Clinical trial NCT05048680: Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Official title: Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxia
Cerebral Hypoxia
Brain Diseases
Exercise
Aging
Cognitive Decline
Healthy Aging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Middle cerebral artery flow velocity
timeFrame: Before intervention; right after intervention; 2 months after intervention
Secondary outcomes:
measure: Peak oxygen uptake
timeFrame: Before intervention; right after intervention; 2 months after intervention
measure: Flow-mediated dilation
timeFrame: Before intervention; right after intervention; 2 months after intervention
measure: Blood pressure
timeFrame: Before intervention; right after intervention; 2 months after intervention
measure: Sleep
timeFrame: Before intervention; right after intervention; 2 months after intervention
measure: Cognitive function
timeFrame: Before intervention; right after intervention; 2 months after intervention
measure: Health-related quality of life
timeFrame: Before intervention; right after intervention; 2 months after intervention
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU Grenoble Alpes
state: Auvergne Rhône-Alpes
Study officials:
affiliation: CHU Grenoble Alpes, Grenoble Alpes University
name: Stéphane Doutreleau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: