Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults

Официальное название

Acute Effects of a Hypoxia-hyperoxia Exposure Session on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, and Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial

Обзор

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%.

Вмешательства

• Устройство MITOVIT® 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
• Устройство Sham 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.

Первичные конечные точки

• Heart rate variability [Срок оценки: Immediately before intervention and immediately after intervention]

Вторичные конечные точки (2)

• Blood pressure [Срок оценки: Immediately before intervention and immediately after intervention]
• Arterial oxygen saturation [Срок оценки: Immediately before intervention and immediately after intervention]

Критерии участия

Критерии включения

• Being over 60 years old.
• Having no previous experience in hypoxic training.
• Engaging in less than 150 minutes of physical activity per week.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Residencial Montes de Toledo — Manzaneque

Идентификаторы

NCT: NCT06686238 · 015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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