"Hypoxic vs. Aerobic Training in Chronic Kidney Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: hypoventilation group.
- Кому может быть актуально
- Состояния в реестре: Chronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKD. Базовые параметры: 40 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Simulated Hypoxia Training to Enhance Exercise Tolerance in Stage 3 Chronic Kidney Disease: A Randomized Controlled Trial
Обзор
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)
Подробное описание
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
Вмешательства
- Поведенческое 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 tes
Первичные конечные точки
- Six-Minute Walk Test (6MWT) distance [Срок оценки: 12 weeks]
Вторичные конечные точки (2)
- Fatigue Severity Scale (FSS) [Срок оценки: 12 wwks]
- Kidney Disease Quality of Life Questionnaire (KDQOL-36) [Срок оценки: 12 weeks]
Критерии участия
Inclusion Criteria:Adults (40-65 years) diagnosed with CKD stages 3a,b
- Medically stable and cleared for exercise
Критерии исключения
- Uncontrolled hypertension
- Severe cardiac arrhythmias
- Recent hospitalization (<3 months)
cardiovascular disese unstable
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07180875 · OlaElgohary-IHT-CKD-01