Clinical trial NCT06686316: Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
Official title: Effects of a 6-week Hypoxia-hyperoxia Exposure Protocol on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, Respiratory Muscle Strength, Pulmonary Function, Inflammatory Biomarkers and Arterial Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Frailty
Older Adults
Keywords: hypoxic training
elderly
heart rate variability
Lead sponsor: Sierra Varona SL
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2024-11-13
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, inflammatory biomarkers, 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 sham group will undergo a 5-cycle protocol with an FiO2 of 21%.

Both groups will follow a 6-week protocol with three weekly sessions (Monday, Wednesday, and Friday).


Eligibility criteria: Inclusion Criteria:

* Being over 65 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

Primary outcomes:
measure: Heart rate variability
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
measure: Arterial oxygen saturation
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
measure: Respiratory muscle strength
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
measure: Pulmonary function
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
measure: Inflammatory biomarkers
timeFrame: 24 hours before intervention and 24 hours after 6 week intervention
Other outcomes:
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