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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Pharos University in Alexandria · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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. A 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)

Detailed description

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. Study Objective: To 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. Study Design: Randomized 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). Interventions: Group A - Hypoventilation Training: Moderate-intensity aerobic exercise on a cycle ergometer (40-60% HR reserve) Intermittent breath-holding: 5-10 seconds every 1-2 minutes Continuous monitoring of SpO₂, heart rate, and blood pressure Group B - Breathing Restriction Mask Training: Same aerobic protocol as Group A Participants wear an adjustable resistance mask to simulate hypoxia Mask set to induce mild hypoxemia (SpO₂ ≥85%) Continuous monitoring of SpO₂, heart rate, and blood pressure Group C - Control Group: Same aerobic exercise protocol under normal breathing conditions Moderate intensity (40-60% HR reserve) Periodic monitoring of vital signs for safety Intervention Duration: 12 weeks, 3 supervised sessions per week, 30 minutes per session Outcome Measures: Primary Outcome: Exercise tolerance assessed via 6-Minute Walk Test (6MWT) at baseline and post-intervention Secondary Outcomes: Fatigue: Fatigue Severity Scale (FSS), self-reported, 9 items, 7-point Likert scale Quality of Life: KDQOL-36, disease-specific questionnaire covering physical/mental health, symptoms, effects, and burden of CKD Cardiovascular Assessment: Blood pressure (SBP, DBP) and Heart Rate Recovery (HRR = HR\_peak - HR\_1min) Kidney Function: Serum creatinine and eGFR (CKD-EPI/MDRD

Conditions

• Chronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKD

Interventions

Type	Name	Description
BEHAVIORAL	hypoventilation group	Traditional Aerobic Training Participants will perform supervised aerobic exercise (e.g., cycling or treadmill walking) under controlled intermittent hypoxic conditions. Hypoxia 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. Frequency: 3 sessions per week for 12 weeks. Exercise intensity: Moderate (50-70% of heart rate reserve), adjusted individually based on baseline exercise testing

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-01-15
• Completion: 2026-02-01
• First posted: 2025-09-18
• Last updated: 2025-12-24