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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048680
Other study ID # 38RC20.460
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 13, 2021
Est. completion date September 2024

Study information

Verified date May 2023
Source University Hospital, Grenoble
Contact Stéphane Doutreleau, MD, PhD
Phone +33476767773
Email sdoutreleau@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date September 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Procedure:
Hypoxia and/or Exercise
Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.

Locations

Country Name City State
France CHU Grenoble Alpes La Tronche Auvergne Rhône-Alpes

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Peak oxygen uptake Peak oxygen uptake during a cardiopulmonary exercise test Before intervention; right after intervention; 2 months after intervention
Secondary Flow-mediated dilation Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery Before intervention; right after intervention; 2 months after intervention
Secondary Blood pressure 24h (systolic, diastolic and mean) blood pressure assessment Before intervention; right after intervention; 2 months after intervention
Secondary Sleep Sleep features assessed by polygraphy Before intervention; right after intervention; 2 months after intervention
Secondary Cognitive function Cognitive function assessed by the Montreal Cognitive Assessment questionnaire Before intervention; right after intervention; 2 months after intervention
Secondary Health-related quality of life Health-related quality of life assessed by the SF-36 questionnaire Before intervention; right after intervention; 2 months after intervention
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