跳至主要内容
临床试验/NCT05048680
NCT05048680招募中不适用

Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年10月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
Middle cerebral artery flow velocity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-blind (participant and research team) study in relation to the gas being delivered (normoxic or hypoxic mixture) during intervention.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Hypoxia - Rest

Experimental

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

干预措施: Hypoxia and/or Exercise (Procedure)

Normoxia - Rest

Placebo Comparator

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

干预措施: Hypoxia and/or Exercise (Procedure)

Hypoxia - Exercise

Experimental

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

干预措施: Hypoxia and/or Exercise (Procedure)

Normoxia - Exercise

Active Comparator

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

干预措施: Hypoxia and/or Exercise (Procedure)

结局指标

主要结局

Middle cerebral artery flow velocity

时间窗: Before intervention; right after intervention; 2 months after intervention

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

次要结局

  • 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)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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