[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606847":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":31,"studyPopulation":21,"armGroups":32,"interventions":48,"overallOfficials":21,"centralContacts":21,"locations":21,"responsibleParty":55,"collaborators":21,"id":59,"slug":21,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":21,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":21,"overallStatus":79,"whyStopped":21,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":21},{"fullName":5,"class":6},"Pharos University in Alexandria","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Six-Minute Walk Test (6MWT) distance","Straightforward standardized 6-minute corridor walk performed according to ATS guidelines. Participants walk back and forth along a marked 30-meter course for 6 minutes; standardized instructions and encouragement are given. Total distance walked (meters) recorded. Assessors are blinded to group allocation.","12 weeks",[14,18],{"measure":15,"description":16,"timeFrame":17},"Fatigue Severity Scale (FSS)","A validated 9-item self-report questionnaire assessing the impact and severity of fatigue on daily functioning. Each item is rated on a 7-point Likert scale; higher scores indicate greater fatigue.","12 wwks",{"measure":19,"description":20,"timeFrame":12},"Kidney Disease Quality of Life Questionnaire (KDQOL-36)","A disease-specific quality of life tool combining general health status (SF-12) and kidney disease-targeted domains (symptoms\u002Fproblems, effects, and burden of kidney disease). Scores are standardized (0-100), with higher scores indicating better quality of life",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":28,"whoMasked":29},"SINGLE","Masking Description: Outcome assessors and data analysts will be blinded to group allocation; participants and trainers cannot be blinded due to the nature of the intervention",[30],"PARTICIPANT","Chronic kidney disease (CKD) stage 3 is characterized by reduced exercise capacity, muscle weakness, and increased cardiovascular risk, which negatively impact quality of life. Exercise interventions have shown benefits in improving functional outcomes, but traditional aerobic training may be limited due to comorbidities and reduced physiological reserve. Intermittent hypoxic training (IHT) improves oxygen utilization, cardiovascular adaptation, and mitochondrial function. Specialized hypoxicator devices are costly and not widely available, so practical alternatives such as hypoventilation training and breathing restriction masks may provide comparable benefits.\n\nStudy Objective:\n\nTo evaluate the effects of hypoventilation training and breathing restriction mask training on exercise tolerance, cardiovascular function, kidney function, fatigue, and quality of life in CKD stage 3 patients.\n\nStudy Design:\n\nRandomized controlled trial including 60 patients with CKD stage 3, aged 40-65 years, recruited from outpatient clinics at Aboker Hospital and Pharos University. Participants will be screened for eligibility through medical history, vital signs, and laboratory tests (serum creatinine, eGFR, hemoglobin, electrolytes).\n\nInterventions:\n\nGroup A - Hypoventilation Training:\n\nModerate-intensity aerobic exercise on a cycle ergometer (40-60% HR reserve)\n\nIntermittent breath-holding: 5-10 seconds every 1-2 minutes\n\nContinuous monitoring of SpO₂, heart rate, and blood pressure\n\nGroup B - Breathing Restriction Mask Training:\n\nSame aerobic protocol as Group A\n\nParticipants wear an adjustable resistance mask to simulate hypoxia\n\nMask set to induce mild hypoxemia (SpO₂ ≥85%)\n\nContinuous monitoring of SpO₂, heart rate, and blood pressure\n\nGroup C - Control Group:\n\nSame aerobic exercise protocol under normal breathing conditions\n\nModerate intensity (40-60% HR reserve)\n\nPeriodic monitoring of vital signs for safety\n\nIntervention Duration:\n\n12 weeks, 3 supervised sessions per week, 30 minutes per session\n\nOutcome Measures:\n\nPrimary Outcome:\n\nExercise tolerance assessed via 6-Minute Walk Test (6MWT) at baseline and post-intervention\n\nSecondary Outcomes:\n\nFatigue: Fatigue Severity Scale (FSS), self-reported, 9 items, 7-point Likert scale\n\nQuality of Life: KDQOL-36, disease-specific questionnaire covering physical\u002Fmental health, symptoms, effects, and burden of CKD\n\nCardiovascular Assessment: Blood pressure (SBP, DBP) and Heart Rate Recovery (HRR = HR\\_peak - HR\\_1min)\n\nKidney Function: Serum creatinine and eGFR (CKD-EPI\u002FMDRD",[33,39,43],{"label":34,"type":35,"description":36,"interventionNames":37},"Hypoventilation Training group","EXPERIMENTAL","* Mode: Stationary cycling (ergometer).