Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

Обзор

In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.

Вмешательства

• Процедура Hypoxia and/or Exercise
  Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.

Первичные конечные точки

• Middle cerebral artery flow velocity [Срок оценки: Before intervention; right after intervention; 2 months after intervention]

Вторичные конечные точки (6)

• Peak oxygen uptake [Срок оценки: Before intervention; right after intervention; 2 months after intervention]
• Flow-mediated dilation [Срок оценки: Before intervention; right after intervention; 2 months after intervention]
• Blood pressure [Срок оценки: Before intervention; right after intervention; 2 months after intervention]
• Sleep [Срок оценки: Before intervention; right after intervention; 2 months after intervention]
• Cognitive function [Срок оценки: Before intervention; right after intervention; 2 months after intervention]
• Health-related quality of life [Срок оценки: Before intervention; right after intervention; 2 months after intervention]

Критерии участия

Критерии включения

• 60 to 80 years of age;
• Being physically inactive (less than 150 min/week of moderate to intense physical activity);
• No chronic cardiovascular, respiratory, metabolic or neuromuscular disease counterindicating an exercise training or hypoxic conditioning program;
• Health coverage;
• Being able to provide written fully informed consent.

Критерии исключения

• Body-mass index >30 kg/m2;
• Smoking (> cigarettes/day);
• Alcohol use (> 10g/day);
• Mental disorder or history of mental disorder;
• Beta-blockade treatment;
• Inability or refusal to provide informed consent;
• No health coverage
• People exceeding the annual ceiling of allowances received as a result of their participation in other clinical trials;
• People deprived of freedom by judicial or administrative decision;
• People subject to legal protection, who cannot be included in clinical trials.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHU Grenoble Alpes — La Tronche

Идентификаторы

NCT: NCT05048680 · 38RC20.460

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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