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"Hypoxic vs. Aerobic Training in Chronic Kidney Disease

ConditionChronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorPharos University in Alexandria

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Medically stable and cleared for exercise

Disqualifiers

Uncontrolled hypertension

Severe cardiac arrhythmias

Recent hospitalization (<3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • hypoventilation group

    Behavioral

    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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Hypoventilation Training groupExperimental treatment 1 intervention
Group B: Breathing Restriction Mask TrainingExperimental treatment 1 intervention
Group C: Control Group (Conventional Aerobic Training)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 wwks
2

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/problems, effects, and burden of kidney disease). Scores are standardized (0-100), with higher scores indicating better quality of life

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharos University in Alexandria

Lead sponsor

Source ClinicalTrials.gov

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