\n* Intensity: Moderate (40-60% VO₂max or Borg RPE 11-13).\n* Duration: 30 minutes per session.\n* Frequency: 3 sessions per week, for 12 weeks.\n* Technique:\n\n  * Patients instructed to hold their breath (hypoventilation) for 5-10 seconds every 2-3 minutes during cycling.\n  * Breathing then resumes normally until recovery.\n  * Cycle repeated throughout the session",[38],"Behavioral: hypoventilation group",{"label":40,"type":35,"description":41,"interventionNames":42},"Breathing Restriction Mask Training","* Mode: Stationary cycling (ergometer).\n* Intensity: Moderate (same as Group A: 40-60% VO₂max).\n* Duration: 30 minutes per session.\n* Frequency: 3 sessions per week, for 12 weeks.\n* Equipment: Commercially available breathing restriction mask (e.g., altitude simulation mask).\n* Technique:\n\n  * Mask settings adjusted to provide increasing resistance over time, simulating hypoxic breathing (FiO₂ \\~14-16%).\n  * Patients cycle continuously with mask worn throughout the session.\n* Monitoring:\n\n  * SpO₂, HR, BP monitored continuously.\n  * Mask removed immediately if SpO₂ \\\u003C 88% or severe dyspnea occurs.",[38],{"label":44,"type":45,"description":46,"interventionNames":47},"Control Group (Conventional Aerobic Training)","ACTIVE_COMPARATOR","* Mode: Stationary cycling (ergometer).\n* Intensity: Moderate (40-60% VO₂max or Borg RPE 11-13).\n* Duration: 30 minutes per session.\n* Frequency: 3 sessions per week, for 12 weeks.\n* Technique:\n\n  * Continuous cycling at steady pace.\n  * No hypoventilation or mask used.\n* Monitoring:\n\n  o HR, BP, and SpO₂ checked pre- and post-session.\n* Progression:\n\n  * Workload (watts) increased every 2-3 weeks to maintain moderate intensity",[38],[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"BEHAVIORAL","hypoventilation group","Traditional Aerobic Training Participants will perform supervised aerobic exercise (e.g., cycling or treadmill walking) under controlled intermittent hypoxic conditions.\n\nHypoxia protocol: alternating cycles of low-oxygen exposure (FiO₂ 12-16%) for 3-5 minutes followed by normoxic recovery for 2-3 minutes, repeated 6-8 times per session.\n\nFrequency: 3 sessions per week for 12 weeks.\n\nExercise intensity: Moderate (50-70% of heart rate reserve), adjusted individually based on baseline exercise testing",[40,44,34],[40],{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Ola Mohamed Elsayed Elgohary","ola mohamed elgohary","100606847",false,"NCT07180875","\"Hypoxic vs. Aerobic Training in Chronic Kidney Disease","Simulated Hypoxia Training to Enhance Exercise Tolerance in Stage 3 Chronic Kidney Disease: A Randomized Controlled Trial","IHT-CKD","Inclusion Criteria:Adults (40-65 years) diagnosed with CKD stages 3a,b\n\n* Medically stable and cleared for exercise\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Severe cardiac arrhythmias\n* Recent hospitalization (\\\u003C3 months)\n\ncardiovascular disese unstable",true,"ALL","40 Years","65 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","Chronic kidney disease (CKD) leads to poor exercise tolerance, vascular dysfunction, and reduced quality of life. This randomized controlled trial will compare intermittent hypoxic training (IHT) with traditional aerobic training in patients with CKD stages 3-4.\n\nA total of 60 participants aged 40-65 years will be recruited and randomized into three groups. Interventions will last 12 weeks, with three 30-minute supervised sessions per week. Outcome measures include exercise tolerance (6-Minute Walk Test), cardiovascular parameters (blood pressure, heart rate recovery), kidney function (serum creatinine, eGFR), fatigue (Fatigue Severity Scale), and quality of life (KDQOL-36)",[78],"Chronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance \u002F Functional Capacity Vascular Health \u002F Arterial Stiffness Fatigue in CKD","NOT_YET_RECRUITING","2025-12-18",{"date":82,"type":83},"2025-12-24","ACTUAL",{"date":85,"type":72},"2025-12-09",{"date":87,"type":72},"2026-02-01",{"name":5,"class":6}]