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NCT Number: NCT05048680

Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

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.

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Key information

Conditions

Hypoxia Aging Behavior Brain Diseases Central Nervous System Diseases Cerebral Hypoxia Cognition Disorders Cognitive Decline Cognitive Dysfunction Exercise Healthy Aging Hypoxia, Brain Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypoxia and/or Exercise

Procedure

Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.

Primary outcomes

  1. Middle cerebral artery flow velocity

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)

Secondary outcomes

  1. Peak oxygen uptake

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Peak oxygen uptake during a cardiopulmonary exercise test

  2. Flow-mediated dilation

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery

  3. Blood pressure

    Time frame: Before intervention; right after intervention; 2 months after intervention

    24h (systolic, diastolic and mean) blood pressure assessment

  4. Sleep

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Sleep features assessed by polygraphy

  5. Cognitive function

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Cognitive function assessed by the Montreal Cognitive Assessment questionnaire

  6. Health-related quality of life

    Time frame: Before intervention; right after intervention; 2 months after intervention

    Health-related quality of life assessed by the SF-36 questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel Vergès, PhD

CONTACT

[email protected]

+33476766860

Stéphane Doutreleau, MD, PhD

CONTACT

[email protected]

+33476767773

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: HYPOXAGE

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Sep 17, 2021
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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