[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656014":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":64,"studyPopulation":64,"armGroups":71,"interventions":87,"overallOfficials":64,"centralContacts":97,"locations":103,"responsibleParty":122,"collaborators":124,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":131,"sex":137,"minAge":138,"maxAge":64,"enrollmentInfo":139,"targetDuration":64,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":106,"whyStopped":64,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Ricerca Nefrocenter","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":64},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of intradialytic intolerance and hemodynamic instability","Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.","Baseline to 6 months",[14,17,21,24,27,30,34,37,40,43,46,49,52,55,58,61],{"measure":15,"description":16,"timeFrame":12},"Maximal workload during cycle ergometer stress testing","Changes in maximal workload achieved during cycle ergometer stress testing.",{"measure":18,"description":19,"timeFrame":20},"Six-minute walk test distance","Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.","Baseline and 6 months",{"measure":22,"description":23,"timeFrame":20},"Step-test performance","Changes in step-test performance as an indicator of functional mobility and lower-limb performance.",{"measure":25,"description":26,"timeFrame":20},"Chair-stand test performance","Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.",{"measure":28,"description":29,"timeFrame":20},"Handgrip strength","Changes in handgrip strength measured using a hand dynamometer.",{"measure":31,"description":32,"timeFrame":33},"Weekly exercise time","Changes in the total amount of exercise completed per week during the intervention period.","Throughout the 6-month intervention period",{"measure":35,"description":36,"timeFrame":12},"Fat-free mass and fat mass","Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.",{"measure":38,"description":39,"timeFrame":20},"Bone mineral content","Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).",{"measure":41,"description":42,"timeFrame":20},"Bone mineral status (T-score)","Changes in T-score as an indicator of bone mineral status.",{"measure":44,"description":45,"timeFrame":20},"Appendicular skeletal muscle mass index (ASMMI)","Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.",{"measure":47,"description":48,"timeFrame":20},"Anthropometric circumferences","Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.",{"measure":50,"description":51,"timeFrame":12},"Health-related quality of life","Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire. The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.",{"measure":53,"description":54,"timeFrame":12},"Medication burden","Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.",{"measure":56,"description":57,"timeFrame":12},"Dialysis adequacy","Changes in dialysis adequacy expressed as Kt\u002FV.",{"measure":59,"description":60,"timeFrame":20},"Dialysis session duration","Changes in the duration of the hemodialysis session (min).",{"measure":62,"description":63,"timeFrame":20},"Blood flow rate","Changes in blood flow rate (Qb) during hemodialysis.",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":70,"maskingDescription":64,"whoMasked":64},"NONE",[72,78,83],{"label":73,"type":74,"description":75,"interventionNames":76},"Cycle ergometer","ACTIVE_COMPARATOR","Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13. Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.",[77],"Behavioral: Intradialytic aerobic exercise using a cycle ergometer",{"label":79,"type":74,"description":80,"interventionNames":81},"Elastic band resistance training","Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance was progressively adjusted according to individual tolerance and correct exercise execution. Sessions were supervised by exercise professionals and monitored by dialysis nurses.",[82],"Behavioral: Intradialytic elastic-band resistance exercise",{"label":84,"type":85,"description":86,"interventionNames":64},"Control","NO_INTERVENTION","Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program. Clinical assessments and follow-up evaluations were performed according to the study protocol.",[88,93],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":64},"BEHAVIORAL","Intradialytic aerobic exercise using a cycle ergometer","Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13). Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.",[73],{"type":89,"name":94,"description":95,"armGroupLabels":96,"otherNames":64},"Intradialytic elastic-band resistance exercise","Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.",[79],[98],{"name":99,"role":100,"phone":101,"phoneExt":64,"email":102},"Ersilia Satta, PhD MD","CONTACT","+39 3395703091","e.satta@consorzionefrocenter.it",[104],{"facility":105,"status":106,"city":107,"state":64,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"NefroCenter Dialysis Centers","RECRUITING","Torre del Greco","80059","Italy","IT",{"type":112,"coordinates":113},"Point",[114,115],14.36806,40.78931,{"lat":115,"lon":114},[118,120],{"name":119,"role":100,"phone":101,"phoneExt":64,"email":102},"Study Coordinator, PhD",{"name":99,"role":121,"phone":64,"phoneExt":64,"email":64},"PRINCIPAL_INVESTIGATOR",{"type":123,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR",[125,127],{"name":126,"class":6},"University of Naples",{"name":128,"class":6},"Federico II University","100656014","physical-exercise-in-patients-with-chronic-kidney-disease-in-hemodialysis-pehedal-eskd-100656014",false,"NCT07820514","Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD)","Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease","Pehedal-ESKD","Inclusion Criteria:\n\n* Age ≥18 years.\n* Receiving maintenance hemodialysis for more than 3 months.\n* Clinically stable condition.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Unstable angina.\n* Uncontrolled hypertension.\n* Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe","ALL","18 Years",{"count":140,"type":141},312,"ESTIMATED","INTERVENTIONAL",[144],"NA","The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:\n\n* Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?\n* Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?\n\nResearchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.\n\nParticipants will:\n\n* Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.\n* Attend hemodialysis sessions as scheduled.\n* Complete physical performance and body composition assessments at baseline and after 6 months.\n* Complete questionnaires about health and quality of life.\n\nThe results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.",[147,148],"Chronic Kidney Disease on Hemodialysis","Physical Exercise Behavior (Liking\u002FAversion)",[150,151,152,153,154,155],"hemodialysis","intradialytic exercise","aerobic training","resistance training","sarcopenia","quality of life","2026-09-14",{"date":158,"type":159},"2026-09-15","ACTUAL",{"date":161,"type":159},"2024-06-01",{"date":163,"type":141},"2027-03-01",{"name":5,"class":6},1]