Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly (HYPOXAGE)

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Aging; Cognitive Decline; Cerebral Hypoxia; Hypoxia; Healthy Aging; Exercise; Brain Diseases

Treatments: Procedure: Hypoxia and/or Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05048680

38RC20.460

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

Hypoxia - Rest

Experimental group

Description:

Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.

Treatment:

Procedure: Hypoxia and/or Exercise

Normoxia - Rest

Placebo Comparator group

Description:

Sessions of normoxia at rest; 3 sessions/week; 8 weeks.

Treatment:

Procedure: Hypoxia and/or Exercise

Hypoxia - Exercise

Experimental group

Description:

Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.

Treatment:

Procedure: Hypoxia and/or Exercise

Normoxia - Exercise

Active Comparator group

Description:

Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks.

Treatment:

Procedure: Hypoxia and/or Exercise