Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly (HYPOXAGE)
Primary Purpose
Hypoxia, Cerebral Hypoxia, Brain Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hypoxia and/or Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Hypoxia
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.
Sites / Locations
- CHU Grenoble AlpesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Active Comparator
Arm Label
Hypoxia - Rest
Normoxia - Rest
Hypoxia - Exercise
Normoxia - Exercise
Arm Description
Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.
Sessions of normoxia at rest; 3 sessions/week; 8 weeks.
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks.
Outcomes
Primary Outcome Measures
Middle cerebral artery flow velocity
Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)
Secondary Outcome Measures
Peak oxygen uptake
Peak oxygen uptake during a cardiopulmonary exercise test
Flow-mediated dilation
Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery
Blood pressure
24h (systolic, diastolic and mean) blood pressure assessment
Sleep
Sleep features assessed by polygraphy
Cognitive function
Cognitive function assessed by the Montreal Cognitive Assessment questionnaire
Health-related quality of life
Health-related quality of life assessed by the SF-36 questionnaire
Full Information
NCT ID
NCT05048680
First Posted
September 8, 2021
Last Updated
May 22, 2023
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT05048680
Brief Title
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Acronym
HYPOXAGE
Official Title
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Cerebral Hypoxia, Brain Diseases, Exercise, Aging, Cognitive Decline, Healthy Aging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind (participant and research team) study in relation to the gas being delivered (normoxic or hypoxic mixture) during intervention.
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypoxia - Rest
Arm Type
Experimental
Arm Description
Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.
Arm Title
Normoxia - Rest
Arm Type
Placebo Comparator
Arm Description
Sessions of normoxia at rest; 3 sessions/week; 8 weeks.
Arm Title
Hypoxia - Exercise
Arm Type
Experimental
Arm Description
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.
Arm Title
Normoxia - Exercise
Arm Type
Active Comparator
Arm Description
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
Hypoxia and/or Exercise
Intervention Description
Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
Primary Outcome Measure Information:
Title
Middle cerebral artery flow velocity
Description
Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)
Time Frame
Before intervention; right after intervention; 2 months after intervention
Secondary Outcome Measure Information:
Title
Peak oxygen uptake
Description
Peak oxygen uptake during a cardiopulmonary exercise test
Time Frame
Before intervention; right after intervention; 2 months after intervention
Title
Flow-mediated dilation
Description
Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery
Time Frame
Before intervention; right after intervention; 2 months after intervention
Title
Blood pressure
Description
24h (systolic, diastolic and mean) blood pressure assessment
Time Frame
Before intervention; right after intervention; 2 months after intervention
Title
Sleep
Description
Sleep features assessed by polygraphy
Time Frame
Before intervention; right after intervention; 2 months after intervention
Title
Cognitive function
Description
Cognitive function assessed by the Montreal Cognitive Assessment questionnaire
Time Frame
Before intervention; right after intervention; 2 months after intervention
Title
Health-related quality of life
Description
Health-related quality of life assessed by the SF-36 questionnaire
Time Frame
Before intervention; right after intervention; 2 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Doutreleau, MD, PhD
Phone
+33476767773
Email
sdoutreleau@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Vergès, PhD
Phone
+33476766860
Email
sverges@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Doutreleau, MD, PhD
Organizational Affiliation
CHU Grenoble Alpes, Grenoble Alpes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble Alpes
City
La Tronche
State/Province
Auvergne Rhône-Alpes
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Doutreleau, MD, PhD
Phone
+33476767773
Email
sdoutreleau@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Samuel Vergès, PhD
Phone
+33476766860
Email
sverges@chu-grenoble.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan at this point in time.
Learn more about this trial
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
We'll reach out to this number within 24 hrs