[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644198":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":53,"locations":59,"responsibleParty":82,"collaborators":38,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":38,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":38,"enrollmentInfo":96,"targetDuration":38,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":62,"whyStopped":38,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Universidad de Colima","OTHER",[8,14,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","consists of hemodialysis, intradialytic exercise, and creatine monohydrate.",[13],"Drug: Group A with creatine monohydrate",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","PLACEBO_COMPARATOR","consists of hemodialysis, intradialytic exercise, and placebo.",[19],"Other: Group B placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"Group C","ACTIVE_COMPARATOR","consists of hemodialysis and exercise.",[25],"Behavioral: Group C Intradialytic Exercise Program",{"label":27,"type":28,"description":29,"interventionNames":30},"Group D","SHAM_COMPARATOR","consists of hemodialysis.",[31],"Procedure: Comparison group D Hemodialysis",[33,39,43,48],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Group A with creatine monohydrate","Participants will receive 5 g of creatine monohydrate diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, supplementation will be administered immediately after the dialysis session. On non-dialysis days, supplementation will be administered after a meal.",[9],null,{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Group B placebo","Participants will receive 5 g of placebo diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, placebo will be administered immediately after the dialysis session. On non-dialysis days, placebo will be administered after a meal.",[15],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":38},"BEHAVIORAL","Group C Intradialytic Exercise Program","Participants will perform a supervised intradialytic exercise program during hemodialysis sessions for 8 weeks. The program will include aerobic and resistance exercises performed three times per week according to the study protocol.",[21],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":38},"PROCEDURE","Comparison group D Hemodialysis","Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.",[27],[54],{"name":55,"role":56,"phone":57,"phoneExt":38,"email":58},"Israel Pérez Palafox PALAFOX Master of Medical Sciences","CONTACT","+523151260402","iperez@ucol.mx",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"IMSS-Bienestar State Haemodialysis Centre","RECRUITING","Colima","Coliima","28048","Mexico","MX",{"type":69,"coordinates":70},"Point",[71,72],-103.7127,19.24473,{"lat":72,"lon":71},[75,79],{"name":76,"role":56,"phone":77,"phoneExt":38,"email":78},"Evalyn Ceballos Medica cirujana y partera","3121078792","eveceballoss@gmail.com",{"name":80,"role":81,"phone":38,"phoneExt":38,"email":38},"Pedro Julian Flores Moreno, Doctor of Medical Sciences","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Pedro Julian Flores Moreno","Ph.D. in Science","100644198","phase-1-intradialytic-exercise-combined-with-creatine-monohydrate-in-patients-with-chronic-kidney-disease-undergoing-hemodialysis-100644198",false,"NCT07666815","Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.","Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.","Inclusion Criteria:\n\n* atients who are treated at the State Haemodialysis Centre.\n\n  * Patients who receive haemodialysis three times a week.\n  * Signature of informed consent.\n  * Patients over 18 years of age, both men and women.\n  * Patients who have been on haemodialysis for no more than two years.\n\nExclusion Criteria:\n\nPatients who have had a limb amputated.\n\n* Patients who are in a state of anuria.\n* Inability to perform muscular resistance or aerobic resistance exercises.\n* Patients unable to perform physical exercise.\n* HIV-positive patients. Elimination.\n* Patients who voluntarily withdraw from the project.\n* Inability to perform physical exercise.\n* Death.\n* Adverse events related to creatine consumption.",true,"ALL","18 Years",{"count":97,"type":98},48,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.",[105],"Chronic Kidney Disease 5D",[107,108,109],"Creatine","Hemodialysis","Functionality","2026-06-18",{"date":112,"type":113},"2026-06-24","ACTUAL",{"date":115,"type":113},"2026-03-02",{"date":117,"type":98},"2026-08-07",{"name":84,"class":6},1]