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临床试验/NCT04199949
NCT04199949已完成不适用

Effects of Five Days of Physical Inactivity on Endothelial Function in Healthy Humans

University of Nottingham2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery

研究概览

简要总结

Physical inactivity is a significant predictor of major non-communicable diseases such as type 2 diabetes (7%), cardiovascular disease (6%), musculoskeletal disorders and some types of cancer, and has been proposed to be the 4th leading cause of death worldwide. The investigators aim is to assess the vascular (endothelial) function before and after a 5-day period of reduced activity of upper and lower limbs via an arm sling and daily step counts reduction, respectively, in healthy participants. Twelve young (ages of 18 - 35 years), healthy, males and females, recreationally active with a body mass index between 18 and 27 kg/m2 will be recruited. The participants will then randomly undergo two 5-day interventions: (A) 5 consecutive days of habitual daily levels of physical activity and matched food intake (Control trial). (B) 5 consecutive days of reduced step count by 80% compared to the Control trial combined with their non-dominant arm placed in a sling and a reduction in food (energy) intake (~20%) to match the reduction in energy expenditure induced by inactivity (Inactivity trial). On days 1 and 6 of each experimental trial, the endothelial function of the brachial and popliteal arteries, and hand grip strength will be measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Non-smoking
  • Age (18-35 years old)
  • Body mass index (BMI) of 18-27 kg/m2
  • Recreationally active
  • Ability to give informed consent

排除标准

  • Any metabolic (e.g. diabetes), endocrine (e.g. hyperthyroidism) or cardiovascular (e.g. heart or blood) abnormalities including hypertension or heart failure
  • Clinically significant abnormalities on screening including ECG abnormalities
  • Taking routine medication that may alter cardiovascular function and blood flow (e.g. blood pressure-lowering drugs or drugs that cause hypertension)
  • Well-trained individuals
  • On an energy-restricted diet or seeking to lose weight
  • High alcohol consumption (<3-4 units/day)

结局指标

主要结局

Change from baseline of flow-mediated vasodilatation (FMD) of the brachial artery

时间窗: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm

The FMD of the brachial artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes

Change from baseline of flow-mediated vasodilatation (FMD) of the popliteal artery

时间窗: Over 6 minutes and 20 seconds on day 1 and day 6 of each study arm

The FMD of the popliteal artery will be measured using an ultrasound collected at baseline and continuously for 80 seconds post-arm occlusion for 5 minutes

次要结局

  • Hand grip strength(3 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Moira Taylor

Dr Moira A Taylor

University of Nottingham

研究点 (2)

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