"Hypoxic vs. Aerobic Training in Chronic Kidney Disease

NCT07180875 | Not Yet Recruiting

• 1 other identifier: OlaElgohary-IHT-CKD-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

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

Outcome Measures

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.

  12 weeks

Secondary Outcomes (2)

• Fatigue Severity Scale (FSS)

  12 wwks

• Kidney Disease Quality of Life Questionnaire (KDQOL-36)

  12 weeks

Study Arms (3)

Hypoventilation Training group

EXPERIMENTAL

* Mode: Stationary cycling (ergometer). * Intensity: Moderate (40-60% VO₂max or Borg RPE 11-13). * Duration: 30 minutes per session. * Frequency: 3 sessions per week, for 12 weeks. * Technique: * Patients instructed to hold their breath (hypoventilation) for 5-10 seconds every 2-3 minutes during cycling. * Breathing then resumes normally until recovery. * Cycle repeated throughout the session

Behavioral: hypoventilation group

Breathing Restriction Mask Training

EXPERIMENTAL

* Mode: Stationary cycling (ergometer). * Intensity: Moderate (same as Group A: 40-60% VO₂max). * Duration: 30 minutes per session. * Frequency: 3 sessions per week, for 12 weeks. * Equipment: Commercially available breathing restriction mask (e.g., altitude simulation mask). * Technique: * Mask settings adjusted to provide increasing resistance over time, simulating hypoxic breathing (FiO₂ \~14-16%). * Patients cycle continuously with mask worn throughout the session. * Monitoring: * SpO₂, HR, BP monitored continuously. * Mask removed immediately if SpO₂ \< 88% or severe dyspnea occurs.

Behavioral: hypoventilation group

Control Group (Conventional Aerobic Training)

ACTIVE COMPARATOR

* Mode: Stationary cycling (ergometer). * 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. * No hypoventilation or mask used. * Monitoring: o HR, BP, and SpO₂ checked pre- and post-session. * Progression: * Workload (watts) increased every 2-3 weeks to maintain moderate intensity

Behavioral: hypoventilation group

Interventions

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

Also known as: Breathing Restriction Mask Training

Breathing Restriction Mask Training; Control Group (Conventional Aerobic Training); Hypoventilation Training group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Both men and women are eligible; no gender restriction
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable and cleared for exercise

You may not qualify if:

• Uncontrolled hypertension
• Severe cardiac arrhythmias
• Recent hospitalization (\<3 months)
• cardiovascular disese unstable

Sponsors & Collaborators

• Pharos University in Alexandria: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ola mohamed elgohary

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: December 9, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-09