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临床试验/NCT02523716
NCT02523716终止不适用

Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity

University of Limerick0 个研究点目标入组 8 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
主要终点
Change in Cardio pulmonary functional variables

研究概览

简要总结

To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.

详细描述

Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).

Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.

The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male and female individuals aged 50-70 years with sedentary lifestyles.

排除标准

  • Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
  • Non-availability and/or suitability to complete the required residential period within the altitude centre.

结局指标

主要结局

Change in Cardio pulmonary functional variables

时间窗: Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.

Assess cardio pulmonary functional variables using cardio pulmonary exercise testing (CPET) prior and following participants completing each arm of the study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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