Blood Pressure, Cardiovascular Health, Older Adults, Sedentary
Conditions
Keywords
hypoxic exposure, older adults, heart rate variability
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, and arterial oxygen saturation. The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, 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%.
Interventions
DEVICEMITOVIT® Hypoxic Training System
The EG (Experimental Group) will undergo a single session of IHHE (Intermittent Hypoxia-Hyperoxia Exposure) session using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). They will breathe air with an oxygen concentration (FiO2) ranging from 10-14% for 5 minutes, followed by 3 minutes of rest in hyperoxia (FiO2 30-40%), for a total of 6 cycles. During the hypoxic phase, oxygen saturation will be maintained between 85-92%, while during the hyperoxic phase, it will be kept above 95%. This process is regulated by the device's AI. Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the intervention
DEVICESham MITOVIT® Hypoxic Training System
The Sham Group (SG) will follow a single session protocol of 5 cycles of 6 minutes per session with an FiO2 of 21% using the MITOVIT® Hypoxic Training System (COMMIT GmbH, Salzgitter, Germany). Participants will be asked to sit and breath normally in each exposure. An attendance checklist will be used to monitor compliance with the placebo intervention.
Sponsors
Universidad Europea de Madrid
Sierra Varona SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Being over 60 years old. * Having no previous experience in hypoxic training. * Engaging in less than 150 minutes of physical activity per week.
Exclusion criteria
* Having any pathology that prevents the subject from being independent in terms of walking and functionality. * Subjects with impaired cognitive abilities. * Subjects with pulmonary hypertension, decompensated heart or respiratory disease. * To have or have had cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | Immediately before intervention and immediately after intervention | The analysis of Heart Rate Variability will be conducted using a heart rate monitor. Cardiac electrical signals will be monitored with a band placed on the chest for 5 minutes with the subject in supine position on a stretcher, in a quiet environment, soft light, and a comfortable temperature. Subjects are instructed not to speak or make voluntary movements during this analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Immediately before intervention and immediately after intervention | Both systolic and diastolic blood pressure will be assesed using a standard digital sphygmomanometer (Omron HEM-705CP, Omron Healthcare, Inc, Lake Forest, IL) |
| Arterial oxygen saturation | Immediately before intervention and immediately after intervention | Arterial oxygen saturation will be assessed using a device Nonin® 3230 (Nonin Medical, Inc. Plymouth, MN, EEUU) |
Countries
Spain
Contacts
Primary ContactArturo Ladriñán
Outcome results
None listed