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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Hypoxia; Exercise; Aging; Healthy Aging; Cognitive Decline; Cerebral Hypoxia
• Intervention / Treatment: Procedure: Hypoxia and/or Exercise

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samuel Vergès, PhD; Phone Number: +33476766860; Email: sverges@chu-grenoble.fr
• Study Contact Backup: Name: Stéphane Doutreleau, MD, PhD; Phone Number: +33476767773; Email: sdoutreleau@chu-grenoble.fr

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • La Tronche, Auvergne-Rhône-Alpes, France, 38700
      • Recruiting
      • Chu Grenoble Alpes
      • Contact: Samuel Vergès, PhD; Phone Number: +33476766860; Email: sverges@chu-grenoble.fr
      • Contact: Stéphane Doutreleau, MD, PhD; Phone Number: +33476767773; Email: sdoutreleau@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypoxia - Rest; Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.	Procedure: Hypoxia and/or Exercise; Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
Placebo Comparator: Normoxia - Rest; Sessions of normoxia at rest; 3 sessions/week; 8 weeks.	Procedure: Hypoxia and/or Exercise; Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
Experimental: Hypoxia - Exercise; Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.	Procedure: Hypoxia and/or Exercise; Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
Active Comparator: Normoxia - Exercise; Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks.	Procedure: Hypoxia and/or Exercise; Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake	Peak oxygen uptake during a cardiopulmonary exercise test	Before intervention; right after intervention; 2 months after intervention
Flow-mediated dilation	Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery	Before intervention; right after intervention; 2 months after intervention
Blood pressure	24h (systolic, diastolic and mean) blood pressure assessment	Before intervention; right after intervention; 2 months after intervention
Sleep	Sleep features assessed by polygraphy	Before intervention; right after intervention; 2 months after intervention
Cognitive function	Cognitive function assessed by the Montreal Cognitive Assessment questionnaire	Before intervention; right after intervention; 2 months after intervention
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Stéphane Doutreleau, MD, PhD, CHU Grenoble Alpes, Grenoble Alpes University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2021
• Primary Completion (Actual): March 17, 2024
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Cognitive Dysfunction; Hypoxia; Brain Diseases; Hypoxia, Brain; Motor Activity
• Other Study ID Numbers: 38RC20.460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan at this point in time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No