None listed
Conditions
Brief summary
The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation. According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, arterial oxygen saturation and inflamatory biomarkers. The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo a 6-weeks IHHE protocol, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21% during 6 weeks. The sessions per patient will be conducted with a 48-hour interval between each one in both groups.
Interventions
The Experimental Group (EG) will undergo a 6-week intervention, involving alternate sessions of Intermittent Hypoxic Hyperoxic Exposure (IHHE) using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). Participants will breathe air with an oxygen concentration (FiO2) between 10-14% for 1-5 minutes, followed by 1-3 minutes of hyperoxia (FiO2 30-40%), totaling 4-8 cycles. The number of cycles will be based on the individual's acute response to hypoxia.
The sessions
The Experimental Group (EG) will undergo a 6-week intervention, involving alternate sessions of Intermittent Hypoxic Hyperoxic Exposure (IHHE) using the Energy/iAltitude® device (iAltitude Training S.L., Fuenlabrada, Madrid, Spain). Participants will breathe air with an oxygen concentration (FiO2) between 10-14% for 1-5 minutes, followed by 1-3 minutes of hyperoxia (FiO2 30-40%), totaling 4-8 cycles. The number of cycles will be based on the individual's acute response to hypoxia. The sessions per patient will be conducted with a 48-hour interval between each one in both groups. Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the intervention
Sponsors
Universidad Europea de Madrid
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
60 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
• Being over 60 years old. • Having no previous experience in hypoxic training
Exclusion criteria
• Having any pathology that prevents the performance of physical activity. • Subjects with impaired cognitive abilities. • Subjects with pulmonary hypertension, decompensated heart or respiratory failure. • Subjects who have undergone lower limb surgery within the past 12 months.
Outcome results
None listed