessions every 48h and another with three sessions of elliptical every 48h .', 'detailedDescription': 'The marathon runners suffer a high fatigue, as has been studied by different investigations, the proposal of this study is to know how the recovery processes are produced in runners who have completed a 42km test.\n\nTo do this, baseline measurements of the runners have been made through stress tests and determinations of biomarkers in blood and urine. Subsequently blood and urine samples were taken the day before the marathon test and blood and urine samples were then taken again on arrival at 24h, 48h, 96h, 144h, and 196h.\n\nAt the same time, an intervention was carried out in the recovery phase, with the runners in three groups. The first one performed rests during the 9 days after the race, the second performed continuous race monitored every 48h from the end of the race, and the third group performed aerobic work on an elliptical machine under the same conditions as the group of Continuous race'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults healthy with 30-45 years\n* BMI between 16-24,99\n* Time in marathon between 3h-4h in men\n* Time in marathon between 3h:30min-4h:40min in women\n\nExclusion Criteria:\n\n* Having heart disease\n* Having kidney disease\n* Taking a medication on an ongoing basis'}, 'identificationModule': {'nctId': 'NCT03155633', 'acronym': 'CRS', 'briefTitle': 'Run, Recovery, Repeat, Always Healthy ("Corre, Recupera, Repite, Siempre Saludable")', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Jaume I'}, 'officialTitle': '"Corre, Recupera, Repite, Siempre Saludable".', 'orgStudyIdInfo': {'id': 'UJI_CRS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Rest Group', 'description': 'Rest during the 9 days after the race'}, {'type': 'EXPERIMENTAL', 'label': 'Running Group', 'description': 'Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices', 'interventionNames': ['Other: Athletics track']}, {'type': 'EXPERIMENTAL', 'label': 'Elliptical Group', 'description': 'Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices', 'interventionNames': ['Other: Elliptical machine']}], 'interventions': [{'name': 'Athletics track', 'type': 'OTHER', 'description': 'Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices', 'armGroupLabels': ['Running Group']}, {'name': 'Elliptical machine', 'type': 'OTHER', 'description': 'Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices', 'armGroupLabels': ['Elliptical Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carlos Hernando', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitat Jaume I'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data are administered by the Investigator Principal, other researchers must request the data they need by written request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Jaume I', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Trinidad Alfonso', 'class': 'UNKNOWN'}, {'name': 'Fundación Hospitales NISA', 'class': 'UNKNOWN'}, {'name': 'SD. Correcaminos', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph D. Director of Sports Service', 'investigatorFullName': 'Carlos Hernando', 'investigatorAffiliation': 'Universitat Jaume I'}}}}