Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Middle cerebral artery flow velocity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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.
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Hypoxia - Rest
Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest.
Intervention: Hypoxia and/or Exercise (Procedure)
Normoxia - Rest
Sessions of normoxia at rest; 3 sessions/week; 8 weeks.
Intervention: Hypoxia and/or Exercise (Procedure)
Hypoxia - Exercise
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group.
Intervention: Hypoxia and/or Exercise (Procedure)
Normoxia - Exercise
Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks.
Intervention: Hypoxia and/or Exercise (Procedure)
Outcomes
Primary Outcomes
Middle cerebral artery flow velocity
Time Frame: Before intervention; right after intervention; 2 months after intervention
Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)
Secondary Outcomes
- Cognitive function(Before intervention; right after intervention; 2 months after intervention)
- Health-related quality of life(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)
- Peak oxygen uptake(Before intervention; right after intervention; 2 months after intervention)
- Flow-mediated dilation(Before intervention; right after intervention; 2 months after intervention)