Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

NCT ID: NCT05048680

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-13
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Hypoxia - Rest

Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.

Group Type: EXPERIMENTAL

Hypoxia and/or Exercise

Intervention Type: PROCEDURE

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

Normoxia - Rest

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

Group Type: PLACEBO_COMPARATOR

Hypoxia and/or Exercise

Intervention Type: PROCEDURE

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

Hypoxia - Exercise

Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.

Group Type: EXPERIMENTAL

Hypoxia and/or Exercise

Intervention Type: PROCEDURE

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

Normoxia - Exercise

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

Group Type: ACTIVE_COMPARATOR

Hypoxia and/or Exercise

Intervention Type: PROCEDURE

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

Interventions

Hypoxia and/or Exercise

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane Doutreleau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes, Grenoble Alpes University

Locations

CHU Grenoble Alpes

La Tronche, Auvergne-Rhône-Alpes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane Doutreleau, MD, PhD

Role: CONTACT

sdoutreleau@chu-grenoble.fr

+33476767773

Samuel Vergès, PhD

Role: CONTACT

sverges@chu-grenoble.fr

+33476766860

Facility Contacts

Stéphane Doutreleau, MD, PhD

Role: primary

sdoutreleau@chu-grenoble.fr

+33476767773

Samuel Vergès, PhD

Role: backup

sverges@chu-grenoble.fr

+33476766860

Other Identifiers

38RC20.460

Identifier Type: -

Identifier Source: org_study_id