Simulated Hypoxia Training to Enhance Exercise Tolerance in Stage 3 Chronic Kidney Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Six-Minute Walk Test (6MWT) distance
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (40-65 years) diagnosed with CKD stages 3a,b
- •Medically stable and cleared for exercise
排除标准
- •Uncontrolled hypertension
- •Severe cardiac arrhythmias
- •Recent hospitalization (<3 months)
- •cardiovascular disese unstable
研究组 & 干预措施
Hypoventilation Training group
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Mode: Stationary cycling (ergometer).
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Intensity: Moderate (40-60% VO₂max or Borg RPE 11-13).
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Duration: 30 minutes per session.
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Frequency: 3 sessions per week, for 12 weeks.
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Technique:
-
Patients instructed to hold their breath (hypoventilation) for 5-10 seconds every 2-3 minutes during cycling.
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Breathing then resumes normally until recovery.
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Cycle repeated throughout the session
干预措施: hypoventilation group (Behavioral)
Breathing Restriction Mask Training
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Mode: Stationary cycling (ergometer).
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Intensity: Moderate (same as Group A: 40-60% VO₂max).
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Duration: 30 minutes per session.
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Frequency: 3 sessions per week, for 12 weeks.
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Equipment: Commercially available breathing restriction mask (e.g., altitude simulation mask).
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Technique:
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Mask settings adjusted to provide increasing resistance over time, simulating hypoxic breathing (FiO₂ ~14-16%).
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Patients cycle continuously with mask worn throughout the session.
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Monitoring:
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SpO₂, HR, BP monitored continuously.
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Mask removed immediately if SpO₂ < 88% or severe dyspnea occurs.
干预措施: hypoventilation group (Behavioral)
Control Group (Conventional Aerobic Training)
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Mode: Stationary cycling (ergometer).
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Intensity: Moderate (40-60% VO₂max or Borg RPE 11-13).
-
Duration: 30 minutes per session.
-
Frequency: 3 sessions per week, for 12 weeks.
-
Technique:
-
Continuous cycling at steady pace.
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No hypoventilation or mask used.
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Monitoring:
o HR, BP, and SpO₂ checked pre- and post-session.
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Progression:
-
Workload (watts) increased every 2-3 weeks to maintain moderate intensity
干预措施: hypoventilation group (Behavioral)
结局指标
主要结局
Six-Minute Walk Test (6MWT) distance
时间窗: 12 weeks
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.
Six-Minute Walk Test (6MWT) distance
时间窗: 12 weeks
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.
次要结局
- Fatigue Severity Scale (FSS)(12 wwks)
- Kidney Disease Quality of Life Questionnaire (KDQOL-36)(12 weeks)
- Fatigue Severity Scale (FSS)(12 wwks)
- Kidney Disease Quality of Life Questionnaire (KDQOL-36)(12 weeks)
研究者
Ola Mohamed Elsayed Elgohary
ola mohamed elgohary
Pharos University in Alexandria