[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659559":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":42,"interventions":57,"overallOfficials":33,"centralContacts":68,"locations":33,"responsibleParty":74,"collaborators":33,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":33,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":33,"enrollmentInfo":86,"targetDuration":33,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":97,"whyStopped":33,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":33},{"fullName":5,"class":6},"Ibadat International University, Islamabad","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":33},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Dialysis adequacy","Dialysis adequacy will be assessed using the Kt\u002FV value obtained through direct measurement from the dialyzer. Kt\u002FV is a measure of urea clearance during hemodialysis and will be used to evaluate the adequacy of dialysis treatment.","Baseline, Week 6, and Week 12.",{"measure":14,"description":15,"timeFrame":16},"Muscle Strength","Muscle strength will be assessed using an electronic hand dynamometer. Grip strength will be measured according to a standardized testing procedure.","Baseline, Week 6, and Week 12",{"measure":18,"description":19,"timeFrame":16},"Physical Functioning","Physical functioning will be assessed using the 6-Minute Walk Test. Participants will be instructed to walk for 6 minutes at their own maximal sustainable pace, and the total distance walked in meters will be recorded. Greater walking distance will indicate better functional exercise capacity.",[21,24,27,30],{"measure":22,"description":23,"timeFrame":16},"VO₂ Max","VO₂ max will be assessed using the 6-minute walk test. Participants will walk for 6 minutes on a 30-meter flat surface, and the total distance covered in six minutes will be recorded in meters. Heart rate and systolic blood pressure will be measured before and immediately after the test. Estimated peak oxygen uptake will be calculated using the validated Cahalin prediction equation.",{"measure":25,"description":26,"timeFrame":16},"Fatigue","Fatigue will be assessed objectively during the 6-Minute Walk Test (6MWT) by comparing the distance walked during the first and sixth minutes. The Walking Distance Index (DWI) will be calculated as DWI = \\[(distance walked during the sixth minute - distance walked during the first minute) \u002F distance walked during the first minute\\] × 100. More negative DWI values indicate greater decline in walking performance during the test and therefore greater walking-related performance fatigability.",{"measure":28,"description":29,"timeFrame":12},"Depression","Depressive symptoms will be assessed using the validated Urdu version of the Depression Anxiety Stress Scale-21 (DASS-21 Urdu). The depression subscale will be used to quantify the severity of depressive symptoms, with higher scores indicating greater symptom severity.",{"measure":31,"description":32,"timeFrame":12},"Health-related quality of life","Quality of life will be assessed using the Kidney Disease Quality of Life-36 questionnaire. The instrument assesses kidney disease-specific quality of life and the impact of kidney disease and its treatment on participants' physical and mental well-being. Scores will be calculated according to the instrument's scoring procedure, with higher scores indicating better health-related quality of life.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":40},"SINGLE",[41],"OUTCOMES_ASSESSOR",[43,49,53],{"label":44,"type":45,"description":46,"interventionNames":47},"Group A","EXPERIMENTAL","30-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 30-minute combined aerobic and resistance exercise program",[48],"Other: Combined Aerobic and Resistance Exercise",{"label":50,"type":45,"description":51,"interventionNames":52},"Group B","40-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 40-minute combined aerobic and resistance exercise program.",[48],{"label":54,"type":45,"description":55,"interventionNames":56},"Group C","Group C - 50-Minute Combined Aerobic and Resistance Exercise Participants in this group will receive a structured 50-minute combined aerobic and resistance exercise program.",[48],[58,62,65],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"Combined Aerobic and Resistance Exercise","Arm 1: Group A - 30-Minute Exercise Intervention Participants will receive a 30-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up (active ROM and deep breathing), 10 minutes of moderate-intensity stationary cycling (RPE 11-13), 10 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Resistance exercises will include upper- and lower-limb exercises using weight cuffs. Participants will perform 1 set of 10 repetitions per exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.",[44],{"type":6,"name":59,"description":63,"armGroupLabels":64,"otherNames":33},"Arm 2: Group B - 40-Minute Exercise Intervention Participants will receive a 40-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 15 minutes of moderate-intensity stationary cycling (RPE 11-13), 15 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 1 set of 15 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.",[50],{"type":6,"name":59,"description":66,"armGroupLabels":67,"otherNames":33},"Arm 3: Group C - 50-Minute Exercise Intervention Participants will receive a 50-minute combined aerobic and resistance exercise program. Each session will include 5 minutes of warm-up, 20 minutes of moderate-intensity stationary cycling (RPE 11-13), 20 minutes of resistance exercise at approximately 60% 1-RM, and 5 minutes of cool-down. Participants will perform 2 sets of 10 repetitions per resistance exercise, with 10-15 seconds of rest between exercises. Resistance will be progressed weekly according to 1-RM.",[54],[69],{"name":70,"role":71,"phone":72,"phoneExt":33,"email":73},"Somiya Naz, BSPT, PPDPT, PHD Scholar","CONTACT","923315163093","somiyanaz@uipt.iiui.edu.pk",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Somiya Naz","Assistant Professor","100659559","determination-of-optimal-exercise-duration-using-intradialytic-exercises-on-dialysis-adequacy-fatigue-depression-vo2-max-muscle-strength-physical-functioning-and-quality-of-life-in-patients-undergoing-hemodialysis-100659559",false,"NCT07865754","Determination of Optimal Exercise Duration Using Intradialytic Exercises on Dialysis Adequacy, Fatigue, Depression, VO2 Max, Muscle Strength, Physical Functioning, and Quality of Life in Patients Undergoing Hemodialysis","Inclusion Criteria:\n\n* Male and female patients aged above 18 years and willing to participate.\n* Diagnosed with ESRD, undergoing hemodialysis for at least three months, receiving hemodialysis three times per week.\n* Stable medical condition as determined by the treating nephrologist.\n* Able to participate in exercise sessions without contraindications.\n\nExclusion Criteria:\n\n* Unstable medical condition, such as recent cardiovascular events or respiratory failure.\n* Carcinoma\n* Pregnancy\n* Kidney transplant candidate\n* Hearing or visual impairments\n* Severe musculoskeletal impairments limiting exercise participation.\n* Cognitive impairment hindering comprehension and compliance.","ALL","18 Years",{"count":87,"type":88},120,"ESTIMATED","INTERVENTIONAL",[91],"NA","The purpose of this randomized controlled trial is to determine the optimal exercise duration of a combined exercise program (aerobic + resistance) in patients undergoing hemodialysis by evaluating its effects on dialysis adequacy, fatigue, depression, VO2 max, muscle strength, physical functioning, and QOL in patients undergoing hemodialysis.",[94],"Hemodialysis",[96],"Dialysis Adequacy, Fatigue, Hemodialysis, Intradialytic Exercises, Quality of life","NOT_YET_RECRUITING","2026-10-03",{"date":100,"type":101},"2026-10-08","ACTUAL",{"date":103,"type":88},"2026-10-15",{"date":105,"type":88},"2027-01-20",{"name":5,"class":6}]