Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

NCT05048680 | Unknown DMC

• 1 other identifier: 38RC20.460
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Peak oxygen uptake

  Before intervention; right after intervention; 2 months after intervention

• Flow-mediated dilation

  Before intervention; right after intervention; 2 months after intervention

• Blood pressure

  Before intervention; right after intervention; 2 months after intervention

• Sleep

  Before intervention; right after intervention; 2 months after intervention

• Cognitive function

  Before intervention; right after intervention; 2 months after intervention

Study Arms (4)

Hypoxia - Rest

EXPERIMENTAL

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

Normoxia - Rest

PLACEBO COMPARATOR

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

Procedure: Hypoxia and/or Exercise

Hypoxia - Exercise

EXPERIMENTAL

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

Normoxia - Exercise

ACTIVE COMPARATOR

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

Procedure: Hypoxia and/or Exercise

Interventions

Hypoxia and/or Exercise PROCEDURE

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

Hypoxia - Exercise; Hypoxia - Rest; Normoxia - Exercise; Normoxia - Rest

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

La Tronche, Auvergne-Rhône-Alpes, 38700, France

RECRUITING

MeSH Terms

Conditions

Hypoxia; Hypoxia, Brain; Brain Diseases; Motor Activity; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Nervous System Diseases; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stéphane Doutreleau, MD, PhD

  CHU Grenoble Alpes, Grenoble Alpes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Doutreleau, MD, PhD

CONTACT

+33476767773; sdoutreleau@chu-grenoble.fr

Samuel Vergès, PhD

CONTACT

+33476766860; sverges@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind (participant and research team) study in relation to the gas being delivered (normoxic or hypoxic mixture) during intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: October 13, 2021
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)