HYPOXAGE: Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT05048680
Collaborator
(none)
64
1
4
22.6
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hypoxia and/or Exercise
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind (participant and research team) study in relation to the gas being delivered (normoxic or hypoxic mixture) during intervention.
Primary Purpose:
Prevention
Official Title:
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Actual Study Start Date :
Oct 13, 2021
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Middle cerebral artery flow velocity [Before intervention; right after intervention; 2 months after intervention]

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

Secondary Outcome Measures

  1. Peak oxygen uptake [Before intervention; right after intervention; 2 months after intervention]

    Peak oxygen uptake during a cardiopulmonary exercise test

  2. Flow-mediated dilation [Before intervention; right after intervention; 2 months after intervention]

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

  3. Blood pressure [Before intervention; right after intervention; 2 months after intervention]

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

  4. Sleep [Before intervention; right after intervention; 2 months after intervention]

    Sleep features assessed by polygraphy

  5. Cognitive function [Before intervention; right after intervention; 2 months after intervention]

    Cognitive function assessed by the Montreal Cognitive Assessment questionnaire

  6. Health-related quality of life [Before intervention; right after intervention; 2 months after intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Grenoble Alpes La Tronche Auvergne Rhône-Alpes France 38700

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT05048680
Other Study ID Numbers:
  • 38RC20.460
First Posted:
Sep 17, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022