Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

Aging Clinical Trial

— HYPOXAGE  

Official title:

Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048680
• Other study ID #: 38RC20.460
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2021
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: Stéphane Doutreleau, MD, PhD
• Phone: +33476767773
• Email: sdoutreleau[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Brain Diseases
• Cerebral Hypoxia
• Cognitive Decline
• Cognitive Dysfunction
• Exercise
• Healthy Aging
• Hypoxia
• Hypoxia, Brain

Intervention

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

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	La Tronche	Auvergne Rhône-Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Middle cerebral artery flow velocity	Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)	Before intervention; right after intervention; 2 months after intervention
Secondary	Peak oxygen uptake	Peak oxygen uptake during a cardiopulmonary exercise test	Before intervention; right after intervention; 2 months after intervention
Secondary	Flow-mediated dilation	Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery	Before intervention; right after intervention; 2 months after intervention
Secondary	Blood pressure	24h (systolic, diastolic and mean) blood pressure assessment	Before intervention; right after intervention; 2 months after intervention
Secondary	Sleep	Sleep features assessed by polygraphy	Before intervention; right after intervention; 2 months after intervention
Secondary	Cognitive function	Cognitive function assessed by the Montreal Cognitive Assessment questionnaire	Before intervention; right after intervention; 2 months after intervention
Secondary	Health-related quality of life	Health-related quality of life assessed by the SF-36 questionnaire	Before intervention; right after intervention; 2 months after intervention